- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05925582
Vestibular-Based Exercises vs. Calisthenic Exercises for Cognitive Functions
February 12, 2024 updated by: Ugur Cavlak, Biruni University
The Effects of Vestibular-Based Exercises and Calisthenic Exercises on Cognitive Functions in Older Individuals: 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: UGUR CAVLAK, Prof.
- Phone Number: 00905324519644
- Email: ucavlak@biruni.edu.tr
Study Locations
-
-
Zeytinburnu
-
İ̇stanbul, Zeytinburnu, Turkey, 34010
- Faculty of Health Sciences in Biruni University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- Having an orthopedic, neurological or psychiatric disorder that would prevent the evaluation and exercise program in the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1
All the participants in Group 1 will receive a 8-week vestibular based exercises program 3 times in a week.
|
this group's participants will involve in vestibular based exercise program
|
Active Comparator: Group 2
All the participants in Group 1 will receive a 8-week calistenic based exercises program 3 times in a week.
|
this group's participants will involve in calisthenic based exercise program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
15 min.
|
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.
|
10 min.
|
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.
|
5 min.
|
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.
|
10 min.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: UGUR CAVLAK, Prof., Biruni University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Langlois 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2023
Primary Completion (Actual)
August 3, 2023
Study Completion (Actual)
November 15, 2023
Study Registration Dates
First Submitted
June 22, 2023
First Submitted That Met QC Criteria
June 22, 2023
First Posted (Actual)
June 29, 2023
Study Record Updates
Last Update Posted (Estimated)
February 13, 2024
Last Update Submitted That Met QC Criteria
February 12, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 2022/7614
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
AFTER COMPLETED THE STUDY.
IPD Sharing Time Frame
September 2023
IPD Sharing Access Criteria
free
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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