AzTrials
AzTrials

GeriatricNCT06994598

Investigation of Respiratory Muscle Sarcopenia in Geriatric Individuals

An observational study of Geriatric and Sarcopenia, run by Kirsehir Ahi Evran Universitesi.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The increase in the elderly population worldwide necessitates further research on age-related physiological changes and health problems related to these changes in geriatric individuals. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Geriatric, Sarcopenia, Diaphragm
How many people
85 participants
Where
No sites listed yet
Study dates
May 2025to Sep 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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Study population: Volunteers aged 65 and over.

Who may be able to join

  • Being 65 years of age or older.
  • Being clinically stable
  • Being able to adapt to tests (visual, cognitive, cooperative)

Who cannot join

  • Those with neurological and/or musculoskeletal problems that may affect the study
  • Presence of severe joint contracture or painful ulcers that may affect muscle strength measurement and walking
  • Presence of serious infection or sepsis
  • Having a known additional rheumatologic disease diagnosis
  • Any stage of cancer

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Muhammed İhsan KODAK, PhD contact

05532333661

mihsankodak@ahievran.edu.tr

About this study

The increase in the elderly population worldwide necessitates further research on age-related physiological changes and health problems related to these changes in geriatric individuals. One of these problems, sarcopenia, is a syndrome characterized by a decrease in muscle mass, muscle strength, and physical performance due to aging (Cruz-Jentoft et al., 2019). Sarcopenia affects not only the extremity muscles but also the respiratory muscles, significantly reducing the individual's functional capacity and quality of life (Shafiee et al., 2017). Sarcopenia is a progressive and widespread loss of skeletal muscles, characterized by a decrease in muscle strength, muscle mass, and physical performance. Although it is usually seen in older individuals, it can also occur in people with certain diseases or who lead a sedentary lifestyle. The European Working Group on Sarcopenia in Older People (EWGSOP) has developed a guideline for the diagnosis of sarcopenia and determination of its severity (Cruz-Jentoft et al., 2019). In line with this guideline, the EWGSOP considers sarcopenia in three basic stages: pre-sarcopenia, sarcopenia, and severe sarcopenia (Cruz-Jentoft et al., 2010). Pre-sarcopenia is the stage in which muscle mass is low but muscle strength or physical performance is not yet affected. Sarcopenia is the stage in which low muscle mass is accompanied by decreased muscle strength or low physical performance. Severe sarcopenia is defined as the most advanced stage in which all these criteria are met (Cruz-Jentoft et al., 2010). Respiratory muscle sarcopenia is defined as muscle fiber atrophy and weakness in the respiratory muscles. The Japanese Respiratory Sarcopenia Study Group defines this condition as whole-body sarcopenia with low respiratory muscle mass, decreased respiratory muscle strength, and/or respiratory dysfunction (Nagano et al., 2021). Kera et al. (2019) evaluated respiratory muscle sarcopenia according to the peak expiratory flow rate value. However, whole-body sarcopenia and respiratory muscle strength are considered important parameters in the definition and diagnosis of respiratory muscle sarcopenia. It is reported that the rate of respiratory muscle sarcopenia is higher in the presence of sarcopenia (Nagano et al., 2021). Sarcopenic respiratory failure is diagnosed in the presence of sarcopenia accompanied by functional disability, while individuals without functional disability but at risk for respiratory muscle sarcopenia are considered "at risk of sarcopenic respiratory failure" (Nagano et al., 2021). Sarcopenia is thought to be associated with insulin resistance and oxidative stress, leading to decreased muscle strength and muscle mass, as well as muscle atrophy (Ding et al., 2019). Respiratory muscles may also be affected in a similar way. Thus, weakening of respiratory muscles may lead to decreased respiratory function and decreased quality of life. In the current literature, studies examining the effects of aging on respiratory muscles are limited. Therefore, determining the potential effects of aging on respiratory muscles and evaluating respiratory muscle sarcopenia in this context may provide an important contribution to the development of new approaches and the literature.

Medical subject headings
Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06994598
Study groupRoleWhat they receive
Geriatric IndividualsNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Respiratory Muscle Sarcopenia Assessment

    The diagnosis of respiratory muscle sarcopenia will also be made by combining the results of secondary measurements.

    Participants included in the study:

    Hand grip strength \<27 kg for men and \<16 kg for women, Bioelectrical Impedance Analysis (Skeletal muscle mass (SMM)\<20 kg for men and \< 15 kg for women) the participant is diagnosed with sarcopenia. They will also be diagnosed with a frailty phenotype based on the results of the Timed Stand and Walk Test, the 4 meter walk test and the 5 Repetition Sit and Stand Test.

    Participants diagnosed with sarcopenia will be diagnosed with respiratory muscle sarcopenia if respiratory muscle weakness is also detected.

    Measured: Baseline

Secondary outcomes (8)
  1. Demographic and Clinical Information

    Information on age, height (meter), body weight (kg), gender, educational status, occupation, medication use, exercise habits and disease will be evaluated. These data will be recorded on pre-prepared forms.

    Measured: Baseline

  2. Body composition

    Body mass and body composition will be measured using bioelectrical impedance method. The variables to be assessed are body mass index (BMI = body mass (kg)/height2 (m)2 ), fat mass (pFM) expressed as a percentage of body mass, fat-free mass (FFM) expressed in kilograms, and appendicular skeletal muscle mass (ASMM) and skeletal muscle mass (SMM) expressed in kilograms. Data will be collected with a bioelectrical impedance device and recorded on pre-prepared forms. The measurement will be made with a Tanita brand device. All measurement results will be obtained from the measurement report given by the device.

    Measured: Baseline

  3. Grip Force Measurement

    The hand muscle grip strength of the individuals will be measured with a hand dynamometer. During the measurement, the position recommended by the American Association of Hand Therapists (ASHT); the participant will be in an upright sitting position and no arm support will be allowed on the sitting surface. The elbow and knee angle will be set to 90°. The wrist will be held without deviation. The measurement will be performed 3 times with an interval of 10 seconds and the highest value will be used in the study.

    Measured: Baseline

  4. 5 Repetition Sit and Stand Test

    An armless chair with a straight back support and a rigid seat at a height of 48 cm from the floor will be fixed to the wall. Participants will be asked to sit on the chair and come forward in the chair until their feet are flat on the floor. Participants will be asked to do a "stand and sit" movement once with their arms crossed across their chest. The test will be terminated for those who cannot complete the task or need assistance. Those who successfully complete the first task will be asked to perform five consecutive stand and sit as fast as possible. The timing is started with the command start and stopped at the end of the fifth posture. Our participants test scores will be recorded in seconds using a stopwatch.

    Measured: Baseline

  5. 4 Meter Walking Speed Test (4MWT)

    4MWT is a measure of walking speed, a vital sign of mobility and functionality. In older adults, walking speed is a clinical indicator of conditions such as frailty and sarcopenia. Participants were instructed to start walking at their normal speed 2 m behind the "start point" and continue until they passed the "end point". Using a stopwatch, the time taken for each participant to walk the 4 m distance between the "start" and "end" point will be measured. This will be used to calculate walking speed (distance/time).

    Measured: Baseline

  6. Timed Up and Go Test (TUG)

    This functional test measures the time it takes for an individual to stand up from a standard chair, walk 3 m at normal speed, turn around, walk back to the starting point and sit down. Using a stopwatch, participants test scores are recorded in seconds.

    Measured: Baseline

  7. Respiratory muscle strength

    Intraoral pressure will be measured with a measuring device. They are easily applicable and simple measurements. Maximal voluntary inspiratory and expiratory pressures (MIP and MEP) are the most commonly used noninvasive methods to measure respiratory muscle strength. It is based on Müller (maximal inspiration) and Valsalva (maximal expiration).

    Measured: Baseline

  8. 6 Minute Walk Test (6MWT):

    The 6-minute walk test is used as a simple measure of aerobic exercise and functional capacity. During this test, a 30-meter track with a hard surface is walked at a normal pace for six minutes. This track is marked every 3 meters and a cone is placed at the end of this 30-meter track and the same track is returned around it. During the test, participants must walk at a speed appropriate to their condition and are allowed to stop or slow down if they wish and continue walking as soon as possible. Initial oxygen saturation, heart rate and blood pressure are measured. In addition, the Borg scale rating is used for shortness of breath and fatigue.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 May 2025
  2. Study startMay 2025 (estimated)
  3. Primary completionAug 2025 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

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
85 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06994598
Sponsor's protocol ID
2025-AEU-FTR-MK-02
Status last verified
Apr 2025
First submitted
25 Apr 2025
Last updated
29 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Geriatric and Sarcopenia, run by Kirsehir Ahi Evran Universitesi.

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 3 inclusion and 5 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 29 May 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 Muhammed İhsan KODAK, PhD (05532333661, mihsankodak@ahievran.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Respiratory Muscle Sarcopenia Assessment (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 29 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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