Cognitive ChangeNCT06400134
Coginitve and Physical Functions in Geriatric İndividuals
An observational study of Cognitive Change and Physical Performance, run by Ankara Yildirim Beyazıt University at 2 sites in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the relationship between cognitive functions with physical performance, grip strength, walking speed, mobility, and frailty in geriatric individuals. Decline in cognitive function and decline in physical performance are generally associated with advanced age. Read more about this study
- Who is it for?
- Ages 65 to 82 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change, Physical Performance, Frailty
- What is being tested?
- Cognitive Function, Physical Performance and Grip Strength
- How many people
- 50 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Jun 2022to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 to 82 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Geriatric individuals
Who may be able to join
- Volunteer healthy geriatric individuals aged 65 years and over
- Able to walk independently
Who cannot join
- Without neurological and rheumatological diseases,
- Without acute musculoskeletal problems in the lower extremities
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ankara Yıldırım Beyazıt University, Faculty of Health Sciences,Department of Physiotherapy and Rehabilitation
Ankara, Esenboğa, 06970
Ankara Yıldırım Beyazıt University
Ankara
About this study
Official title: Investigation of the Relationship of Cognitive Functions With Physical Performance, Grip Strength, Walking Speed, Mobility, and Frailty in Geriatric Individuals
The aim of this study is to investigate the relationship between cognitive functions with physical performance, grip strength, walking speed, mobility, and frailty in geriatric individuals.
Decline in cognitive function and decline in physical performance are generally associated with advanced age. Cognitive dysfunction is a natural consequence of ageing and is an important factor in maintaining quality of life and independence. Investigating the relationship between cognition, physical performance, mobility, and frailty has become a challenging issue in recent years. However, there is a need to further clarify the direction of this cognitive-motor link.
- Conditions
- Cognitive Change, Physical Performance, Frailty, Mobility
- Being tested
- Cognitive Function, Physical Performance, Grip Strength, Walking speed, Mobility
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive FunctionOther
The Standardized Mini Mental Test (SMMT) was used to evaluate the cognitive status of the geriatric individuals'. In the test, which has a total score of 30, those with a score of 24 or less are recommended to be evaluated for dementia.
Physical PerformanceOther
The Brief Physical Performance Battery (BPPB) was used to assess the physical performance of geriatric individuals. All three physical performance measures (balance, walking speed, getting up from the chair) were scored between 0-4 according to the duration of the activity, these scores were summed and the total score was determined between 0 (poor) and 12 (very good).
Grip StrengthOther
Muscle strength was assessed with a hand grip dynamometer. In the geriatric individuals, less than 30 kg for men and less than 20 kg for women was considered as low hand grip strength.
Walking speedOther
Walking speed was assessed with the 6-metre walk test. Speed was calculated by dividing each known distance by the time it took for each individual, on each trial, to walk from the start to the end points marked on the floor and then converting to m/s.
MobilityOther
The Time up Go test (TUG) was used for mobility. The risk of falling increases with increasing duration.
FrailityOther
Frailty assessment was performed using the FRAIL scale.The scale was scored by giving 0 or 1 point according to the answer given. The higher the score, the greater the fraility.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric individuals | Volunteer healthy geriatric individuals aged 65 years and over Receives: Other: Cognitive Function; Other: Physical Performance; Other: Grip Strength; Other: Walking speed; Other: Mobility; Other: Fraility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition function
The Standardised Mini Mental Test, which evaluates cognitive functions, consists of a total of 30 points. Those who score 24 and below are evaluated for dementia.
Measured: 4 month
Secondary outcomes (5)
Physical Performance
The Brief Physical Performance Battery (BPPB) was used to assess the physical performance.All three physical performance measures (balance, walking speed, getting up from the chair) were scored between 0-4 according to the duration of the activity, these scores were summed and the total score was determined between 0 (poor) and 12 (very good).
Measured: 4 month
Grip Strength
Muscle strength was assessed with a hand grip dynamometer. In the geriatric individuals, less than 30 kg for men and less than 20 kg for women was considered as low hand grip strength
Measured: 4 month
Walking speed
Walking speed was assessed with the 6-metre walk test. Speed was calculated by dividing each known distance by the time it took for each individual, on each trial, to walk from the start to the end points marked on the floor and then converting to m/s
Measured: 1 month
Mobility
The Time up Go test (TUG) was used for mobility. Completion in more than 12 seconds indicates a high fall risk in geriatric individuals
Measured: 4 month
Frailty
Frailty assessment was performed using the FRAIL scale. The scale was scored by giving 0 or 1 point according to the answer given. As a result, a total score of 0 was defined as normal, between 1-2 points as pre-frailty, and above 2 points as frail
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start1 Jun 2022
- Primary completion15 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies 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
- Other
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Yildirim Beyazıt University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400134
- Sponsor's protocol ID
- 2022-08
- Status last verified
- May 2024
- First submitted
- 30 Apr 2024
- Last updated
- 6 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship of Cognitive Functions With Physical Performance, Grip Strength, Walking Speed, Mobility, and Frailty in Geriatric Individuals
- ClinicalTrials.gov ID
- NCT06400134
- Acronym / sponsor ID
- 2022-08
- Conditions
- Cognitive Change, Physical Performance, Frailty, Mobility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ankara Yildirim Beyazıt UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 6 May 2024 (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.
The aim of this study is to investigate the relationship between cognitive functions with physical performance, grip strength, walking speed, mobility, and frailty in geriatric individuals.
Decline in cognitive function and decline in physical performance are generally associated with advanced age. Cognitive dysfunction is a natural consequence of ageing and is an important factor in maintaining quality of life and independence. Investigating the relationship between cognition, physical performance, mobility, and frailty has become a challenging issue in recent years. However, there is a need to further clarify the direction of this cognitive-motor link.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric individuals | – | Other: Cognitive Function, Other: Physical Performance, Other: Grip Strength, Other: Walking speed, Other: Mobility, Other: FrailityVolunteer healthy geriatric individuals aged 65 years and over |
Who may qualify
- Ages
- 65 to 82 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Geriatric individuals
Key inclusion criteria (2 listed)
- Volunteer healthy geriatric individuals aged 65 years and over
- Able to walk independently
Key exclusion criteria (2 listed)
- Without neurological and rheumatological diseases,
- Without acute musculoskeletal problems in the lower extremities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive FunctionThe Standardized Mini Mental Test (SMMT) was used to evaluate the cognitive status of the geriatric individuals'. In the test, which has a total score of 30, those with a score of 24 or less are recommended to be evaluated for dementia. | Other | Geriatric individuals |
| Physical PerformanceThe Brief Physical Performance Battery (BPPB) was used to assess the physical performance of geriatric individuals. All three physical performance measures (balance, walking speed, getting up from the chair) were scored between 0-4 according to the duration of the activity, these scores were summed and the total score was determined between 0 (poor) and 12 (very good). | Other | Geriatric individuals |
| Grip StrengthMuscle strength was assessed with a hand grip dynamometer. In the geriatric individuals, less than 30 kg for men and less than 20 kg for women was considered as low hand grip strength. | Other | Geriatric individuals |
| Walking speedWalking speed was assessed with the 6-metre walk test. Speed was calculated by dividing each known distance by the time it took for each individual, on each trial, to walk from the start to the end points marked on the floor and then converting to m/s. | Other | Geriatric individuals |
| MobilityThe Time up Go test (TUG) was used for mobility. The risk of falling increases with increasing duration. | Other | Geriatric individuals |
| FrailityFrailty assessment was performed using the FRAIL scale.The scale was scored by giving 0 or 1 point according to the answer given. The higher the score, the greater the fraility. | Other | Geriatric individuals |
Primary outcome
Cognition function
Time frame: 4 month
The Standardised Mini Mental Test, which evaluates cognitive functions, consists of a total of 30 points. Those who score 24 and below are evaluated for dementia.
5 secondary outcomes
Physical Performance
Time frame: 4 month
Grip Strength
Time frame: 4 month
Walking speed
Time frame: 1 month
Mobility
Time frame: 4 month
Frailty
Time frame: 4 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Change and Physical Performance, run by Ankara Yildirim Beyazıt University at 2 sites 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cognition function (time frame: 4 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2024.