Health PromotionNCT05565963
Effectiveness of VR Exercise Intervention on Functional Fitness and Quality of Life Among Elderly
A study testing Virtual reality exercise intervention in people with Health Promotion, run by National Taiwan Normal University at 1 site in Taiwan.
Trial summary
The aim of this study is to determine the effect of virtual reality-based exercise on the intervention and follow-up retention of functional fitness and quality of life among older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Promotion
- What is being tested?
- Virtual reality exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Sep 2020to 30 Mar 2021
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- aged ≥ 65,
- are able to perform daily activities,
- with no past or current history of medical situations found in the Physical Activity Readiness Questionnaire (PAR-Q).
Who cannot join
- being less than 65 years of age,
- being unfit to participate in the study as revealed by the PAR-Q.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to determine the effect of virtual reality-based exercise on the intervention and follow-up retention of functional fitness and quality of life among older adults.
Read the detailed description
In a worldwide survey of fitness trends last 2021, Virtual Reality (VR) training recently took the top 10 spots. In fact, only a few studies were conducted on the retention of functional fitness and quality of life among older people. The main goal of this study was to assess the effects of virtual reality exercise on the functional fitness and quality of life of older adults after 12 weeks of intervention and another 12 weeks of follow-up.
- Conditions
- Health Promotion
- Being tested
- Virtual reality exercise intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality exercise interventionOther
The experimental group received VR exercise sessions for 75-90 minutes, twice a week for a duration of 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group. | Experimental | 12-week intervention, with a 12-week follow-up. Device:1 computer virtual reality online software and 3 large projectors were used to project videos on the wall in a wrap-around state. Receives: Other: Virtual reality exercise intervention |
| Control group. | No intervention | No intervention with a 12 week follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Senior Fitness Test to specify that "a period change" is being assessed.
Senior Fitness Tests were to evaluate the functional fitness of older adults. The test has six items: back scratch (cm), chair sit-and-reach (cm), arm curl, chair stand (times), 2-minute step (times), and 8-foot starting distance (sec). The functional fitness (e.g., back scratch, chair-and-reach, arm curl, chair stand, 2-minute step) of higher scores means better functional fitness.
The functional fitness (e.g., 8-foot starting distance) of higher scores means poorer functional fitness.
This study is a measure to assess change between two-time points.
(1)Change in functional fitness of older adults from 1-week baseline (pre-test) to 12 weeks (i.e., exercise intervention phase). (2) Discontinuation of exercise intervention at 13 (post-test) to 24 weeks (follow-up) and ongoing follow-up of older people's function fitness maintenance outcomes.
Measured: The time points for assessment were week 1 (pre-test), 13 (post-test), and 24 (follow-up).
Quality of Life Test to specify that "a period change" is being assessed.
The WHOQOL-OLD is used to measure the quality of life of older adults. This questionnaire is comprised of 24 items divided into six domains, with each domain having four items. These domains include sensory abilities, autonomy, response to the past present, and future activities, social participation, response to death and dying, and response to intimacy. Responses were rated on a Likert scale, with a 1-5-point scale for each item. The result with the highest total score indicates a greater quality of life.
This study is a measure to assess changes between two-time points.
(1) Change in self-perceived quality of life from 1-week baseline (pre-test) to 12 weeks (i.e., exercise intervention phase). (2) Discontinuation of exercise intervention at 13 (post-test) to 24 weeks (follow-up) and ongoing follow-up of older people's self-perceived quality of life maintenance outcomes.
Measured: Measured at week 1 (pre-test), 13 (post-test), and 24 (follow-up).
Secondary outcomes (2)
Body mass index (BMI)
Measure older adults of height by attaching cloth ruler tape to the wall (units of measurement: cm). The weight of the elderly is measured using commercially available electronic weighing machines. (weight and height will be combined to report BMI in kg/m2).
Measured: Measured at week 1(pre-test).
International Physical Activity Questionnaire (IPAQ-LV).
Physical activity was chosen through the Taiwanese version of the IPAQ-LV. Results were determined by first understanding how much total time was spent on physical activity. This was then multiplied by the frequency of the activity (i.e., per week and per day). The purpose of this was to evaluate the difference in physical activity of participants.
Measured: Measured at week 1(pre-test).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start20 Sep 2020
- Primary completion27 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health PromotionStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Szu-Hsien Lee, Study director, Research Ethics Committee, National Taiwan University, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565963
- Sponsor's protocol ID
- litingwang_2
- Status last verified
- Sep 2022
- First submitted
- 23 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of VR Exercise Intervention on Functional Fitness and Quality of Life Among Elderly
- ClinicalTrials.gov ID
- NCT05565963
- Acronym / sponsor ID
- litingwang_2
- Conditions
- Health Promotion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 27 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 4 Oct 2022 (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 aim of this study is to determine the effect of virtual reality-based exercise on the intervention and follow-up retention of functional fitness and quality of life among older adults.
Detailed description
In a worldwide survey of fitness trends last 2021, Virtual Reality (VR) training recently took the top 10 spots. In fact, only a few studies were conducted on the retention of functional fitness and quality of life among older people. The main goal of this study was to assess the effects of virtual reality exercise on the functional fitness and quality of life of older adults after 12 weeks of intervention and another 12 weeks of follow-up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group. | Experimental | Other: Virtual reality exercise intervention12-week intervention, with a 12-week follow-up. Device:1 computer virtual reality online software and 3 large projectors were used to project videos on the wall in a wrap-around state. |
| Control group. | No intervention | –No intervention with a 12 week follow-up. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- aged ≥ 65,
- are able to perform daily activities,
- with no past or current history of medical situations found in the Physical Activity Readiness Questionnaire (PAR-Q).
Key exclusion criteria (2 listed)
- being less than 65 years of age,
- being unfit to participate in the study as revealed by the PAR-Q.
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 exercise interventionThe experimental group received VR exercise sessions for 75-90 minutes, twice a week for a duration of 12 weeks. | Other | Intervention group. |
Primary outcome
Senior Fitness Test to specify that "a period change" is being assessed.
Time frame: The time points for assessment were week 1 (pre-test), 13 (post-test), and 24 (follow-up).
Senior Fitness Tests were to evaluate the functional fitness of older adults. The test has six items: back scratch (cm), chair sit-and-reach (cm), arm curl, chair stand (times), 2-minute step (times), and 8-foot starting distance (sec). The functional fitness (e.g., back scratch, chair-and-reach, arm curl, chair stand, 2-minute step) of higher scores means better functional fitness. The functional fitness (e.g., 8-foot starting distance) of higher scores means poorer functional fitness. This study is a measure to assess change between two-time points. (1)Change in functional fitness of older adults from 1-week baseline (pre-test) to 12 weeks (i.e., exercise intervention phase). (2) Discontinuation of exercise intervention at 13 (post-test) to 24 weeks (follow-up) and ongoing follow-up of older people's function fitness maintenance outcomes.
Quality of Life Test to specify that "a period change" is being assessed.
Time frame: Measured at week 1 (pre-test), 13 (post-test), and 24 (follow-up).
The WHOQOL-OLD is used to measure the quality of life of older adults. This questionnaire is comprised of 24 items divided into six domains, with each domain having four items. These domains include sensory abilities, autonomy, response to the past present, and future activities, social participation, response to death and dying, and response to intimacy. Responses were rated on a Likert scale, with a 1-5-point scale for each item. The result with the highest total score indicates a greater quality of life. This study is a measure to assess changes between two-time points. (1) Change in self-perceived quality of life from 1-week baseline (pre-test) to 12 weeks (i.e., exercise intervention phase). (2) Discontinuation of exercise intervention at 13 (post-test) to 24 weeks (follow-up) and ongoing follow-up of older people's self-perceived quality of life maintenance outcomes.
2 secondary outcomes
Body mass index (BMI)
Time frame: Measured at week 1(pre-test).
International Physical Activity Questionnaire (IPAQ-LV).
Time frame: Measured at week 1(pre-test).
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 4 Oct 2022.
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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.
Szu-Hsien Lee study director
Research Ethics Committee, National Taiwan University, Taiwan
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 exercise intervention in people with Health Promotion, run by National Taiwan Normal 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 3 inclusion and 2 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 4 Oct 2022. 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?
Senior Fitness Test to specify that "a period change" is being assessed. (time frame: The time points for assessment were week 1 (pre-test), 13 (post-test), and 24 (follow-up).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2022.