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Clinical Trials/NCT07007026
NCT07007026Active, not recruitingNot Applicable

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

Eastern Mediterranean University1 site in 1 country44 target enrollmentStarted: December 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
44
Locations
1
Primary Endpoint
Balance

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: Immersive Virtual Reality (Other)

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.

Intervention: Traditional Home-based Exercises (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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