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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04166747
Other study ID # N201906048
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date March 30, 2020

Study information

Verified date October 2020
Source Taipei Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 30, 2020
Est. primary completion date January 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 95 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Taiwan Taipei Medical University Taipei Taipei City

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

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