NCT05925582

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2023

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

June 22, 2023

Last Update Submit

December 26, 2024

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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.

  • 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.

  • 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.

  • 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.

Study Arms (2)

Group 1

EXPERIMENTAL

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

Group 2

ACTIVE COMPARATOR

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

Interventions

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

Group 1

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

Group 2

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Having an orthopedic, neurological or psychiatric disorder that would prevent the evaluation and exercise program in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Health Sciences in Biruni University

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 34488379BACKGROUND
  • 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.

    PMID: 22929394BACKGROUND

Study Officials

  • UGUR CAVLAK, Prof.

    Biruni University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
None of the participants knows the group they are in.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups: Interventional (study) group and Control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 22, 2023

First Posted

June 29, 2023

Study Start

June 1, 2023

Primary Completion

August 3, 2023

Study Completion

November 15, 2023

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

AFTER COMPLETED THE STUDY.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
September 2023
Access Criteria
free

Locations