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).
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
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.
- Conditions
- Geriatric, Virtual Reality
- 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 group | Role | What they receive |
|---|---|---|
| Virtual Reality Intervention | Experimental | In 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 Group | Active comparator | A 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.
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)
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.
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.
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
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.
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.
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.
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.
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.
- First posted5 Jun 2025
- Study start1 Dec 2024
- Primary completion20 Mar 2025
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GeriatricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ender Angın Associate Professor Doctor, Study director, Eastern Mediterranean UniversityGözde İyigün Associate Professor Doctor, Study director, Eastern Mediterranean UniversityDamla Parmak, Principal investigator, Eastern Mediterranean University
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07007026
- Acronym / sponsor ID
- SBF00-2024-0128
- Conditions
- Geriatric, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 20 Mar 2025 (actual)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Intervention | Experimental | Other: Immersive Virtual RealityIn 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. |
| Active Control Group | Active comparator | Other: Traditional Home-based ExercisesA 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immersive Virtual RealityThe intervention program was implemented over a period of eight weeks, with three ses-sions per week, each lasting 35 minutes. | Other | Virtual Reality Intervention |
| Traditional Home-based ExercisesThe participants were instructed to adhere to the exercise program thrice weekly for a period of eight weeks. | Other | Active Control Group |
Primary outcome
Balance
Time frame: Assessments were conducted before the intervention and at the end of the 8-week inter-vention period. tment at 8 weeks
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.
8 secondary outcomes
Physical Activity Level
Time frame: Assessments were conducted before the intervention and at the end of the 8-week intervention period.
Physical Fitness
Time frame: Assessments were conducted before the intervention and at the end of the 8-week intervention period.
Risk of Falling
Time frame: Assessments were conducted before the intervention and at the end of the 8-week inter-vention period. tment at 8 weeks
Fear of Falling
Time frame: Assessments were conducted before the intervention and at the end of the 8-week intervention period.
Fatigue
Time frame: Assessments were conducted before the intervention and at the end of the 8-week intervention period.
Life Quality
Time frame: Assessments were conducted before the intervention and at the end of the 8-week intervention period.
Treatment Satisfaction
Time frame: Assessments were conducted before the intervention and at the end of the 8-week intervention period.
Virtual Reality Sickness
Time frame: Assessments were conducted before the intervention and at the end of the 8-week intervention period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ender Angın Associate Professor Doctor study director
Eastern Mediterranean University
Gözde İyigün Associate Professor Doctor study director
Eastern Mediterranean University
Damla Parmak principal investigator
Eastern Mediterranean University
1 site in 1 country: see every site and its status.
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.