- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04166747
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
Conditions
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.
Sponsor
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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