Vestibular-Based Exercises vs. Calisthenic Exercises for Cognitive Functions

Sponsor
Biruni University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05925582
Collaborator
(none)
30
1
2
5.5
5.5

Study Details

Study Description

Brief 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.
Condition or Disease Intervention/Treatment Phase
  • Other: vestibular based exercise program
  • Other: calisthenic based exercise program
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Two groups: Interventional (study) group and Control groupTwo groups: Interventional (study) group and Control group
Masking:
Single (Participant)
Masking Description:
None of the participants knows the group they are in.
Primary Purpose:
Treatment
Official Title:
The Effects of Vestibular-Based Exercises and Calisthenic Exercises on Cognitive Functions in Older Individuals: A Randomized Controlled Trial
Actual Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Aug 3, 2023
Anticipated Study Completion Date :
Nov 15, 2023

Arms and Interventions

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.

Other: vestibular based exercise program
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.

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

Outcome Measures

Primary Outcome Measures

  1. Standardized Mini Mental State Test (SMMT) [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.

  2. Dual task 1 (Motor + Cognitive) Test [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.

  3. Dual task 2 (Motor + Cognitive) Test [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.

  4. Dual task 3 (Motor + Cognitive) Test [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Health Sciences in Biruni University İ̇stanbul Zeytinburnu Turkey 34010

Sponsors and Collaborators

  • Biruni University

Investigators

  • Study Director: UGUR CAVLAK, Prof., Biruni University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ugur Cavlak, Clinical Professor, Biruni University
ClinicalTrials.gov Identifier:
NCT05925582
Other Study ID Numbers:
  • 2022/7614
First Posted:
Jun 29, 2023
Last Update Posted:
Jul 5, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 5, 2023