GeriatricsNCT07753421
Comorbidity, Cognition, Gait Speed, and Respiratory Muscle Strength in Older Adults
An observational study of Geriatrics and Older Adults (60 - 85 Years Old), run by Acibadem University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Geriatrics, Older Adults (60 - 85 Years Old), Aging
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2026to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Geriatrics, Older Adults (60 - 85 Years Old), Aging
- Keywords
- older adults, geriatrics, respiratory muscle strength, MIP, gait speed, cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Single assessment during the study visit (Day 1)
Secondary outcomes (3)
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).
Measured: Single assessment during the study visit (Day 1)
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.
Measured: Single assessment during the study visit (Day 1)
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).
Measured: Single assessment during the study visit (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start10 Aug 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for GeriatricsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Collaborators
- Biruni University
- Responsible party
- Principal investigator, Ozge Hakli, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07753421
- Sponsor's protocol ID
- 2026-13/149
- Status last verified
- Aug 2026
- First submitted
- 3 Aug 2026
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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 20414558Montero-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 23110433Enright 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 8306041Charlson 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 3558716Holtzer 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 16594782American 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07753421
- Acronym / sponsor ID
- 2026-13/149
- Conditions
- Geriatrics, Older Adults (60 - 85 Years Old), Aging
- Keywords
- older adults, geriatrics, respiratory muscle strength, MIP, gait speed, cognition
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Collaborators
- Biruni University
- Study start
- 10 Aug 2026 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 7 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Maximal inspiratory pressure
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).
Gait speed
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.
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Background: PubMed 20414558Simoes 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.
- Background: PubMed 23110433Montero-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.
- Background: PubMed 8306041Enright 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.
- Background: PubMed 3558716Charlson 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.
- Background: PubMed 16594782Holtzer 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.
- Background: PubMed 12186831American 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Geriatrics and Older Adults (60 - 85 Years Old), run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal inspiratory pressure (time frame: Single assessment during the study visit (Day 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07753421, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.