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

Not Applicable

Active, not recruiting

• Conditions: Geriatric; Virtual Reality

• Registration Number: NCT07007026
• Lead Sponsor: Eastern Mediterranean University

Brief 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).

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 Timeline

• Study Start: 2024-12-01
• Primary Completion: 2025-03-20
• Status Verified: 2025-05
• Study First Submitted: 2025-05-14
• Study First Submitted QC: 2025-05-27
• Last Update Submitted: 2025-05-27
• Study Completion: 2025-05-30
• Study First Posted: 2025-06-05
• Last Update Posted: 2025-06-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Balance	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.

Secondary Outcome Measures

Name	Time	Method
Physical Activity Level	Assessments were conducted before the intervention and at the end of the 8-week intervention period.	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
Physical Fitness	Assessments were conducted before the intervention and at the end of the 8-week intervention period.	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.
Risk of Falling	Assessments were conducted before the intervention and at the end of the 8-week inter-vention period. tment at 8 weeks	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.
Fear of Falling	Assessments were conducted before the intervention and at the end of the 8-week intervention period.	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.
Fatigue	Assessments were conducted before the intervention and at the end of the 8-week intervention period.	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.
Life Quality	Assessments were conducted before the intervention and at the end of the 8-week intervention period.	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.
Treatment Satisfaction	Assessments were conducted before the intervention and at the end of the 8-week intervention period.	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).
Virtual Reality Sickness	Assessments were conducted before the intervention and at the end of the 8-week intervention period.	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.

Trial Locations

Locations (1)

Eastern Mediterranean University; 🇹🇷 Mersin, Northern Cyprus, Turkey