NCT07753421

Brief 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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
13mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Aug 2026Sep 2027

First Submitted

Initial submission to the registry

August 3, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 7, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

August 10, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

August 7, 2026

Status Verified

August 1, 2026

Enrollment Period

11 months

First QC Date

August 3, 2026

Last Update Submit

August 6, 2026

Conditions

Keywords

older adultsgeriatricsrespiratory muscle strengthMIPgait speedcognition

Outcome Measures

Primary Outcomes (2)

  • 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).

    Single assessment during the study visit (Day 1)

  • 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.

    Single assessment during the study visit (Day 1)

Secondary Outcomes (3)

  • Maximal Expiratory Pressure

    Single assessment during the study visit (Day 1)

  • Functional Mobility Assessed by the Timed Up and Go Test

    Single assessment during the study visit (Day 1)

  • Handgrip Strength

    Single assessment during the study visit (Day 1)

Other Outcomes (4)

  • Comorbidity Burden Assessed by the Charlson Comorbidity Index

    Single assessment during the study visit (Day 1)

  • Cognitive Function with Montreal Cognitive Assessment

    Single assessment during the study visit (Day 1)

  • Cognitive Function with Mini-Mental State Examination

    Single assessment during the study visit (Day 1)

  • +1 more other outcomes

Study Arms (1)

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.

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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 informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acıbadem University

Istanbul, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 20414558BACKGROUND
  • 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.

    PMID: 23110433BACKGROUND
  • 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.

    PMID: 8306041BACKGROUND
  • 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.

    PMID: 3558716BACKGROUND
  • 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.

    PMID: 16594782BACKGROUND
  • 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.

    PMID: 12186831BACKGROUND

Study Design

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

Study Record Dates

First Submitted

August 3, 2026

First Posted

August 7, 2026

Study Start

August 10, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

August 7, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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.

Locations