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

Study Overview
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Brief Summary
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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 will be compared to the effect of traditional care alone on multiple outcome measures such as muscle strength, function, fatigue, and stress.

Detailed Description
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Saudi Arabia reported 24,485 new cases of cancer in 2018 with 10518 cancer deaths, and 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 methods of cancer treatment, 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.

Official Title
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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

Conditions
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Post-operative Breast Cancer

Intervention / Treatment
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* Other: inspiratory muscle training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-operative Breast cancer females 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 given by the physician

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a parallel model with 2 groups of study and control. with 3 and 6 months follow up.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>Inspiratory muscle training will be conducted 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. Patients will start training with a MIP of 40%. The intensity of training will be adjusted every week based on MIP measurement. | Other: inspiratory muscle training<br>* 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.<br>|
| Active Comparator: control group<br>Warm-up and cool-down periods of 5 minutes each in addition to light aerobic activity will be performed by patients in both groups. Aerobic exercise training will be done through selected activities for 30 minutes /3 times per week for 8 weeks. | Other: inspiratory muscle training<br>* 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.<br>|

What is the study measuring?
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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) | 
| 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 (3months 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 | 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) | 
| 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 (3months 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 pro-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 pro-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 pro-and supination while performing the test. Both sides will be tested three times and the maximal value will be retained | at follow up (3months after the end of the treatment) | 
| 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 | 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 | 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 | at follow up (3months 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 | 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) | 
| 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 (3months after the end of the treatment) |