AzTrials
AzTrials

ElderlyNCT05703568

Effect of the Virtual Reality Training in Elderly

A study testing virtual reality in people with Elderly, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Elderly
What is being tested?
virtual reality
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Jan 2024to 1 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Osmangazi University

    Eskişehir, 26040

    Oznur Fidan, +90 222239 37 50, oun@ogu.edu.tr

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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).

Conditions
Elderly
Being tested
virtual reality

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • virtual realityOther

    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 realityOther

    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.

Study groups in NCT05703568
Study groupRoleWhat they receive
Group- based virtual reality trainingExperimentalIndividuals 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.
Receives: Other: virtual reality
Individual virtual reality trainingExperimentalIndividuals 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.
Receives: Other: Virtual reality
Control groupNo interventionIndividuals in this arm will continue their routine daily activities.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 8 weeks

Secondary outcomes (7)

  1. 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.

    Measured: 8 weeks

  2. 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.

    Measured: 8 weeks

  3. 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.

    Measured: 8 weeks

  4. Six minute walk test

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

    Measured: 8 weeks

  5. 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

    Measured: 8 weeks

  6. Physical Activity Enjoyment Scale (Paces)

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

    Measured: 8 weeks

  7. 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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2023
  2. Study start1 Jan 2024 (estimated)
  3. Primary completion1 Feb 2024 (estimated)
  4. Study completion1 Jun 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05703568
Sponsor's protocol ID
Gazi University
Status last verified
Jul 2023
First submitted
19 Jan 2023
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing virtual reality in people with Elderly, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Barthel Index for Activities of Daily Living (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05703568.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in