The Effect of Inspiratory Muscle Training on Breast Cancer Patients Undergoing Surgery

The Effect of Inspiratory Muscle Training on Respiratory Muscle Strength, Functional Capacity, Fatigue, and Stress in Breast Cancer Patients Undergoing Surgery: A Randomized Controlled Trial

This study will address the female patients who are exposed to surgery after breast cancer. strength training for the inspiratory muscles will be applied in addition to the traditional care including physical therapy that will be compared to the effect of the traditional care alone on multiple outcome measures such as muscle strength, function, fatigue, and stress.

Study Overview

• Status: Completed
• Conditions: Post-operative Breast Cancer
• Intervention / Treatment: Other: inspiratory muscle training; Other: Aerobic exercises

Detailed Description

Saudi Arabia reported 24,485 new cases of cancer in 2018 with 10518 cancer deaths. There were genetic, hormonal, lifestyle, obesity, and environmental risk factors associated with different cancer types.

Many of the side effects of cancer and its treatments are burdensome and significantly impact the quality-of-life quality. Exercise before, during, and after cancer treatment provides numerous beneficial outcomes such as improving physical capacity, muscle power, and psychological status. Exercise is a valuable therapeutic tool for lowering acute, long-term, and late adverse effects of cancer.

For breast cancer patients, physiotherapy is a crucial component of treatment. The physical therapy exercise program helps patients regain fitness, reduce pain, and reduce side effects caused by different cancer treatment methods. Respiratory physiotherapy is a useful procedure for maintaining and improving functional capacity, quality of life, and post-treatment sequelae after breast cancer management, which is a combination of strategies aimed at preventing, treating, and stabilizing cardiorespiratory disorders in adults.

This study aimed to evaluate the effectiveness of inspiratory muscle training in post-surgical breast cancer survivors.

• Study Type: Interventional
• Enrollment (Actual): 47
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Hail, Saudi Arabia, 3994
    • Hisham Hussein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Post-operative breast cancer female patients
• Age ≥40 years
• All patients with Eastern Cooperative Oncology Group performance status score ≤ 2
• Having to undergo primary treatment with surgery

Exclusion Criteria:

• Severe anemia (Hb ≤ 8 g/dL)
• Presence of underlying chronic cardiac or respiratory disease
• severe infection, neurologic or muscular diseases prohibiting physical activity
• uncontrolled and/or extensive brain metastases, or bone metastases that were assessed to pose a risk of pathological fractures from exercising
• Contraindications descriped by the physician

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group; Inspiratory muscle training will be conducted using a pressure threshold loading device (Threshold Inspiratory Muscle Training, Respironics, Pittsburg, PA, USA). Using a spring-loaded one-way valve, this device provides air flow-independent resistance to inspiration at a detectable intensity. Patients will start training with a maximum inspiratory pressure (MIP) of 40%. The training intensity will be adjusted every week based on the MIP measurement.	Other: inspiratory muscle training; inspiratory muscle training will be done by using a pressure threshold loading device (Threshold Inspiratory Muscle Training, Respironics, Pittsburg, PA, USA). By using a spring-loaded one-way valve, this device provides air flow-independent resistance to inspiration at a detectable intensity.; Other: Aerobic exercises; Exercise training sessions under the supervision of an experienced physiotherapist were conducted for 30 minutes, 3 times per week, with intensity ranging between 13 and 15 on the rated perceived exertion scale (RPE).; Other Names: exercises
Active Comparator: control group; 5 minutes of warming up and a similar time for cooling down in addition to light aerobic activity will be performed by the patients in both groups. Aerobic exercise training will be done through selected activities for 30 minutes /3 times per week for 8 weeks.	Other: Aerobic exercises; Exercise training sessions under the supervision of an experienced physiotherapist were conducted for 30 minutes, 3 times per week, with intensity ranging between 13 and 15 on the rated perceived exertion scale (RPE).; Other Names: exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inspiratory muscle strength by Maximal inspiratory pressure MIP	Measurement of MIP will be performed using a portable electronic respiratory mouth pressure meter device (Micro RPM, Micro Medical Ltd, Kent, UK), which is a reliable and valid tool for the measurement of MIP. The MIP will be measured by deep inspiration through the mouthpiece only from the residual volume after maximal expiration. Leaning forward will not allowed during testing as it can overestimate the measurement values	at baseline
Inspiratory muscle strength by Maximal inspiratory pressure MIP	Measurement of MIP will be performed using a portable electronic respiratory mouth pressure meter device (Micro RPM, Micro Medical Ltd, Kent, UK), which is a reliable and valid tool for the measurement of MIP. The MIP will be measured by deep inspiration through the mouthpiece only from the residual volume after maximal expiration. Leaning forward will not allowed during testing as it can overestimate the measurement values	after the end of the treatment (after 8 weeks)
Functional exercise capacity evaluated by a 6-minute walk test (6MWT).	The 6-minute walk test had been clinically validated, it is used to determine the effects of therapeutic interventions and prognosis. The participants will be instructed to walk as far as possible without running in six minutes, the maximum distance covered at the end of the test will be recorded	baseline
Functional exercise capacity evaluated by a 6-minute walk test (6MWT).	The 6-minute walk test had been clinically validated, it is used to determine the effects of therapeutic interventions and prognosis. The participants will be instructed to walk as far as possible without running in six minutes, the maximum distance covered at the end of the test will be recorded	after the end of the treatment (after 8 weeks)
Fatigue Assessment Scale (FAS)	The FAS is a 10-item validated and reliable scale that will be used for evaluating symptoms of chronic fatigue.it is a self-report, paper-and-pencil measure requiring approximately 2 min for administration. Scoring each item of the FAS is answered using a five-point, Likert-type scale ranging from 1 ("never") to 5 ("always"). Items 4 and 10 are reverse-scored. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest	after the end of the treatment (after 8 weeks)
Perceived stress (Perceived Stress Scale pss 10)	Is the most widely used psychological instrument for measuring the perception of stress? It is a measure of the degree to which situations in one's life are appraised as stressful. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived. Stress, Scores ranging from 0-13 would be considered low stress, and Scores ranging from 14-26 would be considered moderate stress	baseline
Perceived stress (Perceived Stress Scale pss 10)	Is the most widely used psychological instrument for measuring the perception of stress? It is a measure of the degree to which situations in one's life are appraised as stressful. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived. Stress, Scores ranging from 0-13 would be considered low stress, and Scores ranging from 14-26 would be considered moderate stress	after the end of the treatment (after 8 weeks)
Inspiratory muscle strength by Maximal inspiratory pressure MIP	Measurement of MIP will be performed using a portable electronic respiratory mouth pressure meter device (Micro RPM, Micro Medical Ltd, Kent, UK), which is a reliable and valid tool for the measurement of MIP. The MIP will be measured by deep inspiration through the mouthpiece only from the residual volume after maximal expiration. Leaning forward will not allowed during testing as it can overestimate the measurement values	at follow up (3 months after the end of the treatment)
Functional exercise capacity evaluated by a 6-minute walk test (6MWT).	The 6-minute walk test had been clinically validated, it is used to determine the effects of therapeutic interventions and prognosis. The participants will be instructed to walk as far as possible without running in six minutes, the maximum distance covered at the end of the test will be recorded	at follow up (3 months after the end of the treatment)
Handgrip strength	Handgrip strength will be measured using handheld dynamometry. Patients have to keep the elbow of the tested side in 90 degrees of flexion and a neutral position of pronation and supination while performing the test. Both sides will be tested three times and the maximal value will be retained	at baseline
Handgrip strength	Handgrip strength will be measured using handheld dynamometry. Patients have to keep the elbow of the tested side in 90 degrees of flexion and a neutral position of pronation and supination while performing the test. Both sides will be tested three times and the maximal value will be retained	after the end of the treatment (after 8 weeks)
Handgrip strength	Handgrip strength will be measured using handheld dynamometry. Patients have to keep the elbow of the tested side in 90 degrees of flexion and a neutral position of pronation and supination while performing the test. Both sides will be tested three times and the maximal value will be retained	at follow up (3 months after the end of the treatment)
Fatigue Assessment Scale (FAS)	The Fatigue assessment scale (FAS) is a 10-item validated and reliable scale that will be used for evaluating symptoms of chronic fatigue.it is a self-report, paper-and-pencil measure requiring approximately 2 min for administration. Scoring each item of the FAS is answered using a five-point, Likert-type scale ranging from 1 ("never") to 5 ("always"). Items 4 and 10 are reverse-scored. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest	baseline
Fatigue Assessment Scale (FAS)	The FAS is a 10-item validated and reliable scale that will be used for evaluating symptoms of chronic fatigue.it is a self-report, paper-and-pencil measure requiring approximately 2 min for administration. Scoring each item of the FAS is answered using a five-point, Likert-type scale ranging from 1 ("never") to 5 ("always"). Items 4 and 10 are reverse-scored. Total scores can range from 10, indicating the lowest level of fatigue, to 50, denoting the highest	at follow up (3 months after the end of the treatment)
Perceived stress (Perceived Stress Scale pss 10)	Is the most widely used psychological instrument for measuring the perception of stress? It is a measure of the degree to which situations in one's life are appraised as stressful. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived. Stress, Scores ranging from 0-13 would be considered low stress, and Scores ranging from 14-26 would be considered moderate stress	at follow up (3 months after the end of the treatment)

Collaborators and Investigators

• Sponsor: University of Hail

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2023
• Primary Completion (Actual): January 1, 2024
• Study Completion (Actual): February 1, 2024

Study Registration Dates

• First Submitted: October 14, 2023
• First Submitted That Met QC Criteria: October 14, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

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: H-2023-367

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: upon request from the funder with a reasonable need

Drug and device information, study documents

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