The Association Between Sarcopenia and the Strength of Peripheral and Respiratory Muscles in Elderly IndividualsNCT06756399
The Association Between Sarcopenia and the Strength of Peripheral and Respiratory Muscles in Elderly Individuals
An observational study of The Association Between Sarcopenia and the Strength of Peripheral and Respiratory Muscles in Elderly Individuals and Cardiovascular Diseases, run by Biruni University.
Trial summary
Population aging is a significant global trend, with projections indicating that by 2050, 1 in 6 individuals worldwide will be over 65 years old, compared to 1 in 11 in 2019. In Turkey, the elderly population is expected to rise to 11.0% by 2025 and reach 25.6% by 2080. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- The Association Between Sarcopenia and the Strength of Peripheral and Respiratory Muscles in Elderly Individuals, Cardiovascular Diseases, Diabetes Mellitus
- What is being tested?
- Questionnare, hand grip and respiratory muscle strength
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2025to 24 Feb 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Older adult
Study population: The Çanakkale Municipality Golden Years Life Center.
Who may be able to join
- 65 years to 80 years (Older ),
- Standardised Mini Mental Test score ≥ 20,
- Volunteering to participate in the study study
- Registered at the Çanakkale Municipality Golden Years Life Center.
Who cannot join
- With with a history of respiratory disease or receiving treatment for respiratory disease
- With serious orthopedic diseases that may affect the measurements
- Diagnosed with dementia
- Smokers.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Relationship Between Sarcopenia and Peripheral and Respiratory Muscle Strength in Geriatric Individuals
Population aging is a significant global trend, with projections indicating that by 2050, 1 in 6 individuals worldwide will be over 65 years old, compared to 1 in 11 in 2019. In Turkey, the elderly population is expected to rise to 11.0% by 2025 and reach 25.6% by 2080. Sarcopenia, characterized by the progressive loss of skeletal muscle mass (SMM) and function due to aging, affects approximately 29% of older adults in community healthcare settings. It is associated with various pathophysiological processes, leading to negative health outcomes like falls and frailty.
The European Working Group on Sarcopenia in Older People (EWGSOP) established diagnostic criteria for sarcopenia based on muscle mass, strength, and physical performance in 2010, later revised in 2018 (EWGSOP2), emphasizing low muscle strength as the primary diagnostic criterion. The SARC-F questionnaire is recommended for confirming sarcopenia, with a score of ≥ 4 indicating the condition.
Read more
The concept of respiratory sarcopenia, introduced in 2021, refers to the loss of respiratory muscle mass and strength alongside general body sarcopenia, though measuring respiratory muscle mass can be complex. Respiratory muscle strength can be assessed through mouth pressure measurement, but a consensus on the methodology is still lacking.
Overall, there is insufficient research on the relationship between peripheral and respiratory muscle weakness and sarcopenia in the elderly. This study aims to explore this relationship further.
Read the detailed description
Population aging is a global phenomenon characterized by a significant and rapid increase in the elderly population over recent years. According to World Population Prospects 2019 (United Nations, 2019), by 2050, 1 in 6 people in the world will be over the age of 65, up from 1 in 11 in 2019. It is estimated that the elderly population rate in our country will be 11.0% in 2025, 12.9% in 2030, 16.3% in 2040, 22.6% in 2060 and 25.6% in 2080.
Sarcopenia is a progressive and characterized loss of skeletal muscle mass (SMM) and function associated with aging. Several prospective studies have reported that skeletal muscle mass decreases by 6% per decade after middle age. In community healthcare settings, the prevalence of sarcopenia has been reported to reach up to 29% among older adults. Sarcopenia is thought to involve a variety of pathophysiological processes, including denervation, mitochondrial dysfunction, inflammatory and hormonal changes that can lead to adverse health outcomes such as falls, functional decline, frailty, weakness, and death due to a decrease in lean body mass. The European Working Group on Sarcopenia in Older People (EWGSOP) proposed three diagnostic criteria for sarcopenia based on muscle mass, muscle strength, and physical performance in 2010. The EWGSOP proposed for sarcopenia three diagnostic criteria; low muscle mass (LMM) is defined by a SMM index of less than 8.90 kg/m2, low muscle strength (LMS) by hand-grip strength below 30 kg in men and 20 kg in women, and low physical performance (LPP) by gait speeds of less than 0.8 m/s. In 2018, The European Working Group on Sarcopenia in Older People 2 (EWGSOP2) revised the diagnostic criteria and established that low muscle strength is the primary parameter for the diagnosis of sarcopenia and the most reliable measure of muscle function. In clinical practice, when a patient shows symptoms or signs of sarcopenia (i.e. falls, feeling weak, walking slowly and difficulty getting up from a chair, or weight loss or muscle wasting), the EWGSOP2 is recommended to use the SARC-F questionnaire, which consists of five items: Strength, Assistance in walking, Rising from a chair, Climbing stairs, and Falls to confirm the diagnosis. A score of the SARC-F questionnaire ≥ 4 is considered sarcopenia.
The concept of respiratory sarcopenia was first proposed in 2021 and is defined as "General body sarcopenia and low respiratory muscle mass followed by low respiratory muscle strength and/or low respiratory function." Diagnosis of respiratory sarcopenia is made by assessing respiratory muscle mass and strength. However, measuring respiratory muscle mass can often be complex, requiring advanced diagnostic equipment or techniques such as ultrasound echography and computed tomography. Assessing respiratory muscle strength is easier because it can be measured by mouth pressure measurement; however, there is no consensus yet on the exact methodology.
Studies showing the relationship between peripheral muscle and respiratory muscle weakness and sarcopenia in the elderly population are insufficient. In our study, we aim to examine the relationship between sarcopenia and peripheral and respiratory muscle strength.
- Conditions
- The Association Between Sarcopenia and the Strength of Peripheral and Respiratory Muscles in Elderly Individuals, Cardiovascular Diseases, Diabetes Mellitus, Hypertension
- Being tested
- Questionnare, hand grip and respiratory muscle strength
- Keywords
- Muscle strength, respiratory muscle strength, sarcopenia ., Cardiovascular diseases, Diabetes Mellitus, Hypertension
- Medical subject headings
- Cardiovascular Diseases, Diabetes Mellitus, Hypertension, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnare, hand grip and respiratory muscle strengthOther
Upper extremity strength will be assessed using the Jamar hand dynamometer to measure hand grip strength. For lower extremity muscle strength, participants will undergo the five-repetition sit-to-stand test. Respiratory muscle strength, both inspiratory and expiratory, will be measured through mouth pressure assessments. Additionally, participants will complete a questionnaire addressing components related to sarcopenia diagnosis, including questions on strength, assistance with walking, rising from a chair, climbing stairs, and incidence of falls.
| Study group | Role | What they receive |
|---|---|---|
| Elderly Individuals | The study group was composed of volunteers aged 65-80 years. Receives: Other: Questionnare, hand grip and respiratory muscle strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sociodemographic data form
Socio-demographic data of individuals (name-surname, age, gender, height, weight, smoking, occupation, education) will be collected with the demographic data collection form created by the researchers. In the clinical information section, other diseases and medications used will berecorded.
Measured: baseline
Hand grip strength
Upper extremity strength will be measured by hand grip strenght with a Jamar hand dynamometer. Participants will be seated with the dynamometer in their dominant hand, elbows flexed at 90° and next to the body, and three consecutive measurements will be taken with a 1-minute interval between measurements. The highest value will be recorded.
Measured: baseline
The five-repetition sit-to-stand test
Lower extremity muscle strength will be evaluated. Participants will test to cross their arms on their chest and sit down and stand up on a chair once for trial purposes. After the trial performance, they will be asked to sit down and stand up on the chair as quickly as possible without stopping, and the time will be recorded after the fifth repetition
Measured: baseline
Measurements of respiratory muscle strength
Inspiratory and expiratory respiratory muscle strength will be evaluated by the mouth pressure measurement.
Measured: baseline
SARC-F questionnaire
Participants will be asked the questionnaire about strength, assistance in walking, rising from a chair, climbing stairs, and falls components. Each component will be scored between 0-2. The total scores will be recorded that ranged from 0 to 10.
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 Jan 2025
- Study start20 Jan 2025 (estimated)
- Primary completion10 Feb 2025 (estimated)
- Study completion24 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for The Association Between Sarcopenia and the Strength of Peripheral and Respiratory Muscles in Elderly IndividualsStudies of the same condition, open and under way.
- More trials run by Biruni 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Collaborators
- Çanakkale Onsekiz Mart University
- Responsible party
- Principal investigator, Buket AKINCI, Biruni University
- Investigators
- Buket Akıncı, Ass.Prof, Principal investigator, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756399
- Sponsor's protocol ID
- 202412
- Status last verified
- Jan 2025
- First submitted
- 22 Dec 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bahat G, Yilmaz O, Kilic C, Oren MM, Karan MA. Performance of SARC-F in Regard to Sarcopenia Definitions, Muscle Mass and Functional Measures. J Nutr Health Aging. 2018;22(8):898-903. doi: 10.1007/s12603-018-1067-8.
PubMed 30272090Bohannon RW. Five-repetition sit-to-stand test: usefulness for older patients in a home-care setting. Percept Mot Skills. 2011 Jun;112(3):803-6. doi: 10.2466/15.26.PMS.112.3.803-806.
PubMed 21853769Cho MR, Lee S, Song SK. A Review of Sarcopenia Pathophysiology, Diagnosis, Treatment and Future Direction. J Korean Med Sci. 2022 May 9;37(18):e146. doi: 10.3346/jkms.2022.37.e146.
PubMed 35535373Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun.
PubMed 30956204Malmstrom TK, Morley JE. SARC-F: a simple questionnaire to rapidly diagnose sarcopenia. J Am Med Dir Assoc. 2013 Aug;14(8):531-2. doi: 10.1016/j.jamda.2013.05.018. Epub 2013 Jun 25. No abstract available.
PubMed 23810110Ohara 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, Hirose T, Ishizaka M, Shiba T, Sato R, Kubo A, Urano T. Patterns of Changes in Respiratory Muscle Strength over 1 Year in Non-Sarcopenia, Sarcopenia, and Severe Sarcopenia. Int J Environ Res Public Health. 2022 Dec 9;19(24):16571. doi: 10.3390/ijerph192416571.
PubMed 36554450Woo J, Leung J, Morley JE. Validating the SARC-F: a suitable community screening tool for sarcopenia? J Am Med Dir Assoc. 2014 Sep;15(9):630-4. doi: 10.1016/j.jamda.2014.04.021. Epub 2014 Jun 16.
PubMed 24947762
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Sarcopenia and Peripheral and Respiratory Muscle Strength in Geriatric Individuals
- ClinicalTrials.gov ID
- NCT06756399
- Acronym / sponsor ID
- 202412
- Conditions
- The Association Between Sarcopenia and the Strength of Peripheral and Respiratory Muscles in Elderly Individuals, Cardiovascular Diseases, Diabetes Mellitus, Hypertension
- Keywords
- Muscle strength, respiratory muscle strength, sarcopenia ., Cardiovascular diseases, Diabetes Mellitus, Hypertension
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Collaborators
- Çanakkale Onsekiz Mart University
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- 10 Feb 2025 (estimated)
- Study completion
- 24 Feb 2025 (estimated)
- First posted
- 3 Jan 2025 (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.
Population aging is a significant global trend, with projections indicating that by 2050, 1 in 6 individuals worldwide will be over 65 years old, compared to 1 in 11 in 2019. In Turkey, the elderly population is expected to rise to 11.0% by 2025 and reach 25.6% by 2080. Sarcopenia, characterized by the progressive loss of skeletal muscle mass (SMM) and function due to aging, affects approximately 29% of older adults in community healthcare settings. It is associated with various pathophysiological processes, leading to negative health outcomes like falls and frailty.
The European Working Group on Sarcopenia in Older People (EWGSOP) established diagnostic criteria for sarcopenia based on muscle mass, strength, and physical performance in 2010, later revised in 2018 (EWGSOP2), emphasizing low muscle strength as the primary diagnostic criterion. The SARC-F questionnaire is recommended for confirming sarcopenia, with a score of ≥ 4 indicating the condition.
The concept of respiratory sarcopenia, introduced in 2021, refers to the loss of respiratory muscle mass and strength alongside general body sarcopenia, though measuring respiratory muscle mass can be complex. Respiratory muscle strength can be assessed through mouth pressure measurement, but a consensus on the methodology is still lacking.
Overall, there is insufficient research on the relationship between peripheral and respiratory muscle weakness and sarcopenia in the elderly. This study aims to explore this relationship further.
Detailed description
Population aging is a global phenomenon characterized by a significant and rapid increase in the elderly population over recent years. According to World Population Prospects 2019 (United Nations, 2019), by 2050, 1 in 6 people in the world will be over the age of 65, up from 1 in 11 in 2019. It is estimated that the elderly population rate in our country will be 11.0% in 2025, 12.9% in 2030, 16.3% in 2040, 22.6% in 2060 and 25.6% in 2080.
Sarcopenia is a progressive and characterized loss of skeletal muscle mass (SMM) and function associated with aging. Several prospective studies have reported that skeletal muscle mass decreases by 6% per decade after middle age. In community healthcare settings, the prevalence of sarcopenia has been reported to reach up to 29% among older adults. Sarcopenia is thought to involve a variety of pathophysiological processes, including denervation, mitochondrial dysfunction, inflammatory and hormonal changes that can lead to adverse health outcomes such as falls, functional decline, frailty, weakness, and death due to a decrease in lean body mass. The European Working Group on Sarcopenia in Older People (EWGSOP) proposed three diagnostic criteria for sarcopenia based on muscle mass, muscle strength, and physical performance in 2010. The EWGSOP proposed for sarcopenia three diagnostic criteria; low muscle mass (LMM) is defined by a SMM index of less than 8.90 kg/m2, low muscle strength (LMS) by hand-grip strength below 30 kg in men and 20 kg in women, and low physical performance (LPP) by gait speeds of less than 0.8 m/s. In 2018, The European Working Group on Sarcopenia in Older People 2 (EWGSOP2) revised the diagnostic criteria and established that low muscle strength is the primary parameter for the diagnosis of sarcopenia and the most reliable measure of muscle function. In clinical practice, when a patient shows symptoms or signs of sarcopenia (i.e. falls, feeling weak, walking slowly and difficulty getting up from a chair, or weight loss or muscle wasting), the EWGSOP2 is recommended to use the SARC-F questionnaire, which consists of five items: Strength, Assistance in walking, Rising from a chair, Climbing stairs, and Falls to confirm the diagnosis. A score of the SARC-F questionnaire ≥ 4 is considered sarcopenia.
The concept of respiratory sarcopenia was first proposed in 2021 and is defined as "General body sarcopenia and low respiratory muscle mass followed by low respiratory muscle strength and/or low respiratory function." Diagnosis of respiratory sarcopenia is made by assessing respiratory muscle mass and strength. However, measuring respiratory muscle mass can often be complex, requiring advanced diagnostic equipment or techniques such as ultrasound echography and computed tomography. Assessing respiratory muscle strength is easier because it can be measured by mouth pressure measurement; however, there is no consensus yet on the exact methodology.
Studies showing the relationship between peripheral muscle and respiratory muscle weakness and sarcopenia in the elderly population are insufficient. In our study, we aim to examine the relationship between sarcopenia and peripheral and respiratory muscle strength.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly Individuals | – | Other: Questionnare, hand grip and respiratory muscle strengthThe study group was composed of volunteers aged 65-80 years. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- The Çanakkale Municipality Golden Years Life Center.
Key inclusion criteria (4 listed)
- 65 years to 80 years (Older ),
- Standardised Mini Mental Test score ≥ 20,
- Volunteering to participate in the study study
- Registered at the Çanakkale Municipality Golden Years Life Center.
Key exclusion criteria (4 listed)
- With with a history of respiratory disease or receiving treatment for respiratory disease
- With serious orthopedic diseases that may affect the measurements
- Diagnosed with dementia
- Smokers.
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 |
|---|---|---|
| Questionnare, hand grip and respiratory muscle strengthUpper extremity strength will be assessed using the Jamar hand dynamometer to measure hand grip strength. For lower extremity muscle strength, participants will undergo the five-repetition sit-to-stand test. Respiratory muscle strength, both inspiratory and expiratory, will be measured through mouth pressure assessments. Additionally, participants will complete a questionnaire addressing components related to sarcopenia diagnosis, including questions on strength, assistance with walking, rising from a chair, climbing stairs, and incidence of falls. | Other | Elderly Individuals |
Primary outcome
The sociodemographic data form
Time frame: baseline
Socio-demographic data of individuals (name-surname, age, gender, height, weight, smoking, occupation, education) will be collected with the demographic data collection form created by the researchers. In the clinical information section, other diseases and medications used will berecorded.
Hand grip strength
Time frame: baseline
Upper extremity strength will be measured by hand grip strenght with a Jamar hand dynamometer. Participants will be seated with the dynamometer in their dominant hand, elbows flexed at 90° and next to the body, and three consecutive measurements will be taken with a 1-minute interval between measurements. The highest value will be recorded.
The five-repetition sit-to-stand test
Time frame: baseline
Lower extremity muscle strength will be evaluated. Participants will test to cross their arms on their chest and sit down and stand up on a chair once for trial purposes. After the trial performance, they will be asked to sit down and stand up on the chair as quickly as possible without stopping, and the time will be recorded after the fifth repetition
Measurements of respiratory muscle strength
Time frame: baseline
Inspiratory and expiratory respiratory muscle strength will be evaluated by the mouth pressure measurement.
SARC-F questionnaire
Time frame: baseline
Participants will be asked the questionnaire about strength, assistance in walking, rising from a chair, climbing stairs, and falls components. Each component will be scored between 0-2. The total scores will be recorded that ranged from 0 to 10.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Background: PubMed 30272090Bahat G, Yilmaz O, Kilic C, Oren MM, Karan MA. Performance of SARC-F in Regard to Sarcopenia Definitions, Muscle Mass and Functional Measures. J Nutr Health Aging. 2018;22(8):898-903. doi: 10.1007/s12603-018-1067-8.
- Background: PubMed 21853769Bohannon RW. Five-repetition sit-to-stand test: usefulness for older patients in a home-care setting. Percept Mot Skills. 2011 Jun;112(3):803-6. doi: 10.2466/15.26.PMS.112.3.803-806.
- Background: PubMed 35535373Cho MR, Lee S, Song SK. A Review of Sarcopenia Pathophysiology, Diagnosis, Treatment and Future Direction. J Korean Med Sci. 2022 May 9;37(18):e146. doi: 10.3346/jkms.2022.37.e146.
- Background: PubMed 30956204Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun.
- Background: PubMed 23810110Malmstrom TK, Morley JE. SARC-F: a simple questionnaire to rapidly diagnose sarcopenia. J Am Med Dir Assoc. 2013 Aug;14(8):531-2. doi: 10.1016/j.jamda.2013.05.018. Epub 2013 Jun 25. No abstract available.
- 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 36554450Sawaya Y, Hirose T, Ishizaka M, Shiba T, Sato R, Kubo A, Urano T. Patterns of Changes in Respiratory Muscle Strength over 1 Year in Non-Sarcopenia, Sarcopenia, and Severe Sarcopenia. Int J Environ Res Public Health. 2022 Dec 9;19(24):16571. doi: 10.3390/ijerph192416571.
- Background: PubMed 24947762Woo J, Leung J, Morley JE. Validating the SARC-F: a suitable community screening tool for sarcopenia? J Am Med Dir Assoc. 2014 Sep;15(9):630-4. doi: 10.1016/j.jamda.2014.04.021. Epub 2014 Jun 16.
- Individual participant dataSharing planned: Undecided
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.
Buket Akıncı, Ass.Prof principal investigator
Biruni University
Questions about this trial
What is this clinical trial studying?
An observational study of The Association Between Sarcopenia and the Strength of Peripheral and Respiratory Muscles in Elderly Individuals and Cardiovascular Diseases, run by Biruni University.
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 4 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: opening soon, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Buket Akıncı, Ass.Prof (444 8 276, bakinci@biruni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sociodemographic data form (time frame: baseline). The study lists 5 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 NCT06756399, which also lists 8 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 3 Jan 2025.