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

Primary Purpose

Post-operative Breast Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
inspiratory muscle training
Sponsored by
University of Hail
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Breast Cancer

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    study group

    control group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    October 14, 2023
    Last Updated
    October 14, 2023
    Sponsor
    University of Hail
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06091696
    Brief Title
    The Effect of Inspiratory Muscle Training on Breast Cancer Patients Undergoing Surgery
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2023 (Anticipated)
    Primary Completion Date
    July 1, 2024 (Anticipated)
    Study Completion Date
    September 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Hail

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-operative Breast Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    a parallel model with 2 groups of study and control. with 3 and 6 months follow up.
    Masking
    InvestigatorOutcomes Assessor
    Masking Description
    Concealed allocation will be performed by a researcher who will not be involved in the treatment of assessment. Permuted blocks will be used to ensure an equal 1:1 allocation ratio. Due to the nature of the study, the assessor and the data analyzer will be blindfolded (double-blinded)
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    study group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    control group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    inspiratory muscle training
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Inspiratory muscle strength by Maximal inspiratory pressure MIP
    Description
    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
    Time Frame
    at baseline
    Title
    Inspiratory muscle strength by Maximal inspiratory pressure MIP
    Description
    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
    Time Frame
    after the end of the treatment (after 8 weeks)
    Title
    Inspiratory muscle strength by Maximal inspiratory pressure MIP
    Description
    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
    Time Frame
    at follow up (3months after the end of the treatment)
    Title
    Functional exercise capacity evaluated by a 6-minute walk test (6MWT).
    Description
    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
    Time Frame
    baseline
    Title
    Functional exercise capacity evaluated by a 6-minute walk test (6MWT).
    Description
    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
    Time Frame
    after the end of the treatment (after 8 weeks)
    Title
    Functional exercise capacity evaluated by a 6-minute walk test (6MWT).
    Description
    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
    Time Frame
    at follow up (3months after the end of the treatment)
    Title
    Handgrip strength
    Description
    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
    Time Frame
    at baseline
    Title
    Handgrip strength
    Description
    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
    Time Frame
    after the end of the treatment (after 8 weeks)
    Title
    Handgrip strength
    Description
    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
    Time Frame
    at follow up (3months after the end of the treatment)
    Title
    Fatigue Assessment Scale (FAS)
    Description
    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
    Time Frame
    baseline
    Title
    Fatigue Assessment Scale (FAS)
    Description
    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
    Time Frame
    after the end of the treatment (after 8 weeks)
    Title
    Fatigue Assessment Scale (FAS)
    Description
    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
    Time Frame
    at follow up (3months after the end of the treatment)
    Title
    Perceived stress (Perceived Stress Scale pss 10)
    Description
    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
    Time Frame
    baseline
    Title
    Perceived stress (Perceived Stress Scale pss 10)
    Description
    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
    Time Frame
    after the end of the treatment (after 8 weeks)
    Title
    Perceived stress (Perceived Stress Scale pss 10)
    Description
    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
    Time Frame
    at follow up (3months after the end of the treatment)

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    females with past history of breast cancer and underwent surgical treatment
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    upon request from the funder with a reasonable need

    Learn more about this trial

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

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