Physical Exercise for Breast Cancer Survivors: Face-to-face Versus Home-based (On4Rehab)

Pilot Study of Supervised Adapted Physical Exercise in Women With Breast Cancer After Treatment - Face-to-face Context vs Online Home Based

The present investigation is a pilot feasibility study that aims to compare a physical exercise intervention in a face-to-face context (considered state of the art) with a physical exercise intervention in a distance context (online), both supervised, in women, of legal age, physically inactive, breast cancer survivors after primary treatment with curative intent.

Before and after the intervention these women will have a physical and functional assessment, as well as a pre-trial cardiopulmonary exercise test, to check if there are safety conditions to participate and also to self tailor the exercise prescription.

The prescription follows the ACSM´s exercise guidelines for cancer survivors and will comprise a 8 week combined exercise training, 3 times per week, in which two of them will be supervised and the third session of the week (cardio session) won´t.

Chat´s and weekly personal messages, as well as education, will be used to promote retention and exercise adherence.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Combined exercise training

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Porto
    • Vila Nova De Gaia, Porto, Portugal, 4400
      • Centro Hospitalar Vila Nova de Gaia/Espinho

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Women
• Over legal age
• With diagnosis of breast carcinoma between stages 0 and IIIc
• ECOG 0 to 1
• Undergoing primary treatment with curative intent (surgery associated or not, with chemotherapy and / or adjuvant radiotherapy) for at least one month
• With follow-up on medical oncology consultation at CHVNG/E
• With consent of the attending oncologist for the practice of physical exercise
• Non-compliance with current physical activity guidelines recommended by the ACSM (moderate aerobic activity> = 150 min / week or vigorous> = 75 min / week and > = 2 strength training sessions / week)
• With cognitive capacity to understand the project proposal

Exclusion Criteria:

• Severe anaemia seen in the last 3 months (Hb <= 8g / dl) or moderate (Hb> 8 and <= 10 g / dl) symptomatic (sustained tachycardia, exertional dyspnea, chest pain or syncope),
• Uncontrolled arterial hypertension (HTN grade 3-4 (CTCAE v.5)) (SAD> = 160mmHg and / or DAD> = 100mmHg) and / or potentially fatal consequences (malignant HTN, transient or permanent neurological deficit or hypertensive crisis)
• Uncontrolled diabetes mellitus
• Known cardiac or respiratory pathology
• Any other contraindication given by the physiatrist and / or assistant surgeon

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Face-to-Face Group; This arm will have a 3 day per week face-to-face participant-tailored combined exercise program, with 2 supervised sessions and 1 non supervised aerobic session, for 8 weeks	Other: Combined exercise training; Before the intervention, these women will undergo an evaluation of cardiorespiratory fitness, functional fitness, psychological status and a physiatry assessment. A consent form is signed before the start. The physical exercise intervention was planned based on the recommendations of the American College of Sports Medicine for cancer survivors (ACSM 2019), with two supervised combined training sessions (mobility, aerobic training, strength and flexibility training) planned, and one unsupervised aerobic training session per week, interspersed with at least one rest day in between, for 8 weeks. The intensity will be individualized and defined based on the initial assessment. The structure of the training plan was based on the FITT-VP principles (frequency, intensity, time, type, volume and progression) recommended by the ACSM (2019).
Experimental: Home-Based Group; This arm will have a 3 day per week home-based participant-tailored combined exercise program, with 2 remotely supervised sessions (online) and 1 non supervised aerobic session, for 8 weeks	Other: Combined exercise training; Before the intervention, these women will undergo an evaluation of cardiorespiratory fitness, functional fitness, psychological status and a physiatry assessment. A consent form is signed before the start. The physical exercise intervention was planned based on the recommendations of the American College of Sports Medicine for cancer survivors (ACSM 2019), with two supervised combined training sessions (mobility, aerobic training, strength and flexibility training) planned, and one unsupervised aerobic training session per week, interspersed with at least one rest day in between, for 8 weeks. The intensity will be individualized and defined based on the initial assessment. The structure of the training plan was based on the FITT-VP principles (frequency, intensity, time, type, volume and progression) recommended by the ACSM (2019).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention rate	The percentage of included patients who ended the program	End of the intervention (week 9)
Adherence rate	Number of absences to the sessions and number of completed sessions	End of the intervention (week 9)
Training tolerance regarding the duration of the exercise prescription	Recording adherence to the exercise prescription duration, possible adjustments and their reasons	During all intervention sessions (24 sessions, 8 weeks)
Training tolerance regarding the intensity of the exercise prescription	Recording adherence to the exercise prescription intensity, possible adjustments and their reasons	During all intervention sessions (24 sessions, 8 weeks)
Training tolerance regarding the volume of the exercise prescription	Recording adherence to the exercise prescription volume, possible adjustments and their reasons	During all intervention sessions (24 sessions, 8 weeks)
Intervention Recruitment Rate	Number of invitations made versus accepted (invitation made by the assistant oncologist)	Beginning of the intervention (week 0)
Training safety	Recording symptoms and adverse effects	During all intervention sessions (24 sessions, 8 weeks)
Absence and dropout	Rate of absence from sessions and dropout of the program	End of the intervention (week 9)
Level of satisfaction	Questionnaire at the end of the intervention, from 1 to 5, where 1 is not satisfied and 5 is very satisfied	End of the intervention (week 9)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiopulmonary system fitness level and signs of disease assessment	Measurement of maximum VO2 by a cardiopulmonary exercise test and assessment of cardiopulmonary risk factors or disease	Beginning of the intervention (week 0)
Lower limb strength	30´´Sit to stand test (number of repetitions)	Beginning (week 0) and End of the intervention (week 9)
Upper limb strenght	Bilateral handgrip test with dynamometer (kg)	Beginning (week 0) and End of the intervention (week 9)
Lower limbs flexibility level	Sit and Reach test (cm)	Beginning (week 0) and End of the intervention (week 9)
Static balance	One Leg Stance test (time, s)	Beginning (week 0) and End of the intervention (week 9)
Dynamic balance and agility	8 Foot up and go test (time, s)	Beginning (week 0) and End of the intervention (week 9)
Assessment of aerobic capacity	6 Minute Walk Test	Beginning (week 0) and End of the intervention (week 9)
Safety of the intervention	Number of serious and less serious occurrences	During all intervention sessions (24 sessions, 8 weeks)
Body weight	Weight (Kg)	Beginning (week 0) and End of the intervention (week 9)
Body height	Height (m)	Beginning (week 0) and End of the intervention (week 9)
Body circumferences	Waist circumference (cm), hip circumference (cm), middle crural circumference (cm) and bicipital circumference (cm)	Beginning (week 0) and End of the intervention (week 9)
Individual's overall satisfaction with life and general sense of personal well-being	Questionnaire QLQ-C30	Beginning (week 0) and End of the intervention (week 9)
Individual's overall satisfaction with life and general sense of personal well-being, specific to breast cancer patient	Questionnaire QLQ-BR23	Beginning (week 0) and End of the intervention (week 9)
Adverse effects	Common Terminology Criteria for Adverse Effects, version 5, scale (presence of fatigue, osteoarticular and cardiac complaints, pain, neuropathy and lymphedema), ranging from 1 (mild, asymptomatic ou mild symptoms) to 5 (dead related to adverse event)	During all intervention sessions (24 sessions, 8 weeks)
Assessment of performance status	ECOG scale of performance status, in a scale ranging from 0 (fully active, able to carry same activities as before disease without new restrictions) to 5 (dead)	During all intervention sessions (24 sessions, 8 weeks)
Heart Function	Resting heart rate (bpm)	Beginning of the intervention (week 0)
Arterial disorder assessment	Systolic and diastolic blood pressure assessment (mm/hg)	Beginning of the intervention (week 0)
Physical activity and sedentary behaviors	Accelerometry	Beginning (week 0) and End of the intervention (week 9)
Subjective perception of effort	Borg scale of perceived exertion ranging from 6 (very, very light effort) to 20 (maximum exertion)	During all intervention sessions (24 sessions, 8 weeks)

Collaborators and Investigators

• Sponsor: Associacao de Investigacao de Cuidados de Suporte em Oncologia
• Collaborators: Universidad Europea de Madrid; Centro Hospitalar de Vila Nova de Gaia/Espinho; University Institute of Maia
• Investigators: Study Director: Sandra Martins, PhD, Universidade Europeia

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: July 4, 2021
• First Submitted That Met QC Criteria: October 7, 2021
• First Posted (Actual): October 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 27, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: On4Rehab Pilot Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All participant data will be available with the exception of personal information
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

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