Effect of the Virtual Reality Training in Elderly

Sponsor
Eskisehir Osmangazi University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05703568
Collaborator
(none)
42
1
3
4.9
8.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: virtual reality
  • Other: Virtual reality
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Each participant will be requested to draw either number one, number two or number three from a box. Number one will be allocated to group 1, number two will be allocated o group 2 and number two will be allocated o group 3. The group 1 consists of 14 elderly participants who 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. The group 2 consists of 14 elderly participants who received intervention protocol of individual virtual reality training in which total 16-sessions were given for twice a week for eight weeks for 45-minutes. The group 3 consists of 14 elderly participants will continue their routine daily activities.Each participant will be requested to draw either number one, number two or number three from a box. Number one will be allocated to group 1, number two will be allocated o group 2 and number two will be allocated o group 3. The group 1 consists of 14 elderly participants who 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. The group 2 consists of 14 elderly participants who received intervention protocol of individual virtual reality training in which total 16-sessions were given for twice a week for eight weeks for 45-minutes. The group 3 consists of 14 elderly participants will continue their routine daily activities.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of the Group-based Virtual Reality Training on Activities of Daily Living in Elderly: a Randomized Controlled Trial
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Barthel Index for Activities of Daily Living [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.

Secondary Outcome Measures

  1. Physical Activity Scale for the Elderly [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.

  2. Timed Up and Go (TUG) [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.

  3. Single Leg Stance Test (SLST) [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.

  4. Six minute walk test [8 weeks]

    Six minute walk test is used to assessment of walking related performance fatigability

  5. Geriatric Depression Scale [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

  6. Physical Activity Enjoyment Scale (Paces) [8 weeks]

    This scale measures enjoyment during physical activity through with 5 items from the original18 items.

  7. Mini Mental State Test [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Osmangazi University Eskişehir Turkey 26040

Sponsors and Collaborators

  • Eskisehir Osmangazi University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Oznur Fidan, Principal investigator, Eskisehir Osmangazi University
ClinicalTrials.gov Identifier:
NCT05703568
Other Study ID Numbers:
  • Gazi University
First Posted:
Jan 30, 2023
Last Update Posted:
Jan 31, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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 Jan 31, 2023