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

Not Applicable

Active, not recruiting

• Conditions: Sarcopenia

• Registration Number: NCT05668975
• Lead Sponsor: Istanbul University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-12
• Study First Submitted: 2022-11-17
• Status Verified: 2022-12
• Study First Submitted QC: 2022-12-29
• Last Update Submitted: 2022-12-29
• Study First Posted: 2022-12-30
• Last Update Posted: 2022-12-30
• Primary Completion: 2023-01-15
• Study Completion: 2023-02-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Diaphragm Thickness Measurement at Quiet Breathing	Eight weeks	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).
Maximal Inspiratory Pressure	Eight weeks	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.
Diaphragm Thickness Measurement at Total Lung Capacity (TLC)	Eight weeks	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).
Diaphragm Elastography Measurement at Total Lung Capacity (TLC)	Eight weeks	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).
Diaphragm Elastography Measurement at Quiet Breathing	Eight weeks	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).
Exercise Capacity Measurement	Eight weeks	The exercise capacity of the participants will be evaluated with six-minute walk test (6MWT).
Diaphragm Thickness Measurement at Functional Residual Capacity (FRC)	Eight weeks	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).
Diaphragm Elastography Measurement at Functional Residual Capacity (FRC)	Eight weeks	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).

Secondary Outcome Measures

Name	Time	Method
Pulmonary Function Test [Peak Expiratory Flow Rate (PEFR)]	Eight weeks	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.
Pulmonary Function Test [Forced expiratory flow 25-75 (FEF25-75%)]	Eight weeks	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.
Assesment of Quality of Life	Eight weeks	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.
Pulmonary Function Test [Forced Vital Capacity (FVC)]	Eight weeks	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.
Pulmonary Function Test [Forced Expiratory Volume in the first second (FEV1)]	Eight weeks	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.

Trial Locations

Locations (1)

İstanbul Üniversitesi İstanbul Tıp Fakültesi Spor Hekimliği Anabilim Dalı; 🇹🇷 İstanbul, Turkey