SarcopeniaNCT05668975
The Effects of Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Strength and Exercise Capacity in Individuals With Sarcopenia
A study testing Inspiratory Muscle Training in people with Sarcopenia, run by Istanbul University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Inspiratory Muscle Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Nov 2022to 5 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Üniversitesi İstanbul Tıp Fakültesi Spor Hekimliği Anabilim Dalı
Istanbul
About this study
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.
- Conditions
- Sarcopenia
- Being tested
- Inspiratory Muscle Training
- Keywords
- Inspiratory Muscle Training, Diaphragm Thickness, Respiratory Sarcopenia, Sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle TrainingDevice
A mechanical pressure threshold loading device (POWERbreathe, POWERbreathe International Ltd, UK) will be used for the training.
| Study group | Role | What they receive |
|---|---|---|
| Training Group | Experimental | 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. Receives: Device: Inspiratory Muscle Training |
| Sham Group | Sham comparator | 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. Receives: Device: Inspiratory Muscle Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Eight weeks
Exercise Capacity Measurement
The exercise capacity of the participants will be evaluated with six-minute walk test (6MWT).
Measured: Eight weeks
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start12 Nov 2022
- Primary completion15 Jan 2023 (estimated)
- Study completion5 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eren Özdoğan, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668975
- Sponsor's protocol ID
- ErenOzdogan-001
- Status last verified
- Dec 2022
- First submitted
- 17 Nov 2022
- Last updated
- 30 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30312372Ohara 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.
PubMed 30272099Deniz 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.
PubMed 32406014Souza 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.
PubMed 25395284
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Inspiratory Muscle Training on Diaphragm Thickness, Inspiratory Muscle Strength and Exercise Capacity in Individuals With Sarcopenia
- ClinicalTrials.gov ID
- NCT05668975
- Acronym / sponsor ID
- ErenOzdogan-001
- Conditions
- Sarcopenia
- Keywords
- Inspiratory Muscle Training, Diaphragm Thickness, Respiratory Sarcopenia, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 12 Nov 2022 (actual)
- Primary completion
- 15 Jan 2023 (estimated)
- Study completion
- 5 Feb 2023 (estimated)
- First posted
- 30 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Group | Experimental | Device: Inspiratory Muscle TrainingIndividuals 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. |
| Sham Group | Sham comparator | Device: Inspiratory Muscle TrainingIndividuals 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory Muscle TrainingA mechanical pressure threshold loading device (POWERbreathe, POWERbreathe International Ltd, UK) will be used for the training. | Device | Sham Group, Training Group |
Primary outcome
Maximal Inspiratory Pressure
Time frame: 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 Quiet Breathing
Time frame: 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).
Diaphragm Thickness Measurement at Total Lung Capacity (TLC)
Time frame: 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 Thickness Measurement at Functional Residual Capacity (FRC)
Time frame: 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 Quiet Breathing
Time frame: 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 Total Lung Capacity (TLC)
Time frame: 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 Functional Residual Capacity (FRC)
Time frame: 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
Time frame: Eight weeks
The exercise capacity of the participants will be evaluated with six-minute walk test (6MWT).
5 secondary outcomes
Pulmonary Function Test [Forced Vital Capacity (FVC)]
Time frame: Eight weeks
Pulmonary Function Test [Forced Expiratory Volume in the first second (FEV1)]
Time frame: Eight weeks
Pulmonary Function Test [Peak Expiratory Flow Rate (PEFR)]
Time frame: Eight weeks
Pulmonary Function Test [Forced expiratory flow 25-75 (FEF25-75%)]
Time frame: Eight weeks
Assesment of Quality of Life
Time frame: Eight weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2022.
- Background: PubMed 30312372Cruz-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.
- Background: PubMed 30272099Ohara 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.
- Background: PubMed 32406014Deniz 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.
- Background: PubMed 25395284Souza 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training in people with Sarcopenia, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Inspiratory Pressure (time frame: Eight weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05668975, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2022.