Acıbadem University
Istanbul, Turkey (Türkiye)
NCT Number: NCT07753421
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.
Interested in participating?
Request Info60 year and older
All sexes
Observational
Istanbul, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Single assessment during the study visit (Day 1)
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)
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)
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)
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)
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)
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)
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)
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)
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.
Acibadem University
Other
The Relationship Between Comorbidity Burden, Cognitive Function, Gait Speed, and Respiratory Muscle Strength in Community-Dwelling Older Adults: A Cross-Sectional Observational Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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