AgingNCT04166747
Effect of Virtual Reality on Functional Fitness and Quality of Life of Older Population
A study testing Virtual Reality experience in people with Aging and Happiness, run by Taipei Medical University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 60 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Happiness, Quality of Life
- What is being tested?
- Virtual Reality experience
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2019to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Aging, Happiness, Quality of Life
- Being tested
- Virtual Reality experience
- Keywords
- virtual reality, older population, functional fitness, quality of life, happiness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality experienceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Virtual Reality experience |
| Control Group | No intervention | The participants in this group will not receive virtual reality based intervention for six weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Quality of life
Comparison of changes in the quality of life through the questionnaire EQ-5D-3L
Measured: 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.
Measured: 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.
Measured: At enrollment and at 6 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start1 Oct 2019
- Primary completion31 Jan 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention study with 2 parallel arms
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shabbir Syed Abdul, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166747
- Sponsor's protocol ID
- N201906048
- Status last verified
- Oct 2020
- First submitted
- 14 Nov 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33280934
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality Based Intervention on Functional Fitness and Quality of Life of Older Population: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04166747
- Acronym / sponsor ID
- N201906048
- Conditions
- Aging, Happiness, Quality of Life
- Keywords
- virtual reality, older population, functional fitness, quality of life, happiness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention study with 2 parallel arms
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Virtual Reality experienceThe participants in this group will receive virtual reality based intervention for 15 minutes at a time, twice in a week for six weeks. |
| Control Group | No intervention | –The participants in this group will not receive virtual reality based intervention for six weeks. |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality experienceParticipants 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. | Other | Intervention Group |
Primary outcome
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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 33280934Barsasella 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality experience in people with Aging and Happiness, run by Taipei Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Quality of life (time frame: At enrollment and at 6 weeks after enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04166747, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.