Geriatric IndividualsNCT06398704
Investigation of Inspiratory Muscle Strength and Cardiorespiratory Fitness in Sarcopenic Individuals
An observational study of Geriatric Individuals, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to examine the effects of sarcopenia and dynapenia on inspiratory muscle strength and cardiorespiratory fitness in geriatric individuals. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Geriatric Individuals
- What is being tested?
- Standart of care
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2024to 30 Jun 2024
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Geriatric Individuals
Who may be able to join
- Getting a score between 24 and 30 on the Mini Mental State Assessment
- Ability to stand without assistance for at least 90 seconds
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Geriatric Individuals
- Being tested
- Standart of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standart of careOther
No additional intervention was made. An evaluation was made.
| Study group | Role | What they receive |
|---|---|---|
| Sarcopenia Group | Individuals with sarcopenia according to the ISarcoPRM algorithm using the STAR method and Hand-grip Receives: Other: Standart of care | |
| Dinapenia Group | Individuals with dynapenia according to the ISarcoPRM algorithm using the STAR method and Hand-grip Receives: Other: Standart of care | |
| Non-sarcopenia Group | Individuals with non-sarcopenia according to the ISarcoPRM algorithm using the STAR method and Hand-grip Receives: Other: Standart of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonography Evaluation
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.
Measured: Baseline
Evaluation of Inspiratory Muscle Strength
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.
Measured: Baseline
2 Minute Step Test:
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2024
- Study start30 Apr 2024
- Primary completion20 Jun 2024
- Study completion30 Jun 2024
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 Geriatric IndividualsStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suleyman Korkusuz, Hacettepe University
- Investigators
- Süleyman Korkusuz, PhD, Principal investigator, Atılım UniversityÖzlem Yürük, Prof.Dr, Study chair, Baskent UniversityBüşra Seçkinoğulları Korkusuz, MSc, Study chair, Hacettepe UniversityFerdi Yavuz, Assoc.Prof., Study chair, European University of LefkeHülya Arıkan, Prof.Dr., Study chair, Atılım University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06398704
- Sponsor's protocol ID
- E-59394181-604.01-83836
- Status last verified
- Sep 2024
- First submitted
- 28 Apr 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30272099Sawaya 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.
PubMed 35194529Kara 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.
PubMed 34121127Kara 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.
PubMed 32941253
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effects of Sarcopenia and Dynapenia on Inspiratory Muscle Strength and Cardiorespiratory Fitness in Geriatric Individuals
- ClinicalTrials.gov ID
- NCT06398704
- Acronym / sponsor ID
- E-59394181-604.01-83836
- Conditions
- Geriatric Individuals
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 3 May 2024 (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.
The aim of our study is to examine the effects of sarcopenia and dynapenia on inspiratory muscle strength and cardiorespiratory fitness in geriatric individuals.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sarcopenia Group | – | Other: Standart of careIndividuals with sarcopenia according to the ISarcoPRM algorithm using the STAR method and Hand-grip |
| Dinapenia Group | – | Other: Standart of careIndividuals with dynapenia according to the ISarcoPRM algorithm using the STAR method and Hand-grip |
| Non-sarcopenia Group | – | Other: Standart of careIndividuals with non-sarcopenia according to the ISarcoPRM algorithm using the STAR method and Hand-grip |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Geriatric Individuals
Key inclusion criteria (2 listed)
- Getting a score between 24 and 30 on the Mini Mental State Assessment
- Ability to stand without assistance for at least 90 seconds
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Standart of careNo additional intervention was made. An evaluation was made. | Other | Dinapenia Group, Non-sarcopenia Group, Sarcopenia Group |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- 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 35194529Sawaya 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.
- Background: PubMed 34121127Kara 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.
- Background: PubMed 32941253Kara 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.
- Individual participant dataSharing planned: No
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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.
Süleyman Korkusuz, PhD principal investigator
Atılım University
Özlem Yürük, Prof.Dr study chair
Baskent University
Büşra Seçkinoğulları Korkusuz, MSc study chair
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Geriatric Individuals, run by Hacettepe 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 4 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: finished, as of the sponsor's last update on 27 Sep 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Ultrasonography Evaluation (time frame: Baseline). The study lists 3 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 NCT06398704, 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 27 Sep 2024.