The Effects of Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Strength and Exercise Capacity in Individuals With Sarcopenia

Study Overview
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Brief Summary
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Sarcopenia, according to EWGSOP2(European Working Group on Sarcopenia in Older People-2019), is a progressive and generalised skeletal muscle disorder that is associated with increased likelihood of adverse outcomes including falls, fractures, physical disability, and mortality. Changes in muscle strength and muscle mass that occur with aging are not only limited to the skeletal muscles surrounding the axial and appendicular skeleton, but also occur in the respiratory muscles. With aging, respiratory muscle strength decreases, muscle mass decreases, and respiratory functions decline. In sarcopenic individuals; maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP) and diaphragm muscle thickness values were found to be significantly lower. It is known that exercise is the most effective and valid way to treat sarcopenia. Considering the positive effects of IMT (Inspiratory Muscle Training) on both respiratory and physical parameters in the elderly population, we think that these changes can also be observed in sarcopenic individuals. Therefore, the aim of this study is to investigate the effects of inspiratory muscle training on diaphragm thickness, inspiratory muscle strength, and exercise capacity in sarcopenic individuals.

Official Title
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The Effects of Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Strength and Exercise Capacity in Individuals With Sarcopenia

Conditions
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Sarcopenia

Intervention / Treatment
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* Device: Inspiratory Muscle Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People who are diagnosed with confirmed sarcopenia or severe sarcopenia according to EWGSOP2 (European Working Group on Sarcopenia in Older People-2019) Getting a score of 24 or higher on the mini-mental state test Exclusion Criteria: Presence of chronic lung and/or cardiovascular disease Presence of severe orthopedic diseases which may affect participants' mobility Presence of uncontrollable hypertension and/or diabetes.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training Group<br>Individuals with sarcopenia in this group will perform three sets of 10 repetitions, with 1-minute of rest allocated between sets, twice daily, 5 days per week for eight weeks. The first session will be performed supervised in a clinic, other sessions will be performed at home. Telephone contact will be held twice a week to ensure the completion of training and clarify any doubts. Training intensity will be set at 60% of the maximum inspiratory pressure for the first week then will be set at %70 of the maximum inspiratory pressure for the second week. After the second week, training intensity will be increased as much as participants tolerated at the start of each week. | Device: Inspiratory Muscle Training<br>* A mechanical pressure threshold loading device (POWERbreathe, POWERbreathe International Ltd, UK) will be used for the training.<br>|
| Sham Comparator: Sham Group<br>Individuals with sarcopenia in this group will perform two sets of 10 repetitions, with 1-minute of rest allocated between sets, one time a day, 2 days per week for eight weeks. The first session will be performed supervised in a clinic, other sessions will be performed at home. Training intensity will be set at 10 cm H₂O for all training sessions. | Device: Inspiratory Muscle Training<br>* A mechanical pressure threshold loading device (POWERbreathe, POWERbreathe International Ltd, UK) will be used for the training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal Inspiratory Pressure | Maximal inspiratory pressure (MIP) will be measured using an electronic mouth pressure device (Micro RPM). At least 3 repetitions will be performed and the measurement will be repeated until there is less than a 5% difference between the best and the second-best measurement. | Eight weeks | 
| Diaphragm Thickness Measurement at Quiet Breathing | Diaphragm thickness measurement will be performed with the Toshiba Aplio 500 ultrasound device at Istanbul University, Istanbul Faculty of Medicine, Department of Sports Medicine. Diaphragm thickness will be measured as the vertical distance between the pleural and peritoneal layer at quiet breathing. Measurement will be performed on the right hemidiaphragm with the volunteer in the supine position. The measurement will be performed 3 times and the average value will be calculated. The value will be expressed in millimeters (mm). | Eight weeks | 
| Diaphragm Thickness Measurement at Total Lung Capacity (TLC) | Diaphragm thickness measurement will be performed with the Toshiba Aplio 500 ultrasound device at Istanbul University, Istanbul Faculty of Medicine, Department of Sports Medicine. Diaphragm thickness will be measured as the vertical distance between the pleural and peritoneal layer at Total Lung Capacity (TLC). Measurement will be performed on the right hemidiaphragm with the volunteer in the supine position. The measurement will be performed 3 times and the average value will be calculated. The value will be expressed in millimeters (mm). | Eight weeks | 
| Diaphragm Thickness Measurement at Functional Residual Capacity (FRC) | Diaphragm thickness measurement will be performed with the Toshiba Aplio 500 ultrasound device at Istanbul University, Istanbul Faculty of Medicine, Department of Sports Medicine. Diaphragm thickness will be measured as the vertical distance between the pleural and peritoneal layer at Functional Residual Capacity [FRC]. Measurement will be performed on the right hemidiaphragm with the volunteer in the supine position. The measurement will be performed 3 times and the average value will be calculated. The value will be expressed in millimeters (mm). | Eight weeks | 
| Diaphragm Elastography Measurement at Quiet Breathing | Diaphragm elastography measurement will be performed with the Toshiba Aplio 500 ultrasound device at Istanbul University, Istanbul Faculty of Medicine, Department of Sports Medicine. The measurement will be performed on the right hemidiaphragm with the volunteer in the supine position. The measurement will be performed 2 times and the average value will be calculated. The value will be expressed in kPa (kilopascal). | Eight weeks | 
| Diaphragm Elastography Measurement at Total Lung Capacity (TLC) | Diaphragm elastography measurement will be performed with the Toshiba Aplio 500 ultrasound device at Istanbul University, Istanbul Faculty of Medicine, Department of Sports Medicine. The measurement will be performed on the right hemidiaphragm with the volunteer in the supine position. The measurement will be performed 2 times and the average value will be calculated. The value will be expressed in kPa (kilopascal). | Eight weeks | 
| Diaphragm Elastography Measurement at Functional Residual Capacity (FRC) | Diaphragm elastography measurement will be performed with the Toshiba Aplio 500 ultrasound device at Istanbul University, Istanbul Faculty of Medicine, Department of Sports Medicine. The measurement will be performed on the right hemidiaphragm with the volunteer in the supine position. The measurement will be performed 2 times and the average value will be calculated. The value will be expressed in kPa (kilopascal). | Eight weeks | 
| Exercise Capacity Measurement | The exercise capacity of the participants will be evaluated with six-minute walk test (6MWT). | Eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Function Test [Forced Vital Capacity (FVC)] | The pulmonary function test [Forced Vital Capacity (FVC)] will be performed with Spirobank Mir (SN A23-048) / Winspro v.3.1.1 open circuit spirometer. | Eight weeks | 
| Pulmonary Function Test [Forced Expiratory Volume in the first second (FEV1)] | The pulmonary function test [Forced Expiratory Volume in the first second (FEV1)] will be performed with Spirobank Mir (SN A23-048) / Winspro v.3.1.1 open circuit spirometer. | Eight weeks | 
| Pulmonary Function Test [Peak Expiratory Flow Rate (PEFR)] | The pulmonary function test [Peak Expiratory Flow Rate (PEFR)] will be performed with Spirobank Mir (SN A23-048) / Winspro v.3.1.1 open circuit spirometer. | Eight weeks | 
| Pulmonary Function Test [Forced expiratory flow 25-75 (FEF25-75%)] | The pulmonary function test [Forced expiratory flow 25-75 (FEF25-75%)] will be performed with Spirobank Mir (SN A23-048) / Winspro v.3.1.1 open circuit spirometer. | Eight weeks | 
| Assesment of Quality of Life | Participants' quality of life will be assessed by the Sarcopenia and Quality of Life (SarQoL) questionnaire. The highest score is 100 and a higher score indicates a better level of quality of life. | Eight weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inspiratory Muscle Training, Diaphragm Thickness, Respiratory Sarcopenia, Sarcopenia