Effect of the Virtual Reality Training in Elderly

Elderly Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05703568
• Other study ID #: Gazi University
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: June 1, 2024

Study information

• Verified date: July 2023
• Source: Eskisehir Osmangazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: June 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elderly

Intervention

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.
• 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.

Locations

Country	Name	City	State
Turkey	Osmangazi University	Eskisehir

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Barthel Index for Activities of Daily Living	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	Physical Activity Scale for the Elderly	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
Secondary	Timed Up and Go (TUG)	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
Secondary	Single Leg Stance Test (SLST)	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
Secondary	Six minute walk test	Six minute walk test is used to assessment of walking related performance fatigability	8 weeks
Secondary	Geriatric Depression Scale	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
Secondary	Physical Activity Enjoyment Scale (Paces)	This scale measures enjoyment during physical activity through with 5 items from the original18 items.	8 weeks
Secondary	Mini Mental State Test	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