NCT06994598

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2025

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 29, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

May 29, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

April 25, 2025

Last Update Submit

May 20, 2025

Conditions

Outcome Measures

Primary Outcomes (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.

    Baseline

Secondary Outcomes (8)

  • Demographic and Clinical Information

    Baseline

  • Body composition

    Baseline

  • Grip Force Measurement

    Baseline

  • 5 Repetition Sit and Stand Test

    Baseline

  • 4 Meter Walking Speed Test (4MWT)

    Baseline

  • +3 more secondary outcomes

Study Arms (1)

Geriatric Individuals

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Volunteers aged 65 and over.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Central Study Contacts

Muhammed İhsan KODAK, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

April 25, 2025

First Posted

May 29, 2025

Study Start

May 1, 2025

Primary Completion

August 1, 2025

Study Completion

September 1, 2025

Last Updated

May 29, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share