Clinical trial NCT04166747: Effect of Virtual Reality on Functional Fitness and Quality of Life of Older Population
Official title: Effect of Virtual Reality Based Intervention on Functional Fitness and Quality of Life of Older Population: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Happiness
Quality of Life
Keywords: virtual reality
older population
functional fitness
quality of life
happiness
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention study with 2 parallel arms
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess the influence of virtual reality (VR) on the different parameters, happiness, quality of life and functional fitness, among older population. The study aims to conduct a randomized controlled trial, where the participants in intervention group will use VR and those in control group do not use VR.

Detailed description: This study aims to conduct a randomized control trial, on 60 older age group participants, and perform the functional fitness test based on the protocol developed by Rikli and Jones, before and after the VR intervention. The functional fitness tests include evaluation of upper body strength, lower body strength, cardiorespiratory endurance, upper body flexibility test, lower body flexibility test, balance, agility test. They will be randomly assigned to the intervention group, receiving the VR program, and the control group who will not receive the VR program. The participants in the intervention group will be asked to use the VR device for 15 minutes, twice a week for 6 weeks, along with their daily routine activities. Control group will carry out the daily routine activities, without the intervention. The change in the quality of life (QOL) and happiness, for both control and intervention groups, will be assessed through EuroQol 5 dimensions 3 level questionnaire (EQ-5D-3L), mini version of Chinese happiness Inventory questionnaire, respectively, to filled at recruitment and follow-up after 6 weeks. The effect of the VR programs will be determined by the comparison of performance, for the functional fitness tests before and after the intervention and also, for the differences between the control and intervention groups

Eligibility criteria: Inclusion Criteria:

* Participants aged 60 years or older and approach TMU aging center.
* Able to understand Mandarin Chinese.
* Gives informed consent to participate
* No past or current history of serious medical disease
* Ability to perform activities of daily living
* Understands the intent of the study

Exclusion Criteria:

* Participants aged below 60 years of age.
* Not able to understand Mandarin Chinese.
* Does not gives informed consent to participate
* Past or current history of serious medical disease
* Inability to perform activities of daily living
* Does not understand the intent of the study

Primary outcomes:
measure: Measurement of Quality of life
timeFrame: At enrollment and at 6 weeks after enrollment
measure: Measurement of functional fitness components
timeFrame: At enrollment and at 6 weeks after enrollment
measure: Measurement of Happiness
timeFrame: At enrollment and at 6 weeks after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
state: Taipei City
Study officials:
References:
citation: Barsasella D, Liu MF, Malwade S, Galvin CJ, Dhar E, Chang CC, Li YJ, Syed-Abdul S. Effects of Virtual Reality Sessions on the Quality of Life, Happiness, and Functional Fitness among the Older People: A Randomized Controlled Trial from Taiwan. Comput Methods Programs Biomed. 2021 Mar;200:105892. doi: 10.1016/j.cmpb.2020.105892. Epub 2020 Nov 29.