NCT04166747

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 18, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

4 months

First QC Date

November 14, 2019

Last Update Submit

October 5, 2020

Conditions

Keywords

virtual realityolder populationfunctional fitnessquality of lifehappiness

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

The participants in this group will not receive virtual reality based intervention for six weeks.

Interventions

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.

Intervention Group

Eligibility Criteria

Age60 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Medical University

Taipei, Taipei City, 11031, Taiwan

Location

Related Publications (1)

  • 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.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Intervention study with 2 parallel arms
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 14, 2019

First Posted

November 18, 2019

Study Start

October 1, 2019

Primary Completion

January 31, 2020

Study Completion

March 30, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations