Cognitive ChangeNCT05925582
Vestibular-Based Exercises vs. Calisthenic Exercises for Cognitive Functions
A study testing vestibular based exercise program and calisthenic based exercise program in people with Cognitive Change, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to determine the effects of vestibular-based exercises (VBE) and calisthenic-based exercises (CBE) on the cognitive functions of the older individuals. A total of 30 people (21 male, 9 female; range: 65 - 85) will participate in the study. Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Cognitive Change
- What is being tested?
- vestibular based exercise program and calisthenic based exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 15 Nov 2023
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Male and female individuals aged 65-85 years living in a nursing home.
- Individuals who are self-sufficient (independent) in daily life (including those who use a cane or canadian).
- Volunteer to participate in the study.
Who cannot join
- Having an orthopedic, neurological or psychiatric disorder that would prevent the evaluation and exercise program in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Faculty of Health Sciences in Biruni University
Istanbul, Zeytinburnu, 34010
About this study
Official title: Comparison of the Effects of Vestibular-based and Callisthenic-based Exercises on Cognitive Function and Dual Task in Ambulatory Older Adults Living in Nursing Homes: A Randomized Controlled Trial.
This study was planned to determine the effects of vestibular-based exercises (VBE) and calisthenic-based exercises (CBE) on the cognitive functions of the older individuals. A total of 30 people (21 male, 9 female; range: 65 - 85) will participate in the study. In this randomized controlled study, 30 participants will be divided into two groups: VBE Group (n: 15) and CBE Group (n: 15). Standardized Mini Mental State Test (SMMT) and 3 dual task (motor + cognitive: Dual Task 1, 2, 3) tests will be used to evaluate the cognitive functions of the participants.
Read the detailed description
All the evaluations will be done before and after the 8-week exercise program (three times a week). Each group participants will be divided into 3 groups (each group consists of 5 persons) and involved in an 8-week (3 days a week) exercise program (warm-up, VBE or CBE, cool-down).
- Conditions
- Cognitive Change
- Being tested
- vestibular based exercise program, calisthenic based exercise program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vestibular based exercise programOther
this group's participants will involve in vestibular based exercise program
calisthenic based exercise programOther
this group's participants will involve in calisthenic based exercise program
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | All the participants in Group 1 will receive a 8-week vestibular based exercises program 3 times in a week. Receives: Other: vestibular based exercise program |
| Group 2 | Active comparator | All the participants in Group 1 will receive a 8-week calistenic based exercises program 3 times in a week. Receives: Other: calisthenic based exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Standardized Mini Mental State Test (SMMT)
It was first developed by Folstein et al. (1975) to assess mental status. Then a standardized version was produced by Molloy and Standish (1997). The Turkish version was prepared by 3 psychiatrists (CG, TE, EE). This test, which is applied to evaluate the mental state, examines cognitive functions in five parts. These sections are; orientation, recording, attention and calculation, recall and language. The highest score is 30. Those who score 24 and below are evaluated within the framework of dementia.
Measured: 15 min.
Dual task 1 (Motor + Cognitive) Test
Dual task 1 (Motor + Cognitive) Test This test will be used to perform a cognitive task while walking a distance of 10 meters in the person. In an area of 10 meters, the walking speed of the person is examined with the help of a stopwatch. The participant is asked to walk within a 10 meter area. Time starts when the person's foot is on the starting line and ends when he crosses the finish line. The measurement is made and the result is recorded in meters/second (m/s). In order to evaluate their cognitive functions, the participant is asked to count from 1 to 20 during walking.
Measured: 10 min.
Dual task 2 (Motor + Cognitive) Test
The person sits down and numbers from 1 to 10 of different colors are placed on the floor. Before the test starts, 10 different commands are determined for the participant and when the test starts, these commands are said in order. The test score is determined according to the ability to execute the given commands.
Measured: 5 min.
Dual task 3 (Motor + Cognitive) Test
Part B of the Trail Making Test will be used. The Tracking Test was first created by psychologists working in the United States Army (Reitan 1955) and is a widely used neuropsychological test. This test requires visuospatial processing and motor skills. It consists of two parts, A and B. Part A evaluates the rate of activation based on visual scanning ability, and part B evaluates the ability to change setup and follow sequencing between sets of stimuli. Part B is more complex and takes longer to complete because it requires more visual-spatial processing than part A. Also, the difficulty level of Part B is higher than Part A because it requires more motor speed, agility and attention. That's why we chose part B of the test for this research. Participants first make a short sample of the test. Then comes the actual test.
Measured: 10 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Jun 2023
- Primary completion3 Aug 2023
- Study completion15 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two groups: Interventional (study) group and Control group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ugur Cavlak, Biruni University
- Investigators
- UGUR CAVLAK, Prof., Study director, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925582
- Sponsor's protocol ID
- 2022/7614
- Status last verified
- Dec 2024
- First submitted
- 22 Jun 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: AFTER COMPLETED THE STUDY.
Publications
Li L, Liu M, Zeng H, Pan L. Multi-component exercise training improves the physical and cognitive function of the elderly with mild cognitive impairment: a six-month randomized controlled trial. Ann Palliat Med. 2021 Aug;10(8):8919-8929. doi: 10.21037/apm-21-1809.
PubMed 34488379Langlois F, Vu TT, Chasse K, Dupuis G, Kergoat MJ, Bherer L. Benefits of physical exercise training on cognition and quality of life in frail older adults. J Gerontol B Psychol Sci Soc Sci. 2013 May;68(3):400-4. doi: 10.1093/geronb/gbs069. Epub 2012 Aug 28.
PubMed 22929394
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Vestibular-based and Callisthenic-based Exercises on Cognitive Function and Dual Task in Ambulatory Older Adults Living in Nursing Homes: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05925582
- Acronym / sponsor ID
- 2022/7614
- Conditions
- Cognitive Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 3 Aug 2023 (actual)
- Study completion
- 15 Nov 2023 (actual)
- First posted
- 29 Jun 2023 (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 study was planned to determine the effects of vestibular-based exercises (VBE) and calisthenic-based exercises (CBE) on the cognitive functions of the older individuals. A total of 30 people (21 male, 9 female; range: 65 - 85) will participate in the study. In this randomized controlled study, 30 participants will be divided into two groups: VBE Group (n: 15) and CBE Group (n: 15). Standardized Mini Mental State Test (SMMT) and 3 dual task (motor + cognitive: Dual Task 1, 2, 3) tests will be used to evaluate the cognitive functions of the participants.
Detailed description
All the evaluations will be done before and after the 8-week exercise program (three times a week). Each group participants will be divided into 3 groups (each group consists of 5 persons) and involved in an 8-week (3 days a week) exercise program (warm-up, VBE or CBE, cool-down).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two groups: Interventional (study) group and Control group
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: vestibular based exercise programAll the participants in Group 1 will receive a 8-week vestibular based exercises program 3 times in a week. |
| Group 2 | Active comparator | Other: calisthenic based exercise programAll the participants in Group 1 will receive a 8-week calistenic based exercises program 3 times in a week. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Male and female individuals aged 65-85 years living in a nursing home.
- Individuals who are self-sufficient (independent) in daily life (including those who use a cane or canadian).
- Volunteer to participate in the study.
Key exclusion criteria (1 listed)
- Having an orthopedic, neurological or psychiatric disorder that would prevent the evaluation and exercise program in the study.
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 |
|---|---|---|
| vestibular based exercise programthis group's participants will involve in vestibular based exercise program | Other | Group 1 |
| calisthenic based exercise programthis group's participants will involve in calisthenic based exercise program | Other | Group 2 |
Primary outcome
Standardized Mini Mental State Test (SMMT)
Time frame: 15 min.
It was first developed by Folstein et al. (1975) to assess mental status. Then a standardized version was produced by Molloy and Standish (1997). The Turkish version was prepared by 3 psychiatrists (CG, TE, EE). This test, which is applied to evaluate the mental state, examines cognitive functions in five parts. These sections are; orientation, recording, attention and calculation, recall and language. The highest score is 30. Those who score 24 and below are evaluated within the framework of dementia.
Dual task 1 (Motor + Cognitive) Test
Time frame: 10 min.
Dual task 1 (Motor + Cognitive) Test This test will be used to perform a cognitive task while walking a distance of 10 meters in the person. In an area of 10 meters, the walking speed of the person is examined with the help of a stopwatch. The participant is asked to walk within a 10 meter area. Time starts when the person's foot is on the starting line and ends when he crosses the finish line. The measurement is made and the result is recorded in meters/second (m/s). In order to evaluate their cognitive functions, the participant is asked to count from 1 to 20 during walking.
Dual task 2 (Motor + Cognitive) Test
Time frame: 5 min.
The person sits down and numbers from 1 to 10 of different colors are placed on the floor. Before the test starts, 10 different commands are determined for the participant and when the test starts, these commands are said in order. The test score is determined according to the ability to execute the given commands.
Dual task 3 (Motor + Cognitive) Test
Time frame: 10 min.
Part B of the Trail Making Test will be used. The Tracking Test was first created by psychologists working in the United States Army (Reitan 1955) and is a widely used neuropsychological test. This test requires visuospatial processing and motor skills. It consists of two parts, A and B. Part A evaluates the rate of activation based on visual scanning ability, and part B evaluates the ability to change setup and follow sequencing between sets of stimuli. Part B is more complex and takes longer to complete because it requires more visual-spatial processing than part A. Also, the difficulty level of Part B is higher than Part A because it requires more motor speed, agility and attention. That's why we chose part B of the test for this research. Participants first make a short sample of the test. Then comes the actual test.
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 27 Dec 2024.
- Background: PubMed 34488379Li L, Liu M, Zeng H, Pan L. Multi-component exercise training improves the physical and cognitive function of the elderly with mild cognitive impairment: a six-month randomized controlled trial. Ann Palliat Med. 2021 Aug;10(8):8919-8929. doi: 10.21037/apm-21-1809.
- Background: PubMed 22929394Langlois F, Vu TT, Chasse K, Dupuis G, Kergoat MJ, Bherer L. Benefits of physical exercise training on cognition and quality of life in frail older adults. J Gerontol B Psychol Sci Soc Sci. 2013 May;68(3):400-4. doi: 10.1093/geronb/gbs069. Epub 2012 Aug 28.
- Individual participant dataSharing planned: Yes. AFTER COMPLETED THE STUDY.
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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.
UGUR CAVLAK, Prof. study director
Biruni University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vestibular based exercise program and calisthenic based exercise program in people with Cognitive Change, run by Biruni 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 3 inclusion and 1 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 27 Dec 2024. 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?
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?
Standardized Mini Mental State Test (SMMT) (time frame: 15 min.). The study lists 4 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 NCT05925582, which also lists 2 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 27 Dec 2024.