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GeriatricNCT07007026

Effects of Immersive Virtual Reality on Physical Function, Fall-Related Outcomes, Fatigue, and Quality of Life in Older Adults

A study testing Immersive Virtual Reality and Traditional Home-based Exercises in people with Geriatric and Virtual Reality, run by Eastern Mediterranean University at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

To investigate the effectiveness of an immersive virtual reality intervention on physical fitness, balance, physical activity level, risk of falling, fear of falling, fatigue, and quality of life in older adults compared to an active control group (ACG). Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Geriatric, Virtual Reality
What is being tested?
Immersive Virtual Reality and Traditional Home-based Exercises
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2024to 30 May 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Individuals over 65 years of age
  • Individuals with a Mini Mental Test score of 24 and above
  • Individuals who can walk independently and do not use assistive devices
  • Individuals who voluntarily agreed to participate in the study

Who cannot join

  • Individuals diagnosed with neurological diseases (Stroke, Parkinson's, Multiple Sclerosis)
  • Individuals with a diagnosis of cardiovascular disease (heart failure, endocarditis, myocarditis, cardiac arrhythmias) diagnosed with psychiatric or cognitive disorders
  • undergone surgical operation in the last 6 months
  • Visual impairment that makes it impossible for them to see virtual reality images
  • Individuals diagnosed with vertigo, epilepsy
  • Individuals diagnosed with cancer

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Eastern Mediterranean University

    Mersin, Northern Cyprus, 99628

Other trials in Turkey (Türkiye)

About this study

Official title: The Effectiveness of an Immersive Virtual Reality Intervention on Physical Fitness, Balance, Fall Risk, Fear of Falling, Fatigue, and Quality of Life in Geriatric Individuals

To investigate the effectiveness of an immersive virtual reality intervention on physical fitness, balance, physical activity level, risk of falling, fear of falling, fatigue, and quality of life in older adults compared to an active control group (ACG).

Read the detailed description

This study aims to investigate the effects of virtual reality intervention on interrelated physical and psychosocial multidimensional parameters such as physical fitness, balance, fall risk, fear of falling, fatigue, and quality of life in older adults.

Being tested
Immersive Virtual Reality, Traditional Home-based Exercises

What participants receive

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

  • Immersive Virtual RealityOther

    The intervention program was implemented over a period of eight weeks, with three ses-sions per week, each lasting 35 minutes.

  • Traditional Home-based ExercisesOther

    The participants were instructed to adhere to the exercise program thrice weekly for a period of eight weeks.

Study groups in NCT07007026
Study groupRoleWhat they receive
Virtual Reality InterventionExperimentalIn the virtual reality intervention group, older adults utilized an Oculus Meta Quest 2 headset (Meta Platforms, Inc., Menlo Park, CA, USA). The Meta Horizon application on the phone facilitated screen mirroring, enabling the observation of the task's progression by reflecting the headset screen. The FIT-XR application, available in the Oculus store, was utilized, and it offers a variety of exercise modes and interfaces, including options for in-door and outdoor scenarios. An exhaustive examination of all exercise modes within the application was conducted to enhance upper and lower extremity muscle strength, weight transfer, stepping, trunk control, endurance, coordination, cognitive functions, and the duration and difficulty level of the exercises. The evaluation process involved a meticu-lous assessment of the suitability of these exercises for elderly individuals. Consequently, the FIT-XR Boxing and FIT-XR Slam exercise modes were selected for utilization in the study.
Receives: Other: Immersive Virtual Reality
Active Control GroupActive comparatorA physiotherapist developed an exercise program for the control group, providing visual and detailed explanations appropriate for older adults and distributing brochures to participants. The participants were instructed to adhere to the exercise program thrice weekly for a period of eight weeks.
Receives: Other: Traditional Home-based Exercises

What is being measured

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

  1. Balance

    Fullerton Advanced Balance Test is a test consisting of ten items in total, including standing with feet together and eyes closed, reaching forward by extending the arm to pick up an object (pen) held at shoulder level, turning 360 degrees in the right and left directions, stepping on and over 15 cm steps, tandem walking, standing on one leg, standing on foam with eyes closed, two-foot jump-ing, walking by turning the head, and reactive postural control. Each item is scored be-tween 0 and 4, with a maximum score of 40. A higher score indicates better balance ability and a lower score indicates poor balance ability.

    Measured: Assessments were conducted before the intervention and at the end of the 8-week inter-vention period. tment at 8 weeks

Secondary outcomes (8)
  1. Physical Activity Level

    The Physical Activity Scale for the Elderly (PASE) was used to assess the physical ac-tivity level of individuals. The scale evaluates the physical activity of elderly individuals in the last week. It includes leisure time activities, housework activities, and work-related physical activity components. It questions the amount of activities such as walking, light, moderate, vigorous sports and recreational activities, strengthening and endurance exercises, work-related activities such as walking and standing, light housework such as gardening and home repairs, and the amount of activities in the last week. The activities in the scale are evaluated according to the intensity and frequency of exercise: light, moderate, and heavy. Activity durations can be marked as less than 1 hour, between 1-2 hours, be-tween 2-4 hours and more than 4 hours. To calculate the total score, activity frequencies and activity weights are multiplied. The scores obtained for each activity are summed to ob

    Measured: Assessments were conducted before the intervention and at the end of the 8-week intervention period.

  2. Physical Fitness

    Senior Fitness Test includes a total of six functional tests assessing muscular strength, flexibility, aerobic endurance, balance and agility. 30-second sit and stand test was used to evaluate the muscle strength of the lower extremity and 30-second weight lifting test was used to evaluate the muscle strength of the upper extremity. Two-minute step test was used to assess aerobic endurance, which involves recording the total number of dominant side steps taken correctly for 2 minutes with a stopwatch. The chair sit-reach test was used to evaluate the flexibility of the lower extremity muscles and the back scratch test was used to evaluate the flexibility of the upper extremities. For the assessment of agility and dynamic balance, eight-step walk test was used, which involved getting up from the chair on com-mand, walking a distance of 2.44 meters without running but as fast as possible, and sit-ting back on the chair by turning around the cylinder ahead.

    Measured: Assessments were conducted before the intervention and at the end of the 8-week intervention period.

  3. Risk of Falling

    Morse Falls Scale is a practical scale that can categorize patients according to their fall risk. It includes a total of six domains: pres-ence of a history of falls, presence of comorbidity, use of assistive devices, intravenous therapy status, transfer/walking and mental status. In the evaluation, fall risk is deter-mined with cut-off scores as suggested by Morse, with 0-24 points being the group with no fall risk, 25-50 points being the group with low fall risk, and 51 and above points being the group with high fall risk.

    Measured: Assessments were conducted before the intervention and at the end of the 8-week inter-vention period. tment at 8 weeks

  4. Fear of Falling

    The International Fall Efficacy Scale (FES-I) is a scale consisting of a total of 16 items with each item ranging from 1-4 points. The mini-mum total score is 16 and the maximum score is 64. A high total score indicates a high fear of falling.

    Measured: Assessments were conducted before the intervention and at the end of the 8-week intervention period.

  5. Fatigue

    FACIT Fatigue Scale, which assesses the level of fatigue in the last seven days, was used to evaluate fatigue. It consists of 13 items in total, with each item scored between 0 and 4. The minimum total score is 0 and the maximum score is 52. The lower the total score, the higher the fatigue level of the individual.

    Measured: Assessments were conducted before the intervention and at the end of the 8-week intervention period.

  6. Life Quality

    World Health Organization Quality of Life Instrument-Older Adults Mod-ule(WHOQOL-Old) sensory functions, autonomy, past, present and future activities, so-cial participation, dying and death, and closeness are the 6 sub-domains and 24 items in total [46]. Each item is scored between 1 and 5 and a minimum of 4 and a maximum of 20 points can be obtained from each sub-domain. At the same time, the total score can be calculated by summing the score values. The maximum total score that can be obtained in the whole scale is 120 and the minimum total score is 24. The higher the total score, the higher the quality of life level of the individual.

    Measured: Assessments were conducted before the intervention and at the end of the 8-week intervention period.

  7. Treatment Satisfaction

    Visual Analog Scale consisting of a 100 mm long horizontal line was used for treat-ment satisfaction assessment. There are two descriptors at the beginning and end of the line indicating extreme satisfaction (not at all satisfied and very satisfied).

    Measured: Assessments were conducted before the intervention and at the end of the 8-week intervention period.

  8. Virtual Reality Sickness

    Virtual Reality Sickness Questionnaire (VRSQ) consists of two components, oculo-motor and disorientation, and 9 items in total.The items are scored on a 4-point scale ranging from 0 to 3 (0=none, 1=mild, 2=moderate, 3=very). The oculomotor impairment component consists of 4 items: general discomfort, fatigue, eye strain and difficulty focus-ing. The disorientation component consisted of 5 items: headache, head fullness, blurred vision, dizziness with eyes closed and vertigo. As a result of the questionnaire, oculomotor, disorientation and total scores are obtained. Oculomotor and disorientation scores are calculated by dividing the individual's component score by the total score obtained (as a percentage). The total score is calculated by the simple average method and a higher score indicates a higher level of movement disorder.

    Measured: Assessments were conducted before the intervention and at the end of the 8-week intervention period.

Timeline

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

  1. First posted5 Jun 2025
  2. Study start1 Dec 2024
  3. Primary completion20 Mar 2025
  4. Study completion30 May 2025 (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
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07007026
Sponsor's protocol ID
SBF00-2024-0128
Status last verified
May 2025
First submitted
14 May 2025
Last updated
5 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Immersive Virtual Reality and Traditional Home-based Exercises in people with Geriatric and Virtual Reality, run by Eastern Mediterranean 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 4 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2025. 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?

This study is still under way. Results are not available in the source record yet.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Balance (time frame: Assessments were conducted before the intervention and at the end of the 8-week inter-vention period. tment at 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 5 Jun 2025.

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