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

Sponsor

Taipei Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT04166747

Collaborator

(none)

Enrollment

Location

Arms

5.9

Actual Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Aging Happiness Quality of Life	Other: Virtual Reality experience	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Intervention study with 2 parallel armsIntervention study with 2 parallel arms

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Oct 1, 2019

Actual Primary Completion Date :

Jan 31, 2020

Actual Study Completion Date :

Mar 30, 2020

Arms and Interventions

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.	Other: Virtual Reality experience 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.

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.

Other: Virtual Reality experience

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 95 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Medical University	Taipei	Taipei City	Taiwan	11031

Sponsors and Collaborators

Taipei Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Shabbir Syed Abdul, Associate Professor, Taipei Medical University

ClinicalTrials.gov Identifier:

NCT04166747

Other Study ID Numbers:

N201906048

First Posted:

Nov 18, 2019

Last Update Posted:

Oct 8, 2020

Last Verified:

Oct 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Shabbir Syed Abdul, Associate Professor, Taipei Medical University

Study Results

No Results Posted as of Oct 8, 2020