Exercise Prescription Guided by Heart Rate Variability in Breast Cancer Patients

Effects of Physical Exercise, and Its Prescription Guided by Heart Rate Variability, on the Cardiotoxicity, Physical and Psychological Health of Breast Cancer Patients

Breast cancer is a chronic disease that has seen a boom in research into its treatments, improvements and effects in recent decades. These advances have also highlighted the need to use physical exercise as a countermeasure to reduce the cardiotoxicity of pharmacological treatments. Patients need a correct daily individualisation of the exercise dose necessary to produce the physiological, physical and psychological benefits. To this end, the present study will use, in a novel way in this population, heart rate variability (HRV) as a measure of training prescription. The primary objective of this randomised clinical trial is to analyse the effects of a physical exercise programme planned according to daily HRV in breast cancer patients after chemotherapy treatment. For this purpose, a 16-week intervention will be carried out with 90 breast cancer patients distributed in 3 groups (control group, conventional preprogrammed physical exercise training group and physical exercise group with HRV daily programming). Cardiorespiratory capacity, strength, flexibility, agility, balance, body composition, quality of life, fatigue, functionality, self-esteem, anxiety and depression of patients before and after the intervention will be evaluated in order to compare the effects of exercise and its programming.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; Cardiotoxicity; Autonomic Imbalance
• Intervention / Treatment: Other: Physical exercise program

Detailed Description

The intervention of 16 weeks will include exercise programmes of 48 sessions conducted three times per week for two of the three study groups. These groups will be: a group participating in a conventional training programme, based on a preplanned intensity progression; and, a group of participants involved in an exercise programme which will vary the exercise intensity regarding patients' daily Heart Rate Variability. Each session will include a warm-up, the main part of cardiovascular and strength training and a cool-down including stretching exercises.

All the participants will be evaluated before and after the intervention measuring clinical, physical and psychosocial assessments. The clinical variables will be evaluated in patients' reference hospital and will involve medical history registers, cardiotoxicity variables, blood analysis and inflammatory factors measures. Physical and psychosocial variables measurement will be carried out in a sports centre and will include the assessment of: body composition, heart rate variability, cardiorespiratory capacity, upper and lower extremities' strength and flexibility, agility and balance, quality of life, fatigue, functionality, life satisfaction, self-esteem, anxiety and depression, shoulder mobility perception, kinesiophobia, physical activity level and exercise motivation.

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana Myriam Lavín-Pérez; Phone Number: 695932730; Email: am.lavin.2018@alumnos.urjc.es

Study Locations

• Spain
  • Cantabria
    • Santander, Cantabria, Spain, 39011
      • GOfit
      • Contact: Ana Myriam Lavín-Pérez; Phone Number: 695932730; Email: am.lavin.2018@alumnos.urjc.es
      • Sub-Investigator: Alfonso Jiménez, Professor
      • Sub-Investigator: Daniel Collado-Mateo, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Being between 18 and 65 years
• Being a breast cancer patient with luminal or triple-negative
• Having completed the radiotherapy treatment, after chemotherapy, approximately one month ago.
• Be able to perform the proposed tests safely

Exclusion Criteria:

• Being undergoing radiotherapy treatment or scheduled for surgery
• Having metastasic cancer
• Not having any serious psychiatric illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group (CG); Participants will continue with their daily life and usual care.
Experimental: Traditional periodization exercise group (TEG); Participants will participate in a physical exercise program with a preplanned intensity progression.	Other: Physical exercise program; The physical exercise programme will last 16 weeks where participants will do three weekly sessions of 60 minutes, approximately. In these training sessions, cardiovascular and strength components will be worked out, planned from moderate to high intensity in the TEG and unique high intensity in the HRVG. The training programme will be divided into three mesocycles from neuromuscular adaptation to reach, in last period, the highest loads and cardiovascular levels. Each session will include a warm-up, a main part and a cool-down with stretching and mobility exercises. The difference between the interventions of the HRVG and TEG will be in the planning of the intensity of the cardiovascular exercises and the weight to be lifted in the strength exercises. The first session of both programmes will have the same intensity but depending on how the heart rate variability of the HRVG patients reacts to, the weight and the intensity will be individualised each day.
Experimental: Heart Rate Variability exercise group (HRVG); Participants will participate in a physical exercise program guide by participants' daily heart rate variability to plan the intensity progression.	Other: Physical exercise program; The physical exercise programme will last 16 weeks where participants will do three weekly sessions of 60 minutes, approximately. In these training sessions, cardiovascular and strength components will be worked out, planned from moderate to high intensity in the TEG and unique high intensity in the HRVG. The training programme will be divided into three mesocycles from neuromuscular adaptation to reach, in last period, the highest loads and cardiovascular levels. Each session will include a warm-up, a main part and a cool-down with stretching and mobility exercises. The difference between the interventions of the HRVG and TEG will be in the planning of the intensity of the cardiovascular exercises and the weight to be lifted in the strength exercises. The first session of both programmes will have the same intensity but depending on how the heart rate variability of the HRVG patients reacts to, the weight and the intensity will be individualised each day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline Troponin	A haemogram will be carried out to analyse patients' Troponin I and T to detect their cardiotoxicity levels. Troponin results will be reported in ng/L.	At baseline
After intervention Troponin	A haemogram will be carried out to analyse patients' Troponin I and T to detect their cardiotoxicity levels and the change produced after the intervention. Troponin results will be reported in ng/L.	Immediately after the intervention
3 months after intervention Troponin	A haemogram will be carried out to analyse patients' Troponin I and T to detect their cardiotoxicity levels and the changes produced 3 months after the intervention. Troponin results will be reported in ng/L.	3 months after the intervention ending
6 months after intervention Troponin	A haemogram will be carried out to analyse patients' Troponin I and T to detect their cardiotoxicity levels and the changes produced 6 months after the intervention. Troponin results will be reported in ng/L.	6 months after the intervention ending
Baseline Brain Natriuretic Peptide	A haemogram will be carried out to analyse patients' BNP to assess their cardiotoxicity levels. BNP results will be reported in pg/ml.	At baseline
After intervention Brain Natriuretic Peptide	A haemogram will be carried out to analyse patients' BNP to assess their cardiotoxicity levels and the change produced after the intervention. BNP results will be reported in pg/ml.	Immediately after the intervention
3 months after intervention Brain Natriuretic Peptide	A haemogram will be carried out to analyse patients' BNP to assess their cardiotoxicity levels and the change produced 3 after the intervention. BNP results will be reported in pg/ml.	3 months after the intervention ending
6 months after intervention Brain Natriuretic Peptide	A haemogram will be carried out to analyse patients' BNP to assess their cardiotoxicity levels and the change produced 6 after the intervention. BNP results will be reported in pg/ml.	6 months after the intervention ending
Baseline left ventricular systolic and diastolic volume	An echocardiogram will be performed to measure left ventricular systolic and diastolic volume in mL.	At Baseline
After intervention left ventricular systolic and diastolic volume	An echocardiogram will be performed to measure left ventricular systolic and diastolic volume in mL and it changes after the intervention.	Immediately after the intervention ending
3 months after intervention left ventricular systolic and diastolic volume	An echocardiogram will be performed to measure left ventricular systolic and diastolic volume in mL and it changes 3 months after the intervention.	3 months after the intervention ending
6 months after intervention left ventricular systolic and diastolic volume	An echocardiogram will be performed to measure left ventricular systolic and diastolic volume in mL and it changes 6 months after the intervention.	6 months after the intervention ending
Baseline left ventricular ejection fraction	By an echocardiogram, patients' % of LVEF will be assessed due to its possible modification caused by cardiotoxicity.	At baseline
After intervention left ventricular ejection fraction	By an echocardiogram, patients' % of LVEF will be assessed to measure its results and its change after the intervention.	Immediately after the intervention
3 months after intervention left ventricular ejection fraction	By an echocardiogram, patients' % of LVEF will be assessed to measure its results and its change 3 months after the intervention.	3 months after the intervention ending
6 months after intervention left ventricular ejection fraction	By an echocardiogram, patients' % of LVEF will be assessed to measure its results and its change 6 months after the intervention.	6 months after the intervention ending
Baseline time domain heart rate variability measures	The assessment of heart rate variability will be performed with a Polar chest strap and electrocardiogram. Participants will remain in the supine position for 10 minutes to correctly obtain 5 minutes of a stable signal. After removal of artefacts, the standard deviation time domains of all RR intervals (SDNN) in ms, the mean ad all RR intervals in ms and the root mean square of the sum of squared RR interval differences in ms (RMSSD) will be recorded.	At baseline
After intervention time-domain heart rate variability measures	The assessment of heart rate variability will be performed with a Polar chest strap and electrocardiogram. Participants will remain in the supine position for 10 minutes to correctly obtain 5 minutes of a stable signal. After removal of artefacts, the standard deviation time domains of all RR intervals (SDNN) in ms, the mean ad all RR intervals in ms and the root mean square of the sum of squared RR interval differences in ms (RMSSD) will be recorded after the intervention.	Immediately after the intervention
3 months after intervention time-domain heart rate variability measures	The assessment of heart rate variability will be performed with a Polar chest strap and electrocardiogram. Participants will remain in the supine position for 10 minutes to correctly obtain 5 minutes of a stable signal. After removal of artefacts, the standard deviation time domains of all RR intervals (SDNN) in ms, the mean ad all RR intervals in ms and the root mean square of the sum of squared RR interval differences in ms (RMSSD) will be recorded 3 months after the intervention.	3 months after the intervention ending
6 months after intervention time-domain heart rate variability measures	The assessment of heart rate variability will be performed with a Polar chest strap and electrocardiogram. Participants will remain in the supine position for 10 minutes to correctly obtain 5 minutes of a stable signal. After removal of artefacts, the standard deviation time domains of all RR intervals (SDNN) in ms, the mean ad all RR intervals in ms and the root mean square of the sum of squared RR interval differences in ms (RMSSD) will be recorded 6 months after the intervention.	6 months after the intervention ending
During intervention time-domain heart rate variability measures	Daily heart rate variability will be measured using the HRV4Training application, a validated mobile application that allows HRV values to be obtained by photoplethysmography (rMSSD, SDNN, AVNN, pNN50 and heart rate).	During the intervention ending
Baseline frequency domain heart rate variability measures	The assessment of heart rate variability will be performed with a Polar chest strap and electrocardiogram. Participants will remain in the supine position for 10 minutes to correctly obtain 5 minutes of a stable signal. After removal of artefacts, the frequency measures of low frequency (LF, 0.04-0.15 Hz) in ms2 and n.u, high frequency (HF, 0.15-0.4 Hz) ms2 and n.u, total power in ms2 and LF/HF ratio will be calculated.	At baseline
After intervention frequency domain heart rate variability measures	The assessment of heart rate variability will be performed with a Polar chest strap and electrocardiogram. Participants will remain in the supine position for 10 minutes to correctly obtain 5 minutes of a stable signal. After removal of artefacts, the frequency measures of low frequency (LF, 0.04-0.15 Hz) in ms2 and n.u, high frequency (HF, 0.15-0.4 Hz) ms2 and n.u, total power in ms2 and LF/HF ratio will be calculated after intervention.	Immediately after the intervention
3 months after intervention frequency domain heart rate variability measures	The assessment of heart rate variability will be performed with a Polar chest strap and electrocardiogram. Participants will remain in the supine position for 10 minutes to correctly obtain 5 minutes of a stable signal. After removal of artefacts, the frequency measures of low frequency (LF, 0.04-0.15 Hz) in ms2 and n.u, high frequency (HF, 0.15-0.4 Hz) ms2 and n.u, total power in ms2 and LF/HF ratio will be calculated 3 months after the intervention.	3 months after the intervention ending
6 months after intervention frequency domain heart rate variability measures	The assessment of heart rate variability will be performed with a Polar chest strap and electrocardiogram. Participants will remain in the supine position for 10 minutes to correctly obtain 5 minutes of a stable signal. After removal of artefacts, the frequency measures of low frequency (LF, 0.04-0.15 Hz) in ms2 and n.u, high frequency (HF, 0.15-0.4 Hz) ms2 and n.u, total power in ms2 and LF/HF ratio will be calculated 6 months after the intervention.	6 months after the intervention ending
During intervention frequency domain heart rate variability measures	Daily heart rate variability will be measured using the HRV4Training application, a validated mobile application that allows HRV values to be obtained by photoplethysmography (LF, HF, TP, LF/HF and recovery points)	During the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline heart rate rhyme	A resting electrocardiogram will be used to obtain patients' normal values for heart rate measurements in bpm, I-axis and aVF, Q-T interval, QRS complex, S-T segment and T-wave, in ms. Moreover, resting heart rate will be assessed by a Polar chest band.	At baseline
After intervention heart rate rhyme	A resting electrocardiogram will be used to obtain patients' normal values for heart rate measurements in bpm, I-axis and aVF, Q-T interval, QRS complex, S-T segment and T-wave, in ms, and get after intervention results. Moreover, resting heart rate will be assessed by a Polar chest band.	Immediately after the intervention
3 months after intervention heart rate rhyme	A resting electrocardiogram will be used to obtain patients' normal values for heart rate measurements in bpm, I-axis and aVF, Q-T interval, QRS complex, S-T segment and T-wave, in ms, and get its results 3 months after the intervention. Moreover, resting heart rate will be assessed by a Polar chest band.	3 months after the intervention ending
6 months after intervention heart rate rhyme	A resting electrocardiogram will be used to obtain patients' normal values for heart rate measurements in bpm, I-axis and aVF, Q-T interval, QRS complex, S-T segment and T-wave, in ms, and get its results 6 months after the intervention. Moreover, resting heart rate will be assessed by a Polar chest band.	6 months after the intervention
Baseline tumor necrosis factor	Through a blood analysis TFN, in pg/mL, will be measured to evaluate patients' inflammation.	At baseline
After intervention tumor necrosis factor	Through a blood analysis TFN, in pg/mL, will be measured to evaluate patients' inflammation after the intervention.	Immediately after the intervention
3 months after intervention tumor necrosis factor	Through a blood analysis TFN, in pg/mL, will be measured to evaluate patients' inflammation 3 months after the intervention.	3 months after the intervention ending
6 months after intervention tumor necrosis factor	Through a blood analysis TFN, in pg/mL, will be measured to evaluate patients' inflammation 6 months after the intervention.	6 months after the intervention ending
Baseline interleukins measurement	The inflammation will be assessed by blood interleukins will include IL-6, IL-8, IL-1b, IL-1ra and IL-10 values, in pg/m.	At baseline
After intervention interleukins measurement	The inflammation will be assessed by blood interleukins will include IL-6, IL-8, IL-1b, IL-1ra and IL-10 values, in pg/m, immediately after the intervention.	Immediately after the intervention.
3 months after intervention interleukins measurement	The inflammation will be assessed by blood interleukins will include IL-6, IL-8, IL-1b, IL-1 and IL-10 values, in pg/m, 3 months after the intervention.	3 months after the intervention ending
6 months after intervention interleukins measurement	The inflammation will be assessed by blood interleukins will include IL-6, IL-8, IL-1b, IL-1ra and IL-10 values, in pg/m, 6 months after the intervention.	6 months after the intervention ending
Baseline C-reactive protein measure	C-reactive protein (CRP), measured in mg/L will be evaluated to get patients' pro-inflammatory data.	At baseline
After intervention C-reactive protein measure	C-reactive protein (CRP), measured in mg/L will be evaluated to get patients' pro-inflammatory data after the intervention.	Immediately after the intervention.
3 months after intervention C-reactive protein measure	C-reactive protein (CRP), measured in mg/L will be evaluated to get patients' pro-inflammatory data 3 months after the intervention.	3 months after the intervention ending
6 months after intervention C-reactive protein measure	C-reactive protein (CRP), measured in mg/L will be evaluated to get patients' pro-inflammatory data 6 months after the intervention.	6 months after the intervention ending
Baseline monocyte chemotactic protein measure	Monocyte chemotactic protein (MCP-1), measured in pg/mL will be evaluated to get patients' pro-inflammatory data.	At baseline
After intervention monocyte chemotactic protein measure	Monocyte chemotactic protein (MCP-1), measured in pg/mL will be evaluated to get patients' pro-inflammatory data after the intervention.	Immediately after the intervention.
3 months after intervention monocyte chemotactic protein measure	Monocyte chemotactic protein (MCP-1), measured in pg/mL will be evaluated to get patients pro-inflammatory data 3 months after the intervention.	3 months after the intervention ending
6 months after intervention monocyte chemotactic protein measure	Monocyte chemotactic protein (MCP-1), measured in pg/mL will be evaluated to get patients pro-inflammatory data 6 months after the intervention.	6 months after the intervention ending
Baseline glucose measure	Glucose, in mg/dl, will be measure through a blood test due to be related to cancer prognosis and cardiovascular risk.	At baseline
After intervention glucose measure	Glucose, in mg/dl, will be measure after intervention through a blood test due to be related to cancer prognosis and cardiovascular risk.	Immediately after the intervention.
3 months after intervention glucose measure	Glucose, in mg/dl, will be measure through a blood test due to be related to cancer prognosis and cardiovascular risk.	3 months after the intervention ending
6 months after intervention glucose measure	Glucose, in mg/dl, will be measure through a blood test due to be related to cancer prognosis and cardiovascular risk.	6 months after the intervention ending
Baseline cholesterol measure	Low-density lipoprotein and high-density lipoprotein, measured in mg/dL, will be assessed by a blood test due to be related to cancer prognosis and cardiovascular risk.	At baseline
After intervention cholesterol measure	Low-density lipoprotein and high-density lipoprotein, measured in mg/dL, will be measure after intervention by a blood test due to be related to cancer prognosis and cardiovascular risk.	Immediately after the intervention.
3 months after intervention cholesterol measure	Low-density lipoprotein and high-density, measured in mg/dL, will be measure 3 months after the intervention by a blood test due to be related to cancer prognosis and cardiovascular risk.	3 months after the intervention ending
6 months after intervention cholesterol measure	Low-density lipoprotein and high-density, measured in mg/dL, will be measure 6 months after the intervention by a blood test due to be related to cancer prognosis and cardiovascular risk.	6 months after the intervention ending
Baseline blood pressure measures	Measurements of blood pressure will be performed using a validated oscillometer. Participants will remain at rest for five minutes before the assessment. They will place their left arm, on which the measurement will be taken, on the table so that the cuff is at the level of the heart, 2 cm from the elbow. In addition, any clothing that may alter the results shall be removed. Once in this position, the air tube of the cuff shall be placed on the front of the upper arm in line with the middle finger and the blue arrow on the cuff. Systolic and diastolic blood pressure data, measured in mmHg, shall be taken, and then the mean arterial pressure = (systolic blood pressure+ (2*diastolic blood pressure))/3 shall be calculated.	At baseline
After intervention blood pressure measures	Measurements of blood pressure after the intervention will be performed using a validated oscillometer. Participants will remain at rest for five minutes before the assessment. They will place their left arm, on which the measurement will be taken, on the table so that the cuff is at the level of the heart, 2 cm from the elbow. In addition, any clothing that may alter the results shall be removed. Once in this position, the air tube of the cuff shall be placed on the front of the upper arm in line with the middle finger and the blue arrow on the cuff. Systolic and diastolic blood pressure data, measured in mmHg, shall be taken, and then the mean arterial pressure = (systolic blood pressure+ (2*diastolic blood pressure))/3 shall be calculated.	Immediately after the intervention.
3 months after intervention blood pressure measures	Measurements of blood pressure 3 months after the intervention will be performed using a validated oscillometer. Participants will remain at rest for five minutes before the assessment. They will place their left arm, on which the measurement will be taken, on the table so that the cuff is at the level of the heart, 2 cm from the elbow. In addition, any clothing that may alter the results shall be removed. Once in this position, the air tube of the cuff shall be placed on the front of the upper arm in line with the middle finger and the blue arrow on the cuff. Systolic and diastolic blood pressure data, measured in mmHg, shall be taken, and then the mean arterial pressure = (systolic blood pressure+ (2*diastolic blood pressure))/3 shall be calculated.	3 months after the intervention ending
6 months after intervention blood pressure measures	Measurements of blood pressure 6 months after the intervention will be performed using a validated oscillometer. Participants will remain at rest for five minutes before the assessment. They will place their left arm, on which the measurement will be taken, on the table so that the cuff is at the level of the heart, 2 cm from the elbow. In addition, any clothing that may alter the results shall be removed. Once in this position, the air tube of the cuff shall be placed on the front of the upper arm in line with the middle finger and the blue arrow on the cuff. Systolic and diastolic blood pressure data, measured in mmHg, shall be taken, and then the mean arterial pressure = (systolic blood pressure+ (2*diastolic blood pressure))/3 shall be calculated.	6 months after the intervention ending
Baseline body composition weight measures	The weight assessment of body composition will be performed by impedance to obtain patients' global bodyweight, musculoskeletal mass, mineral mass, fat mass and upper and lower extremities segmental fat and lean mass weight. All the measures will be reported in kilograms.	At baseline
After intervention body composition weight measures	The weight assessment of body composition after the intervention will be performed by impedance to obtain patients' global bodyweight, musculoskeletal mass, mineral mass, fat mass and upper and lower extremities segmental fat and lean mass weight. All the measures will be reported in kilograms.	Immediately after the intervention.
3 months after intervention body composition weight measures	The weight assessment of body composition 3 months after the intervention will be performed by impedance to obtain patients' global bodyweight, musculoskeletal mass, mineral mass, fat mass and upper and lower extremities segmental fat and lean mass weight. All the measures will be reported in kilograms.	3 months after the intervention ending
6 months after intervention body composition weight measures	The weight assessment of body composition 6 months after the intervention will be performed by impedance to obtain patients' global bodyweight, musculoskeletal mass, mineral mass, fat mass and upper and lower extremities segmental fat and lean mass weight. All the measures will be reported in kilograms	6 months after the intervention ending
Baseline body composition percentages measures	The assessment of the body fat percentage of the participants is a variable to be taken into consideration. Therefore, thought impedance patients' body fat percentage and upper and lower extremities segmental fat and lean mass percentages will be recorded.	At baseline
After intervention body composition percentages measures	The assessment of the body percentage of the participants is a variable to be taken into consideration. Therefore, thought impedance, patients' body fat percentage and upper and lower extremities segmental fat and lean mass percentages will be recorded after the intervention.	Immediately after the intervention.
3 months after intervention body composition percentages measures	The assessment of the body percentage of the participants is a variable to be taken into consideration. Therefore, thought impedance, patients' body fat percentage and upper and lower extremities segmental fat and lean mass percentages will be recorded 3 months after the intervention.	3 months after the intervention ending
6 months after intervention body composition percentages measures	The assessment of the body percentage of the participants is a variable to be taken into consideration. Therefore, thought impedance, patients' body fat percentage and upper and lower extremities segmental fat and lean mass percentages will be recorded 6 months after the intervention.	6 months after the intervention ending
Baseline body water measures	By employing also impedance body water evaluation, measured in liters, will be carried out.	At baseline
After intervention body water measures	By employing also impedance, body water evaluation, measured in liters, will be carried out after the intervention.	Immediately after the intervention.
3 months after intervention body water measures	By employing also impedance, body water evaluation, measured in liters, will be carried out 3 months after the intervention.	3 months after the intervention ending
6 months after intervention body water measures	By employing also impedance, body water evaluation, measured in liters, will be carried out 6 months after the intervention.	6 months after the intervention ending
Baseline anthropometric measures	Patients' height and body perimeters will be assessed in centimeters. Especially, waist circumference, hip circumference, arm circumferences, leg circumferences will be measured following the guidelines set by the American College of Sports Medicine. Afterward, patients' height will be used together with their corresponding weight to calculate patients Body Mass Index.	At baseline
After intervention anthropometric measures	Patients' height and body perimeters will be assessed in centimeters immediately after the intervention. Especially, waist circumference, hip circumference, arm circumferences, leg circumferences will be measured following the guidelines set by the American College of Sports Medicine. Afterward, patients' height will be used together with their corresponding weight to calculate patients Body Mass Index.	Immediately after the intervention.
3 months after intervention anthropometric measures	Patients' height and body perimeters will be assessed in centimeters 3 months after the end of the intervention. Especially, waist circumference, hip circumference, arm circumferences, leg circumferences will be measured following the guidelines set by the American College of Sports Medicine. Afterward, patients' height will be used together with their corresponding weight to calculate patients Body Mass Index.	3 months after the intervention ending
6 months after intervention anthropometric measures	Patients' height and body perimeters will be assessed in centimeters 6 months after the end of the intervention. Especially, waist circumference, hip circumference, arm circumferences, leg circumferences will be measured following the guidelines set by the American College of Sports Medicine. Afterward, patients' height will be used together with their corresponding weight to calculate patients Body Mass Index.	6 months after the intervention ending
Baseline cardiorespiratory fitness	To record cardiorespiratory fitness, maximum heart rate and patients' perception of exertion, the Bruce incremental submaximal test (modified) was performed on a treadmill. During the test, the patients will wear a chest strap for heart rate monitoring. Thus, following the protocol created by Bruce, the treadmill will start with a 0% incline and a speed of 1.7 m/h which will be maintained for the first 3 minutes. Every 3 minutes, both the speed and the incline will be increased until the participants decide that their fatigue is too great to continue. At the end of the test, the recovery heart rate is recorded 1 minute after stopping the test to assess the recovery rate. Subsequently, the maximum oxygen consumption of each patient (VO2max = 2.282* (time) + 8.545) will be calculated from the formula proposed by the creators.	At baseline
After intervention cardiorespiratory fitness	To record cardiorespiratory fitness after the intervention, maximum heart rate and patients' perception of exertion, the Bruce incremental submaximal test (modified) was performed on a treadmill. During the test, the patients will wear a chest strap for heart rate monitoring. Thus, following the protocol created by Bruce, the treadmill will start with a 0% incline and a speed of 1.7 m/h which will be maintained for the first 3 minutes. Every 3 minutes, both the speed and the incline will be increased until the participants decide that their fatigue is too great to continue. At the end of the test, the recovery heart rate is recorded 1 minute after stopping the test to assess the recovery rate. Subsequently, the maximum oxygen consumption of each patient (VO2max = 2.282* (time) + 8.545) will be calculated from the formula proposed by the creators.	Immediately after the intervention.
3 months after intervention cardiorespiratory fitness	To record cardiorespiratory fitness 3 months after the intervention, maximum heart rate and patients' perception of exertion, the Bruce incremental submaximal test (modified) was performed on a treadmill. During the test, the patients will wear a chest strap for heart rate monitoring. Thus, following the protocol created by Bruce, the treadmill will start with a 0% incline and a speed of 1.7 m/h which will be maintained for the first 3 minutes. Every 3 minutes, both the speed and the incline will be increased until the participants decide that their fatigue is too great to continue. At the end of the test, the recovery heart rate is recorded 1 minute after stopping the test to assess the recovery rate. Subsequently, the maximum oxygen consumption of each patient (VO2max = 2.282* (time) + 8.545) will be calculated from the formula proposed by the creators.	3 months after the intervention ending
6 months after intervention cardiorespiratory fitness	To record cardiorespiratory fitness 6 months after the intervention, maximum heart rate and patients' perception of exertion, the Bruce incremental submaximal test (modified) was performed on a treadmill. During the test, the patients will wear a chest strap for heart rate monitoring. Thus, following the protocol created by Bruce, the treadmill will start with a 0% incline and a speed of 1.7 m/h which will be maintained for the first 3 minutes. Every 3 minutes, both the speed and the incline will be increased until the participants decide that their fatigue is too great to continue. At the end of the test, the recovery heart rate is recorded 1 minute after stopping the test to assess the recovery rate. Subsequently, the maximum oxygen consumption of each patient (VO2max = 2.282* (time) + 8.545) will be calculated from the formula proposed by the creators.	6 months after the intervention ending
Baseline measurement of lower-body strength endurance	Functional strength will be measure by the 30 seconds chair stand test. The patient will stand up, position herself fully stretched, and perform as many repetitions as possible in 30 seconds.	At baseline
After intervention measurement of lower-body strength endurance	Functional strength will be measure by the 30 seconds chair stand test. The patient will stand up, position herself fully stretched, and perform as many repetitions as possible in 30 seconds.	Immediately after the intervention.
3 months after intervention measurement of lower-body strength endurance	Functional strength will be measure by the 30 seconds chair stand test. The patient will stand up, position herself fully stretched, and perform as many repetitions as possible in 30 seconds.	3 months after the intervention ending
6 months after intervention measurement of lower-body strength endurance	Functional strength will be measure by the 30 seconds chair stand test. The patient will stand up, positioning herself fully stretched, and perform as many repetitions as possible in 30 seconds.	6 months after the intervention ending
Baseline maximal strength	The evaluation of maximal strength will be performed by using an encoder for the correct calculation of the Maximum Repetition (RM) from the speed and power generated by moving the weight vertically. The participants will perform 4 tests to assess the different muscular groups' strength (Back Squat Test, Deadlift Test, Lunge Test, Barbell Hip Thrust Test). Concretely, 4-5 repetitions will be performed with incremental weights where the speed of execution decreases.	At baseline
After intervention maximal strength	The evaluation of maximal strength after the intervention will be performed by using an encoder for the correct calculation of the Maximum Repetition (RM) from the speed and power generated by moving the weight vertically. The participants will perform 4 tests to assess the different muscular groups' strength (Back Squat Test, Deadlift Test, Lunge Test, Barbell Hip Thrust Test). Concretely, 4-5 repetitions will be performed with incremental weights where the speed of execution decreases.	Immediately after the intervention.
3 months after intervention maximal strength	The evaluation of maximal strength 3 months after the intervention will be performed by using an encoder for the correct calculation of the Maximum Repetition (RM) from the speed and power generated by moving the weight vertically. The participants will perform 4 tests to assess the different muscular groups' strength (Back Squat Test, Deadlift Test, Lunge Test, Barbell Hip Thrust Test). Concretely, 4-5 repetitions will be performed with incremental weights where the speed of execution decreases.	3 months after the intervention ending
6 months after intervention maximal strength	The evaluation of maximal strength 6 months after the intervention will be performed by using an encoder for the correct calculation of the Maximum Repetition (RM) from the speed and power generated by moving the weight vertically. The participants will perform 4 tests to assess the different muscular groups' strength (Back Squat Test, Deadlift Test, Lunge Test, Barbell Hip Thrust Test). Concretely, 4-5 repetitions will be performed with incremental weights where the speed of execution decreases.	6 months after the intervention ending
Baseline vertical applied force	The force-power will be measured using a countermovement jump test (CMJ) and squat jump test (SJ). From these tests, the maximum force (N) and power (P) exerted during impulse and landing, flight time (ms) and jump height (cm) will be obtained. For the evaluation of the different variables indicated, different technologies will be used such as a jump platform and/or the recording of each of the jumps for subsequent analysis with the validated application of My Jump and Kinovea.	At baseline
After intervention vertical applied force	The after-intervention force-power will be measured using a countermovement jump test (CMJ) and squat jump test (SJ). From these tests, the maximum force (N) and power (P) exerted during impulse and landing, flight time (ms) and jump height (cm) will be obtained. For the evaluation of the different variables indicated, different technologies will be used such as a jump platform and/or the recording of each of the jumps for subsequent analysis with the validated application of My Jump and Kinovea.	Immediately after the intervention.
3 months intervention vertical applied force	The force-power 3 months after the intervention will be measured using a countermovement jump test (CMJ) and squat jump test (SJ). From these tests, the maximum force (N) and power (P) exerted during impulse and landing, flight time (ms) and jump height (cm) will be obtained. For the evaluation of the different variables indicated, different technologies will be used such as a jump platform and/or the recording of each of the jumps for subsequent analysis with the validated application of My Jump and Kinovea.	3 months after the intervention ending
6 months intervention vertical applied force	The force-power 6 months after the intervention will be measured using a countermovement jump test (CMJ) and squat jump test (SJ). From these tests, the maximum force (N) and power (P) exerted during impulse and landing, flight time (ms) and jump height (cm) will be obtained. For the evaluation of the different variables indicated, different technologies will be used such as a jump platform and/or the recording of each of the jumps for subsequent analysis with the validated application of My Jump and Kinovea.	6 months after the intervention ending
Baseline measurement of upper body strength endurance	The strength endurance of the patients will be measured utilizing the 30-second arm curl test reporting the maximum number of repetitions in 30 seconds.	At baseline
After intervention measurement of upper body strength endurance	The strength endurance of the patients after the intervention will be measured employing the 30-second arm curl test reporting the maximum number of repetitions in 30 seconds.	Immediately after the intervention.
3 months after intervention measurement of upper body strength endurance	The strength endurance of the patients 3 months after the intervention will be measured utilizing the 30-second arm curl test reporting the maximum number of repetitions in 30 seconds.	3 months after the intervention ending
6 months after intervention measurement of upper body strength endurance	The strength endurance of the patients 6 months after the intervention will be measured employing the 30-second arm curl test reporting the maximum number of repetitions in 30 seconds.	6 months after the intervention ending
Baseline maximal upper body strength	Maximal strength of different muscular group exercises will be assessed (chest press, shoulder press, bent over row, biceps curl with barbell, Triceps extension with barbell) based on the number of repetitions that the participants are able to perform. An encoder will be used to calculate the Maximum Repetition (RM) by the speed and power generated by moving the weight vertically.	At baseline
After intervention maximal upper body strength	Maximal strength of different muscular group exercises after the intervention will be assessed (chest press, shoulder press, bent over row, biceps curl with barbell, Triceps extension with barbell) based on the number of repetitions that the participants are able to perform. An encoder will be used to calculate the Maximum Repetition (RM) by the speed and power generated by moving the weight vertically.	Immediately after the intervention.
3 months after intervention maximal upper body strength	Maximal strength of different muscular group exercises 3 months after the intervention will be assessed (chest press, shoulder press, bent over row, biceps curl with barbell, Triceps extension with barbell) based on the number of repetitions that the participants are able to perform. An encoder will be used to calculate the Maximum Repetition (RM) by the speed and power generated by moving the weight vertically.	3 months after the intervention ending
6 months after intervention maximal upper body strength	Maximal strength of different muscular group exercises 6 months after the intervention will be assessed (chest press, shoulder press, bent over row, biceps curl with barbell, Triceps extension with barbell) based on the number of repetitions that the participants are able to perform. An encoder will be used to calculate the Maximum Repetition (RM) by the speed and power generated by moving the weight vertically.	6 months after the intervention ending
Baseline measurement of agility and dynamic balance	The 8-foot up-and-go test will be employed to measure dynamic balance and agility, where the participants will get up from the chair and walk as fast as possible to the cone, placed 2,44 meters far away, and around the cone, back to the chair. The outcome measure will be the time spend in seconds.	At baseline
After intervention measurement of agility and dynamic balance	The 8-foot up-and-go test will be employed to measure dynamic balance and agility after the intervention, where the participants will get up from the chair and walk as fast as possible to the cone, placed 2,44 meters far away, and around the cone, back to the chair. The outcome measure will be the time spend in seconds.	Immediately after the intervention.
3 months after intervention measurement of agility and dynamic balance	The 8-foot up-and-go test will be employed to measure dynamic balance and agility 3 months after the intervention, where the participants will get up from the chair and walk as fast as possible to the cone, placed 2,44 meters far away, and around the cone, back to the chair. The outcome measure will be the time spend in seconds.	3 months after the intervention ending
6 months after intervention measurement of agility and dynamic balance	The 8-foot up-and-go test will be employed to measure dynamic balance and agility 6 months after the intervention, where the participants will get up from the chair and walk as fast as possible to the cone, placed 2,44 meters far away, and around the cone, back to the chair. The outcome measure will be the time spend in seconds.	6 months after the intervention ending
Baseline static monopodal balance	The one-leg stand test from the adults ALHPA battery will assess static balance. For this purpose, the patient will be placed in monopodal support, placing the sole on the inside of the knee. The time reached, in seconds, without touching the group with the other foot will be recorded.	At baseline
After intervention static monopodal balance	The one-leg stand test from the adults ALHPA battery will assess static balance after the intervention. For this purpose, the patient will be placed in monopodal support, placing the sole of the foot on the inside of the knee. The time reached, in seconds, without touching the group with the other foot will be recorded.	Immediately after the intervention.
3 months after intervention static monopodal balance	The one-leg stand test from the adults ALHPA battery will assess static balance 3 months after the intervention. For this purpose, the patient will be placed in monopodal support, placing the sole on the inside of the knee. The time reached, in seconds, without touching the group with the other foot will be recorded.	3 months after the intervention ending
6 months after intervention static monopodal balance	The one-leg stand test from the adults ALHPA battery will assess static balance 6 months after the intervention. For this purpose, the patient will be placed in monopodal support, placing the sole of the foot on the inside of the knee. The time reached, in seconds, without touching the group with the other foot will be recorded	6 months after the intervention ending
Baseline measurement of upper body flexibility	Flexibility will be assessed using the Back scratch test, previously used in breast cancer patients and belonging to the Senior Fitness Test battery. During the test, participants will stand upright and try to reach over their head, with their arm in flexion and external rotation, to touch their other hand, which will be placed on their back in a supine position with the arm flexed. The centimeters left or passed from one hand to the other will be noted.	At baseline
After intervention measurement of upper body flexibility	Flexibility after the intervention will be assessed using the Back scratch test, previously used in breast cancer patients and belonging to the Senior Fitness Test battery. During the test, participants will stand upright and try to reach over their head, with their arm in flexion and external rotation, to touch their other hand, which will be placed on their back in a supine position with the arm flexed. The centimeters left or passed from one hand to the other will be noted.	Immediately after the intervention.
3 months after intervention measurement of upper body flexibility	Flexibility 3 months after the intervention will be assessed using the Back scratch test, previously used in breast cancer patients and belonging to the Senior Fitness Test battery. During the test, participants will stand upright and try to reach over their head, with their arm in flexion and external rotation, to touch their other hand, which will be placed on their back in a supine position with the arm flexed. The centimeters left or passed from one hand to the other will be noted.	3 months after the intervention ending
6 months after intervention measurement of upper body flexibility	Flexibility 6 months after the intervention will be assessed using the Back scratch test, previously used in breast cancer patients and belonging to the Senior Fitness Test battery. During the test, participants will stand upright and try to reach over their head, with their arm in flexion and external rotation, to touch their other hand, which will be placed on their back in a supine position with the arm flexed. The centimeters left or passed from one hand to the other will be noted.	6 months after the intervention ending
Baseline measurement of lower body flexibility	Hamstring flexibility will be measured using the V Sit and Reach test where the participant will be seated on the floor with knees fully extended and feet 30 cm apart. A tape measure will be placed on the floor, equidistant between the feet, placing the 0 cm in line with the heels. Pressing the palms of the hands together and keeping the elbows fully extended, the participants shall bend their trunk as far as possible over the tape measure. The results will be expressed in centimeters reporting the distance left or passed from the feet.	At baseline
After intervention measurement of lower body flexibility	Hamstring flexibility after the intervention will be measured using the V Sit and Reach test where the participant will be seated on the floor with knees fully extended and feet 30 cm apart. A tape measure will be placed on the floor, equidistant between the feet, placing the 0 cm in line with the heels. Pressing the palms of the hands together and keeping the elbows fully extended, the participants shall bend their trunk as far as possible over the tape measure. The results will be expressed in centimeters reporting the distance left or passed from the feet.	Immediately after the intervention.
3 months after intervention measurement of lower body flexibility	Hamstring flexibility 3 months after the intervention will be measured using the V Sit and Reach test where the participant will be seated on the floor with knees fully extended and feet 30 cm apart. A tape measure will be placed on the floor, equidistant between the feet, placing the 0 cm in line with the heels. Pressing the palms of the hands together and keeping the elbows fully extended, the participants shall bend their trunk as far as possible over the tape measure. The results will be expressed in centimeters reporting the distance left or passed from the feet.	3 months after the intervention ending
6 months after intervention measurement of lower body flexibility	Hamstring flexibility 6 months after the intervention will be measured using the V Sit and Reach test where the participant will be seated on the floor with knees fully extended and feet 30 cm apart. A tape measure will be placed on the floor, equidistant between the feet, placing the 0 cm in line with the heels. Pressing the palms of the hands together and keeping the elbows fully extended, the participants shall bend their trunk as far as possible over the tape measure. The results will be expressed in centimeters reporting the distance left or passed from the feet.	6 months after the intervention ending
Baseline health-related quality of life measure	Psychological variables will be assessed employing self-administered questionnaires specifically validated for cancer patients. Health-related quality of life will be assessed using the EORTC QLQ-C30 Quality of Life Questionnaire which includes functional and cancer-specific symptom assessment. Higher global scores will mean a higher quality of life.	At baseline
After intervention health-related quality of life measure	Psychological variables will be assessed employing self-administered questionnaires specifically validated for cancer patients. Health-related quality of life will be assessed using the EORTC QLQ-C30 Quality of Life Questionnaire which includes functional and cancer-specific symptom assessment. Higher global scores will mean a higher quality of life.	Immediately after the intervention.
3 months after intervention health-related quality of life measure	Psychological variables will be assessed utilizing self-administered questionnaires specifically validated for cancer patients. Health-related quality of life will be assessed 3 months after the intervention using the EORTC QLQ-C30 Quality of Life Questionnaire which includes functional and cancer-specific symptom assessment. Higher global scores will mean a higher quality of life.	3 months after the intervention ending
6 months after intervention health-related quality of life measure	Psychological variables will be assessed through self-administered questionnaires specifically validated for cancer patients. Health-related quality of life 6 months after the intervention will be assessed using the EORTC QLQ-C30 Quality of Life Questionnaire which includes functional and cancer-specific symptom assessment. Higher global scores will mean a higher quality of life.	6 months after the intervention ending
Baseline cancer-related fatigue	To assess cancer-related fatigue, the FACT-F questionnaire will be employed. It includes 13 items where patients will select their fatigue perception with a Likert scale from 1 to 5 being 1 the lowest fatigue score and 5 the highest.	At baseline
After intervention cancer-related fatigue	To assess cancer-related fatigue after the intervention, the FACT-F questionnaire will be employed. It includes 13 items where patients will select their fatigue perception with a Likert scale from 1 to 5 being 1 the lowest fatigue score and 5 the highest.	Immediately after the intervention.
3 months after intervention cancer-related fatigue	To assess cancer-related fatigue 3 months after the intervention, the FACT-F questionnaire will be employed. It includes 13 items where patients will select their fatigue perception with a Likert scale from 1 to 5 being 1 the lowest fatigue score and 5 the highest.	3 months after the intervention ending
6 months after intervention cancer-related fatigue	To assess cancer-related fatigue 6 months after the intervention, the FACT-F questionnaire will be employed. It includes 13 items where patients will select their fatigue perception with a Likert scale from 1 to 5 being 1 the lowest fatigue score and 5 the highest.	6 months after the intervention ending
Baseline life satisfaction measure	Life satisfaction will be assessed using the Satisfaction With Life Scale (SWLS) questionnaire. The scale is composed of 5 items to score with a Likert scale from 1 (strongly disagree) to 5 (strongly agree).	At baseline
After intervention life satisfaction measure	Life satisfaction after the intervention will be assessed using the Satisfaction With Life Scale (SWLS) questionnaire. The scale is composed of 5 items to score with a Likert scale from 1 (strongly disagree) to 5 (strongly agree).	Immediately after the intervention.
3 months after intervention life satisfaction measure	Life satisfaction 3 months after the intervention will be assessed using the Satisfaction With Life Scale (SWLS) questionnaire. The scale is composed of 5 items to score with a Likert scale from 1 (strongly disagree) to 5 (strongly agree).	3 months after the intervention ending
6 months after intervention life satisfaction measure	Life satisfaction 6 months after the intervention will be assessed using the Satisfaction With Life Scale (SWLS) questionnaire. The scale is composed of 5 items to score with a Likert scale from 1 (strongly disagree) to 5 (strongly agree).	6 months after the intervention ending
Baseline self-esteem	Patients' level of self-esteem will be assessed using the Rosenberg Self-Esteem Scale which includes 10 items. Participants will have to score each item with a Likert scale from 1 (strongly disagree) to 4 (strongly agree).	At baseline
After intervention self-esteem	Patients' level of self-esteem will be assessed after intervention using the Rosenberg Self-Esteem Scale which includes 10 items. Participants will have to score each item with a Likert scale from 1 (strongly disagree) to 4 (strongly agree).	Immediately after the intervention.
3 months after intervention self-esteem measure	Patients' level of self-esteem will be assessed 3 months after the intervention using the Rosenberg Self-Esteem Scale which includes 10 items. Participants will have to score each item with a Likert scale from 1 (strongly disagree) to 4 (strongly agree).	3 months after the intervention ending
6 months after intervention self-esteem measure	Patients' level of self-esteem will be assessed 6 months after the intervention using the Rosenberg Self-Esteem Scale which includes 10 items. Participants will have to score each item with a Likert scale from 1 (strongly disagree) to 4 (strongly agree).	6 months after the intervention ending
Baseline anxiety and depression perception measure	Anxiety and depression will be evaluated by the HAD Scale (Hospital Anxiety and Depression Scale). It is composed of 14 items and participants will have to choose one from 4 options to select the affirmation which better corresponds to their perception.	At baseline
After intervention anxiety and depression perception measure	Anxiety and depression will be evaluated after intervention by the HAD Scale (Hospital Anxiety and Depression Scale). It is composed by 14 items and participants will have to choose one from 4 options to select the affirmation which better corresponds to their perception.	Immediately after the intervention.
3 months after intervention anxiety and depression perception measure	Anxiety and depression will be evaluated 3 months after the intervention by the HAD Scale (Hospital Anxiety and Depression Scale). It is composed of 14 items and participants will have to choose one from 4 options to select the affirmation which better corresponds to their perception.	3 months after the intervention ending
6 months after intervention anxiety and depression perception measure	Anxiety and depression will be evaluated 6 months after the intervention by the HAD Scale (Hospital Anxiety and Depression Scale). It is composed of 14 items and participants will have to choose one from 4 options to select the affirmation which better corresponds to their perception.	6 months after the intervention ending
Baseline Shoulder disability perception measure	For the assessment of their perception of disability due to shoulder mobility, the Quick DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire will be used. It is an 11- item self-administered survey referenced over 7 days prior to administration.	At baseline
After intervention shoulder disability perception measure	For the assessment of their perception of disability due to shoulder mobility, the Quick DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire will be used after the intervention. It is an 11- item self-administered survey referenced over 7 days prior to administration.	Immediately after the intervention.
3 months after the intervention shoulder disability perception measure	For the assessment of their perception of disability due to shoulder mobility, the Quick DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire will be used 3 months after the intervention. It is an 11- item self-administered survey referenced over 7 days prior to administration.	3 months after the intervention ending
6 months after the intervention shoulder disability perception measure	For the assessment of their perception of disability due to shoulder mobility, the Quick DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire will be used 6 months after the intervention. It is an 11- item self-administered survey referenced over 7 days prior to administration.	6 months after the intervention ending
Baseline physical activity level measure	The International Physical Activity Questionnaire will be administered to assess the physical activity level of patients before starting the exercise programme. Participants will report the activity performed during the prior 7 days specifying the time spent in each type of physical activity.	At baseline
After intervention physical activity level measure	The International Physical Activity Questionnaire will be administered to assess the physical activity level of patients after the end of the programme. Participants will report the activity performed during the prior 7 days specifying the time spent in each type of physical activity.	Immediately after the intervention.
3 months after intervention physical activity level measure	The International Physical Activity Questionnaire will be administered to assess the physical activity level of patients after 3 months of the end of the programme. Participants will report the activity performed during the prior 7 days specifying the time spent in each type of physical activity.	3 months after the intervention ending
6 months after intervention physical activity level measure	The International Physical Activity Questionnaire will be administered to assess the physical activity level of patients after 6 months of the end of the programme. Participants will report the activity performed during the prior 7 days specifying the time spent in each type of physical activity.	6 months after the intervention ending
Baseline exercise motivation	The existence or not of behavioural change/motivation towards exercise will be assessed before the intervention by using the Behaviour Regulation in Physical Exercise Scale (BREQ-2). The BREQ-2 is a 19 item questionnaire that measures the stages of the self-determination continuum concerning motivation to exercise with a 5 point Likert scale (0=not true for me, 4=very true for me).	At baseline
After intervention exercise motivation	The existence or not of behavioural change/motivation towards exercise will be assessed after the intervention by using the Behaviour Regulation in Physical Exercise Scale (BREQ-2). The BREQ-2 is a 19 item questionnaire that measures the stages of the self-determination continuum concerning motivation to exercise with a 5 point Likert scale (0=not true for me, 4=very true for me).	Immediately after the intervention.
3 months after intervention exercise motivation	The existence or not of behavioural change/motivation towards exercise will be assessed 3 months after the intervention by using the Behaviour Regulation in Physical Exercise Scale (BREQ-2). The BREQ-2 is a 19 item questionnaire that measures the stages of the self-determination continuum concerning motivation to exercise with a 5 point Likert scale (0=not true for me, 4=very true for me).	3 months after the intervention ending
6 months after intervention exercise motivation	The existence or not of behavioural change/motivation towards exercise will be assessed 6 months after the intervention by using the Behaviour Regulation in Physical Exercise Scale (BREQ-2). The BREQ-2 is a 19 item questionnaire that measures the stages of the self-determination continuum concerning motivation to exercise with a 5 point Likert scale (0=not true for me, 4=very true for me).	6 months after the intervention ending
Baseline kinesiophobia	Fear of movement will be measured before intervention by using the Tampa Kinesiophobia Scale. The scale is composed by 17 items that include two subscales, one measures activity avoidance and the other one somatic focus. The total score of the scale range from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia.	At baseline
After intervention kinesiophobia	Fear of movement will be measured after the intervention by using the Tampa Kinesiophobia Scale. The scale is composed of 17 items that include two subscales, one measures activity avoidance and the other one somatic focus. The total score of the scale range from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia.	Immediately after the intervention.
3 months after intervention kinesiophobia	Fear of movement will be measured 3 months after the intervention by using the Tampa Kinesiophobia Scale. The scale is composed of 17 items that include two subscales, one measures activity avoidance and the other one somatic focus. The total score of the scale range from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia.	3 months after the intervention ending
6 months after intervention kinesiophobia	Fear of movement will be measured 6 months after the intervention by using the Tampa Kinesiophobia Scale. The scale is composed of 17 items that include two subscales, one measures activity avoidance and the other one somatic focus. The total score of the scale range from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia.	6 months after the intervention ending

Collaborators and Investigators

• Sponsor: GO fit Lab- Ingesport
• Collaborators: Marqués de Valdecilla University Hospital; Center for Sport Studies, Rey Juan Carlos University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 13, 2021
• Primary Completion (Anticipated): July 30, 2022
• Study Completion (Anticipated): September 20, 2022

Study Registration Dates

• First Submitted: August 24, 2021
• First Submitted That Met QC Criteria: September 1, 2021
• First Posted (Actual): September 10, 2021

Study Record Updates

• Last Update Posted (Actual): September 10, 2021
• Last Update Submitted That Met QC Criteria: September 1, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Physical exercise; Heart rate variability; Cardiovascular training; Strength training; Cancer patients; High-intensity training; Cardiotoxicity changes; Cancer-related side effects
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Wounds and Injuries; Breast Diseases; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Breast Neoplasms; Cardiotoxicity
• Other Study ID Numbers: CARDIEJERCAN

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No