ClinicalTrials.gg
Enrolling by invitationNCT07753421Updated Nov 4, 2026

Comorbidity, Cognition, Gait Speed, and Respiratory Muscle Strength in Older Adults

An observational study in Geriatrics, Older Adults (60 - 85 Years Old) and Aging, sponsored by Acibadem University. Enrolling by invitation at 1 site in Turkey (Türkiye). Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Acibadem University · Observational

Updated Nov 4, 2026Start date movedPrimary completion moved+1 moreGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
66
Ages
60 Years and older
Sex
All
01

Study summary

This cross-sectional observational study aims to examine the associations of comorbidity burden and cognitive function with gait speed and respiratory muscle strength in community-dwelling adults aged 60 years and older. The relationships of physical activity level and functional mobility with these outcomes will also be investigated.

Participants will complete interview-based questionnaires, cognitive assessments, and non-invasive measurements of gait speed, functional mobility, handgrip strength, and respiratory muscle strength during a single study visit. The Strength, Assistance with walking, Rise from a chair, Climb stairs, and Falls (SARC-F) questionnaire will also be administered to provide descriptive information about possible sarcopenia risk; however, no diagnosis or classification of sarcopenia will be performed. No treatment or experimental intervention will be administered.

Read the detailed description

Aging is accompanied by changes in several physiological systems that may affect mobility, muscle performance, respiratory function, and functional independence. A greater burden of chronic disease may be associated with reduced physical capacity, while changes in cognitive functions may influence motor control and walking performance. Respiratory muscle weakness may also be associated with limitations in mobility and overall physical performance. However, the combined associations of comorbidity burden and cognitive function with gait speed and respiratory muscle strength have not been fully characterized in community-dwelling older adults.

The primary objective of this cross-sectional observational study is to examine the associations of comorbidity burden and cognitive function with gait speed and respiratory muscle strength in adults aged 60 years and older. The study will also evaluate the relationships of physical activity level and functional mobility with these outcomes.

Following written informed consent, participants will undergo a standardized assessment during a single study visit. Demographic and clinical information, including age, sex, education level, body mass index, chronic diseases, and medication use, will be recorded. Comorbidity burden will be evaluated using the Charlson Comorbidity Index. Cognitive function will be assessed using the Mini-Mental State Examination and the Montreal Cognitive Assessment(MoCA). Physical activity level will be evaluated using the Physical Activity Scale for the Elderly.

The SARC-F questionnaire will be administered as part of the descriptive assessment to provide general information about possible sarcopenia risk. SARC-F results will not be used to diagnose sarcopenia or to classify participants according to sarcopenia status.

Physical assessments will include the 4-meter gait speed test, the Timed Up and Go test, and handgrip strength measurement. Respiratory muscle strength will be assessed by measuring maximal inspiratory pressure and maximal expiratory pressure using a portable digital respiratory pressure measurement device. Appropriate rest periods will be provided between repeated physical and respiratory measurements.

Associations between cognitive function, comorbidity burden, physical activity level, gait speed, mobility, handgrip strength, and respiratory muscle strength will be examined using correlation analyses and multiple linear regression models. As this is an observational study, no therapeutic intervention will be administered and participants' routine health care will not be modified.

This is a single-group, analytical cross-sectional observational study in which all measurements are obtained during a single study visit, without longitudinal follow-up or case-control grouping.

02

Conditions studied

  • Geriatrics
  • Older Adults (60 - 85 Years Old)
  • Aging

Keywords

  • older adults
  • geriatrics
  • respiratory muscle strength
  • MIP
  • gait speed
  • cognition
03

In context

Lead sponsor

Acibadem University is the lead sponsor of 220 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population will consist of community-dwelling adults aged 60 years and older who are able to communicate and complete the study assessments. Participants will be recruited from the community, if the required sample size cannot be reached, from older adult care centers after obtaining the necessary institutional permissions. All eligible participants will undergo the same questionnaires, cognitive assessments, and non-invasive physical and respiratory measurements during a single study visit.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Aged 60 years or older
  • Living in the community
  • Able to communicate sufficiently to participate in the study assessments
  • Willing and able to provide written

Exclusion criteria

Exclusion Criteria:

  • Severe cognitive impairment that prevents completion of the study assessments
  • Presence of an acute infection at the time of assessment
  • Severe cardiac failure
  • Severe respiratory failure
  • End-stage disease
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
66 participants (estimated)
Patient registry
No

Groups and cohorts

  • Older Adults

    Community-dwelling adults aged 60 years and older who will undergo assessments of comorbidity burden, cognitive function, physical activity level, gait speed, functional mobility, handgrip strength, and respiratory muscle strength during a single study visit. No intervention or treatment will be administered.

06

What researchers measure

Primary outcomes

  1. Maximal inspiratory pressure

    Maximal inspiratory pressure(MIP) will be measured in the seated position using a portable digital respiratory pressure measurement device. A nose clip will be used to prevent air leakage. At least three and no more than five maneuvers will be performed, with at least one minute of rest between maneuvers. The highest value sustained for at least one second will be recorded in centimeters of water pressure (cmH2O).

    Time frame: Single assessment during the study visit (Day 1)

  2. Gait speed

    Gait Speed Assessed by the 4-Meter Walk Test: Gait speed will be assessed over a marked, unobstructed 4-meter walking course. Participants will be instructed to walk at their usual daily walking speed. The test will be performed three times, with rest provided between trials when needed. The best performance will be recorded as gait speed in meters per second (m/s). Higher values indicate faster gait speed.

    Time frame: Single assessment during the study visit (Day 1)

Secondary outcomes

  1. Maximal Expiratory Pressure

    Maximal expiratory pressure(MEP) will be measured in the seated position using a portable digital respiratory pressure measurement device. A nose clip will be used to prevent air leakage. At least three and no more than five maneuvers will be performed, with at least one minute of rest between maneuvers. The highest value sustained for at least one second will be recorded in centimeters of water pressure (cmH2O).

    Time frame: Single assessment during the study visit (Day 1)

  2. Functional Mobility Assessed by the Timed Up and Go Test

    Functional mobility will be assessed using the Timed Up and Go Test. Participants will be instructed to stand up from a chair, walk three meters at a safe and usual speed, turn, walk back to the chair, and sit down. The test will be performed three times, and the best completion time will be recorded in seconds. A shorter completion time indicates better functional mobility.

    Time frame: Single assessment during the study visit (Day 1)

  3. Handgrip Strength

    Handgrip strength will be measured using a Jamar hand dynamometer. Participants will be seated upright with the shoulder adducted, the elbow flexed to 90 degrees, and the forearm in a neutral position. Three measurements will be performed with one-minute rest intervals, and the highest value will be recorded in kilograms (kg).

    Time frame: Single assessment during the study visit (Day 1)

Other outcomes

  1. Comorbidity Burden Assessed by the Charlson Comorbidity Index

    Comorbidity burden will be assessed using the Charlson Comorbidity Index during a face-to-face interview. Questions will be administered to the participant, responses will be recorded by the researcher, and the total index score will be used in the analyses. Higher scores indicate a greater comorbidity burden.

    Time frame: Single assessment during the study visit (Day 1)

  2. Cognitive Function with Montreal Cognitive Assessment

    Cognitive function will be assessed using The Montreal Cognitive Assessment (MoCA) in a quiet environment under the supervision of a researcher. The assessment will include standardized verbal questions and paper-and-pencil tasks. The total score will be recorded, with higher scores indicating better cognitive performance. Montreal Cognitive Assessment's total score ranges from 0 to 30, with higher scores indicating better cognitive function.The total score will be analyzed as a continuous variable and will not be used alone to establish a clinical diagnosis.

    Time frame: Single assessment during the study visit (Day 1)

  3. Cognitive Function with Mini-Mental State Examination

    Cognitive function will be assessed using the Mini-Mental State Examination in a quiet environment under the supervision of a researcher. The assessment will include standardized verbal questions and paper-and-pencil tasks. The total score will be recorded, with higher scores indicating better cognitive performance. Mini-Mental State Examination's total score ranges from 0 to 30, with higher scores indicating better global cognitive function; total score will be analyzed as a continuous variable and will not be used alone to establish a clinical diagnosis.

    Time frame: Single assessment during the study visit (Day 1)

  4. Physical Activity Level Assessed by the Physical Activity Scale for the Elderly

    Physical activity level will be assessed using the Physical Activity Scale for the Elderly during a face-to-face interview. Questions will be administered to the participant, responses will be recorded by the researcher, and the total score will be used in the analyses. Higher scores indicate a higher level of physical activity.

    Time frame: Single assessment during the study visit (Day 1)

07

Study locations

1 site
08

References and documents

Publications

  • Simoes LA, Dias JM, Marinho KC, Pinto CL, Britto RR. [Relationship between functional capacity assessed by walking test and respiratory and lower limb muscle function in community-dwelling elders]. Rev Bras Fisioter. 2010 Jan-Feb;14(1):24-30. Portuguese. PubMed 20414558 ↗
  • Montero-Odasso M, Verghese J, Beauchet O, Hausdorff JM. Gait and cognition: a complementary approach to understanding brain function and the risk of falling. J Am Geriatr Soc. 2012 Nov;60(11):2127-36. doi: 10.1111/j.1532-5415.2012.04209.x. Epub 2012 Oct 30. PubMed 23110433 ↗
  • Enright PL, Kronmal RA, Manolio TA, Schenker MB, Hyatt RE. Respiratory muscle strength in the elderly. Correlates and reference values. Cardiovascular Health Study Research Group. Am J Respir Crit Care Med. 1994 Feb;149(2 Pt 1):430-8. doi: 10.1164/ajrccm.149.2.8306041. PubMed 8306041 ↗
  • Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8. PubMed 3558716 ↗
  • Holtzer R, Verghese J, Xue X, Lipton RB. Cognitive processes related to gait velocity: results from the Einstein Aging Study. Neuropsychology. 2006 Mar;20(2):215-23. doi: 10.1037/0894-4105.20.2.215. PubMed 16594782 ↗
  • American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available. PubMed 12186831 ↗

Individual participant data

Plan to share: No — Individual participant data will not be shared because data sharing with external researchers is not included in the current study protocol or informed consent process. Participant confidentiality and privacy will be protected. Study findings may be disseminated in aggregate form through scientific publications and presentations, without information that could identify individual participants.

09

Updates

1 registry update since Sep 25, 2026
Start date
Aug 10, 2026→Aug 15, 2026 (actual)
Nov 4, 2026
Primary completion
Jul 1, 2027→Apr 1, 2027
Nov 4, 2026
Study completion
Sep 1, 2027→Jul 1, 2027
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    Start date Aug 10, 2026→Aug 15, 2026 (now actual)
    Primary completion Jul 1, 2027→Apr 1, 2027
    Study completion Sep 1, 2027→Jul 1, 2027

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07753421
Collaborators
Biruni University
Responsible party
Ozge Hakli (Research Assistant, Acibadem University) — Principal investigator
First posted
Aug 7, 2026
Start date
Aug 15, 2026
Primary completion
Apr 1, 2027 (estimated)
Completion
Jul 1, 2027 (estimated)
Last update
Nov 4, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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