Effect of Virtual Reality on Functional Fitness and Quality of Life of Older Population

October 5, 2020 updated by: Shabbir Syed Abdul, Taipei Medical University

Effect of Virtual Reality Based Intervention on Functional Fitness and Quality of Life of Older Population: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Taipei City
      • Taipei, Taipei City, Taiwan, 11031
        • Taipei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
The participants in this group will receive virtual reality based intervention for 15 minutes at a time, twice in a week for six weeks.
Participants will receive virtual reality based experience and will be assessed for its influence on happiness, functional fitness components and quality of life of older age groups.
No Intervention: Control Group
The participants in this group will not receive virtual reality based intervention for six weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of Quality of life
Time Frame: At enrollment and at 6 weeks after enrollment
Comparison of changes in the quality of life through the questionnaire EQ-5D-3L
At enrollment and at 6 weeks after enrollment
Measurement of functional fitness components
Time Frame: At enrollment and at 6 weeks after enrollment
Comparison of changes in the muscle strength through the functional fitness tests.
At enrollment and at 6 weeks after enrollment
Measurement of Happiness
Time Frame: At enrollment and at 6 weeks after enrollment
Comparison of changes in the happiness through the questionnaire mini version of Chinese Happiness Inventory.
At enrollment and at 6 weeks after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

January 31, 2020

Study Completion (Actual)

March 30, 2020

Study Registration Dates

First Submitted

November 14, 2019

First Submitted That Met QC Criteria

November 14, 2019

First Posted (Actual)

November 18, 2019

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 5, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • N201906048

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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