- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06398704
Investigation of Inspiratory Muscle Strength and Cardiorespiratory Fitness in Sarcopenic Individuals
September 25, 2024 updated by: Suleyman Korkusuz, Hacettepe University
Investigation of the Effects of Sarcopenia and Dynapenia on Inspiratory Muscle Strength and Cardiorespiratory Fitness in Geriatric Individuals
The aim of our study is to examine the effects of sarcopenia and dynapenia on inspiratory muscle strength and cardiorespiratory fitness in geriatric individuals.
Study Overview
Detailed Description
Within the scope of the study, anterior thigh thicknesses of geriatric individuals will be evaluated by ultrasonography and individuals will be divided into 3 groups as dynapenic, sarcopenic and normal according to the ISarcoPRM algorithm, using the STAR method and Hand-grip.
The Powerbreathe K5 device will be used to evaluate the inspiratory muscle strength of geriatric individuals in both groups, and the 2-minute step test will be used to evaluate cardiorespiratory fitness.
The study will be carried out with 100 geriatric individuals.
As a result of the study, first the inspiratory muscle strength and cardiorespiratory fitness of sarcopenic, dynapenic and non-sarcopenic groups will be compared.
Afterwards, the relationship between anterior thigh thickness and inspiratory muscle strength of all geriatric individuals participating in the study will be examined.
Study Type
Observational
Enrollment (Actual)
75
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ankara, Turkey
- Atılım University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Geriatric Individuals
Description
Inclusion Criteria:
- Getting a score between 24 and 30 on the Mini Mental State Assessment
- Ability to stand without assistance for at least 90 seconds
Exclusion Criteria:
- Inability to communicate verbally
- Using a walking aid
- Older adults with severe visual impairment, neurological disorders, and/or congestive heart failure
- Older adults for whom exercise is not recommended
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Sarcopenia Group
Individuals with sarcopenia according to the ISarcoPRM algorithm using the STAR method and Hand-grip
|
No additional intervention was made.
An evaluation was made.
|
|
Dinapenia Group
Individuals with dynapenia according to the ISarcoPRM algorithm using the STAR method and Hand-grip
|
No additional intervention was made.
An evaluation was made.
|
|
Non-sarcopenia Group
Individuals with non-sarcopenia according to the ISarcoPRM algorithm using the STAR method and Hand-grip
|
No additional intervention was made.
An evaluation was made.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ultrasonography Evaluation
Time Frame: Baseline
|
Anterior thigh muscle thickness will be measured to evaluate sarcopenia.
The obtained value will be divided by the Body Mass Index.
This evaluation method is referred to in the literature as the Sonographic T-high Adjustment Rate (STAR) method.
Ultrasonographic measurements will be made by a physician with at least 10 years of experience in this field using linear probes.
|
Baseline
|
|
Evaluation of Inspiratory Muscle Strength
Time Frame: Baseline
|
Powerbreathe K5 device was used to evaluate inspiratory muscle strength.
This device is a portable, easy-to-use, accessible and reliable device used for both education and treatment purposes and evaluation purposes.
|
Baseline
|
|
2 Minute Step Test:
Time Frame: Baseline
|
The purpose of this test is to elevate the knees to the midpoint between the patella and the anterior-superior iliac crest.
The 2 Minute Step Test is valid and reliable for assessing cardiorespiratory fitness in older adults.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Ferdi Yavuz, Assoc.Prof., European University of Lefke
- Principal Investigator: Süleyman Korkusuz, PhD, Atılım University
- Study Chair: Özlem Yürük, Prof.Dr, Baskent University
- Study Chair: Büşra Seçkinoğulları Korkusuz, MSc, Hacettepe University
- Study Chair: Hülya Arıkan, Prof.Dr., Atılım University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kara M, Kaymak B, Ata AM, Ozkal O, Kara O, Baki A, Sengul Aycicek G, Topuz S, Karahan S, Soylu AR, Cakir B, Halil M, Ozcakar L. STAR-Sonographic Thigh Adjustment Ratio: A Golden Formula for the Diagnosis of Sarcopenia. Am J Phys Med Rehabil. 2020 Oct;99(10):902-908. doi: 10.1097/PHM.0000000000001439.
- Kara M, Kaymak B, Frontera W, Ata AM, Ricci V, Ekiz T, Chang KV, Han DS, Michail X, Quittan M, Lim JY, Bean JF, Franchignoni F, Ozcakar L. Diagnosing sarcopenia: Functional perspectives and a new algorithm from the ISarcoPRM. J Rehabil Med. 2021 Jun 21;53(6):jrm00209. doi: 10.2340/16501977-2851.
- 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.
- Sawaya Y, Shiba T, Ishizaka M, Hirose T, Sato R, Kubo A, Urano T. Sarcopenia is not associated with inspiratory muscle strength but with expiratory muscle strength among older adults requiring long-term care/support. PeerJ. 2022 Feb 17;10:e12958. doi: 10.7717/peerj.12958. eCollection 2022.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 30, 2024
Primary Completion (Actual)
June 20, 2024
Study Completion (Actual)
June 30, 2024
Study Registration Dates
First Submitted
April 28, 2024
First Submitted That Met QC Criteria
May 1, 2024
First Posted (Actual)
May 3, 2024
Study Record Updates
Last Update Posted (Actual)
September 27, 2024
Last Update Submitted That Met QC Criteria
September 25, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-59394181-604.01-83836
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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