Menu
Enrolling by invitation NCT07753421

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Geriatrics, Older Adults (60 - 85 Years Old), Aging. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The Relationship Between Comorbidity Burden, Cognitive Function, Gait Speed, and Respiratory Muscle Strength in Community-Dwelling Older Adults: A Cross-Sectional Observational Study

Overview

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.

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.

Primary outcome measures

  • Maximal inspiratory pressure [Time frame: Single assessment during the study visit (Day 1)]
  • Gait speed [Time frame: Single assessment during the study visit (Day 1)]
Secondary outcome measures (3)
  • Maximal Expiratory Pressure [Time frame: Single assessment during the study visit (Day 1)]
  • Functional Mobility Assessed by the Timed Up and Go Test [Time frame: Single assessment during the study visit (Day 1)]
  • Handgrip Strength [Time frame: Single assessment during the study visit (Day 1)]

Eligibility criteria

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 informed consent

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Turkey (Türkiye) · 1 center
  • Acıbadem University — Istanbul

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 12186831

Identifiers

NCT: NCT07753421 · 2026-13/149

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗