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

NCT07007026 | Active Not Recruiting

• 1 other identifier: SBF00-2024-0128
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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).

Conditions

Geriatric; Virtual Reality

Outcome Measures

Primary Outcomes (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.

  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

  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.

Study Arms (2)

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.

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.

Other: Traditional Home-based Exercises

Interventions

Immersive Virtual Reality OTHER

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

Virtual Reality Intervention

Traditional Home-based Exercises OTHER

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

Active Control Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Study Sites (1)

Eastern Mediterranean University

Mersin, Northern Cyprus, 99628, Turkey (Türkiye)

Location

Study Officials

• Ender Angın Associate Professor Doctor

  Eastern Mediterranean University

  STUDY DIRECTOR

• Gözde İyigün Associate Professor Doctor

  Eastern Mediterranean University

  STUDY DIRECTOR

• Damla Parmak

  Eastern Mediterranean University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: June 5, 2025
• Study Start: December 1, 2024
• Primary Completion: March 20, 2025
• Study Completion: May 30, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)