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

Primary Purpose

Sarcopenia

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Inspiratory Muscle Training
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sarcopenia focused on measuring Inspiratory Muscle Training, Diaphragm Thickness, Respiratory Sarcopenia, Sarcopenia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • İstanbul Üniversitesi İstanbul Tıp Fakültesi Spor Hekimliği Anabilim Dalı

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Training Group

Sham Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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).
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).
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).
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).
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).
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).
Exercise Capacity Measurement
The exercise capacity of the participants will be evaluated with six-minute walk test (6MWT).

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
November 17, 2022
Last Updated
December 29, 2022
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT05668975
Brief Title
The Effects of Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Strength and Exercise Capacity in Individuals With Sarcopenia
Official Title
The Effects of Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Strength and Exercise Capacity in Individuals With Sarcopenia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 12, 2022 (Actual)
Primary Completion Date
January 15, 2023 (Anticipated)
Study Completion Date
February 5, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
Inspiratory Muscle Training, Diaphragm Thickness, Respiratory Sarcopenia, Sarcopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Training Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Inspiratory Muscle Training
Intervention Description
A mechanical pressure threshold loading device (POWERbreathe, POWERbreathe International Ltd, UK) will be used for the training.
Primary Outcome Measure Information:
Title
Maximal Inspiratory Pressure
Description
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.
Time Frame
Eight weeks
Title
Diaphragm Thickness Measurement at Quiet Breathing
Description
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).
Time Frame
Eight weeks
Title
Diaphragm Thickness Measurement at Total Lung Capacity (TLC)
Description
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).
Time Frame
Eight weeks
Title
Diaphragm Thickness Measurement at Functional Residual Capacity (FRC)
Description
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).
Time Frame
Eight weeks
Title
Diaphragm Elastography Measurement at Quiet Breathing
Description
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).
Time Frame
Eight weeks
Title
Diaphragm Elastography Measurement at Total Lung Capacity (TLC)
Description
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).
Time Frame
Eight weeks
Title
Diaphragm Elastography Measurement at Functional Residual Capacity (FRC)
Description
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).
Time Frame
Eight weeks
Title
Exercise Capacity Measurement
Description
The exercise capacity of the participants will be evaluated with six-minute walk test (6MWT).
Time Frame
Eight weeks
Secondary Outcome Measure Information:
Title
Pulmonary Function Test [Forced Vital Capacity (FVC)]
Description
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.
Time Frame
Eight weeks
Title
Pulmonary Function Test [Forced Expiratory Volume in the first second (FEV1)]
Description
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.
Time Frame
Eight weeks
Title
Pulmonary Function Test [Peak Expiratory Flow Rate (PEFR)]
Description
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.
Time Frame
Eight weeks
Title
Pulmonary Function Test [Forced expiratory flow 25-75 (FEF25-75%)]
Description
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.
Time Frame
Eight weeks
Title
Assesment of Quality of Life
Description
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.
Time Frame
Eight weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
İstanbul Üniversitesi İstanbul Tıp Fakültesi Spor Hekimliği Anabilim Dalı
City
İstanbul
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
30312372
Citation
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.
Results Reference
background
PubMed Identifier
30272099
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.
Results Reference
background
PubMed Identifier
32406014
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.
Results Reference
background
PubMed Identifier
25395284
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.
Results Reference
background

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

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