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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05668975
• Other study ID #: ErenOzdogan-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 12, 2022
• Est. completion date: February 5, 2023

Study information

• Verified date: December 2022
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: February 5, 2023
• Est. primary completion date: January 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Aspiration
• Sarcopenia

Intervention

Device:
• Inspiratory Muscle Training
A mechanical pressure threshold loading device (POWERbreathe, POWERbreathe International Ltd, UK) will be used for the training.

Locations

Country	Name	City	State
Turkey	Istanbul Üniversitesi Istanbul Tip Fakültesi Spor Hekimligi Anabilim Dali	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169. Erratum In: Age Ageing. 2019 Jul 1;48(4):601. — View Citation

Deniz O, Coteli S, Karatoprak NB, Pence MC, Varan HD, Kizilarslanoglu MC, Oktar SO, Goker B. Diaphragmatic muscle thickness in older people with and without sarcopenia. Aging Clin Exp Res. 2021 Mar;33(3):573-580. doi: 10.1007/s40520-020-01565-5. Epub 2020 May 13. — View Citation

Ohara DG, Pegorari MS, Oliveira Dos Santos NL, de Fatima Ribeiro Silva C, Monteiro RL, Matos AP, Jamami M. Respiratory Muscle Strength as a Discriminator of Sarcopenia in Community-Dwelling Elderly: A Cross-Sectional Study. J Nutr Health Aging. 2018;22(8):952-958. doi: 10.1007/s12603-018-1079-4. — View Citation

Souza H, Rocha T, Pessoa M, Rattes C, Brandao D, Fregonezi G, Campos S, Aliverti A, Dornelas A. Effects of inspiratory muscle training in elderly women on respiratory muscle strength, diaphragm thickness and mobility. J Gerontol A Biol Sci Med Sci. 2014 Dec;69(12):1545-53. doi: 10.1093/gerona/glu182. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Exercise Capacity Measurement	The exercise capacity of the participants will be evaluated with six-minute walk test (6MWT).	Eight weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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