Effect of the Virtual Reality Training in Elderly

September 20, 2023 updated by: Oznur Fidan, Eskisehir Osmangazi University

Effect of the Group-based Virtual Reality Training on Activities of Daily Living in Elderly: a Randomized Controlled Trial

The study aims to investigate the efficacy of group-based exercises using virtual reality on activities of daily living in elderly population.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

As a result of morphological and functional changes that occur with aging, complications such as decrease in muscle mass, flexibility and muscle strength, decrease in sleep quality, social isolation and chronic diseases develop and cause a decrease in independence in activities of daily living (ADL). Increasing physical activity in the elderly is effective in maintaining general health status and maintaining independence during activities of daily living (ADL). However, the level of the participation to physical activities is quite low in old age. It's known that group-based exercises and technology-supported exercise training with virtual reality games increase participation in physical activity and improve motor functions and ADL. But, there is no study examining the effect of technology-supported group exercises on ADLs in the elderly. Therefore, the aim of our study is to find out the effects of technology-supported group exercises on ADLs in the elderly over 65 years of age.

The forty-two participants will be recruited and divided into three equal groups randomly. The group 1(n=14) will perform group-based virtual reality training and group 2(n=14) will receive individual virtual reality training for 45-minutes, twice a week for eight weeks. The third group group 3(n=14) will determined as the control group and they will continue their routine daily activities. Primary outcome measure will be Barthel Index of Activities of Daily Living. Secondary outcome measures will be Physical Activity Scale for the Elderly (PASE), Timed Up and Go (TUG) test, Single Leg Stance Test (SLST), Six Minute Walk Test, Geriatric Depression Scale (GDS), Physical Activity Enjoyment Scale (Paces).

Study Type

Interventional

Enrollment (Estimated)

42

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 Locations

  • Turkey
      • Eskişehir, Turkey, 26040
        • Osmangazi University
        • Contact:

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participants who are 65 age or older
  • can ambulate independently

Exclusion Criteria:

  • elderly individuals who are suffering from any acute or unstable illness or medical condition
  • elderly individuals who are unable to understand the treatment protocol.
  • elderly individuals who are suffering from any kind of visual, auditory and neural or vestibular system disorders.
  • History of surgery in the last 6 months

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- based virtual reality training
Individuals in this arm will be received intervention protocol of group- based virtual reality training program in which total 16-sessions were given for twice a week for eight weeks for 45-minutes.
Other: virtual reality
14 elderly participants receive intervention protocol of group- based virtual reality training program (XBOX Kinect games: Your Shape: Fitness Evolved) in which total 16-sessions were given for twice a week for eight weeks for 45-minutes.
Experimental: Individual virtual reality training
Individuals in this arm will be received intervention protocol of individual virtual reality training program in which total 16-sessions were given for twice a week for eight weeks for 45-minutes.
Other: Virtual reality
14 elderly participants receive intervention protocol of individual virtual reality training program (XBOX Kinect games: Your Shape: Fitness Evolved) in which total 16-sessions were given for twice a week for eight weeks for 45-minutes.
No Intervention: Control group
Individuals in this arm will continue their routine daily activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barthel Index for Activities of Daily Living
Time Frame: 8 weeks
The Barthel Index, measures the extent to which somebody can function independently and has mobility in their activities of daily living (ADL) i.e. feeding, bathing, grooming, dressing, bowel control, bladder control, toileting, chair transfer, ambulation and stair climbing. Total scores range from 0 - 20, with lower scores indicating increased disability.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed Up and Go (TUG)
Time Frame: 8 weeks
Time Up and Go is a very simple, quick, valid, reliable and an objective test which is used for the assessment of balance and mobility.
8 weeks
Single Leg Stance Test (SLST)
Time Frame: 8 weeks
Single Leg Stance Test (SLST) test is used to assess balance. For the test, volunteers were asked to lift one foot without touching the support leg.
8 weeks
Six minute walk test
Time Frame: 8 weeks
Six minute walk test is used to assessment of walking related performance fatigability
8 weeks
Physical Activity Scale for the Elderly
Time Frame: 8 weeks
Physical Activity Scale for the Elderly is a brief (5 minutes) and easily scored survey designed specifically to assess physical activity in epidemiological studies of person age 65 years and older. The total score ranges from 0 to 400 or more and high scores show better physical activity levels.
8 weeks
Geriatric Depression Scale
Time Frame: 8 weeks
This instrument evaluate depressive symptoms using yes/no answers. Of the 15 items, 10 indicate the presence of depression when answered positively while the other 5 are indicative of depression when answered negatively
8 weeks
Physical Activity Enjoyment Scale (Paces)
Time Frame: 8 weeks
This scale measures enjoyment during physical activity through with 5 items from the original18 items.
8 weeks
Mini Mental State Test
Time Frame: Baseline
Mini Mental State Test,30-point test, will be used for cognitive assessment.A score of 23 or lower is indicative of cognitive impairment.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eskisehir Osmangazi University

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 (Estimated)

January 1, 2024

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

January 19, 2023

First Submitted That Met QC Criteria

January 19, 2023

First Posted (Actual)

January 30, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Gazi University

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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