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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05925582
Other study ID # 2022/7614
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date November 15, 2023

Study information

Verified date February 2024
Source Biruni University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date November 15, 2023
Est. primary completion date August 3, 2023
Accepts healthy volunteers No
Gender All
Age group 65 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
vestibular based exercise program
this group's participants will involve in vestibular based exercise program
calisthenic based exercise program
this group's participants will involve in calisthenic based exercise program

Locations

Country Name City State
Turkey Faculty of Health Sciences in Biruni University I?stanbul Zeytinburnu

Sponsors (1)

Lead Sponsor Collaborator
Biruni University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 15 min.
Primary 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. 10 min.
Primary 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. 5 min.
Primary 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. 10 min.
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