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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Virtual Reality; Geriatric
• Intervention / Treatment: Other: Immersive Virtual Reality; Other: Traditional Home-based Exercises

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Northern Cyprus
    • Mersin, Northern Cyprus, Turkey, 99628
      • Eastern Mediterranean University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality Intervention; 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.	Other: Immersive Virtual Reality; The intervention program was implemented over a period of eight weeks, with three ses-sions per week, each lasting 35 minutes.
Active Comparator: Active Control Group; 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.	Other: Traditional Home-based Exercises; The participants were instructed to adhere to the exercise program thrice weekly for a period of eight weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Assessments were conducted before the intervention and at the end of the 8-week inter-vention period. tment at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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.	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.	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.	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.	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).	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.	Assessments were conducted before the intervention and at the end of the 8-week intervention period.

Collaborators and Investigators

• Sponsor: Eastern Mediterranean University
• Investigators: Study Director: Ender Angın Associate Professor Doctor, Eastern Mediterranean University; Study Director: Gözde İyigün Associate Professor Doctor, Eastern Mediterranean University; Principal Investigator: Damla Parmak, Eastern Mediterranean University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Actual): March 20, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: May 14, 2025
• First Submitted That Met QC Criteria: May 27, 2025
• First Posted (Estimated): June 5, 2025

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: May 27, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: SBF00-2024-0128

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No