Clinical trial NCT05703568: Effect of the Virtual Reality Training in Elderly
Official title: Effect of the Group-based Virtual Reality Training on Activities of Daily Living in Elderly: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Elderly
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 42
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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

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).

Eligibility criteria: 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

Primary outcomes:
measure: Barthel Index for Activities of Daily Living
timeFrame: 8 weeks
Secondary outcomes:
measure: Physical Activity Scale for the Elderly
timeFrame: 8 weeks
measure: Timed Up and Go (TUG)
timeFrame: 8 weeks
measure: Single Leg Stance Test (SLST)
timeFrame: 8 weeks
measure: Six minute walk test
timeFrame: 8 weeks
measure: Geriatric Depression Scale
timeFrame: 8 weeks
measure: Physical Activity Enjoyment Scale (Paces)
timeFrame: 8 weeks
measure: Mini Mental State Test
timeFrame: Baseline
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Osmangazi University
Study officials:
References: