Functional FitnessNCT05582863
Effects of a 12-week VR Intervention on the Functional Fitness of Adults of Different Age Ranges
A study testing Virtual reality exercise intervention in people with Functional Fitness and Virtual Reality, run by National Taiwan Normal University at 1 site in Taiwan.
Trial summary
This study aimed to evaluate the effects of a 12-week VR fitness intervention on the functional fitness of adults of different age ranges. Read more about this study
- Who is it for?
- Ages 65 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Functional Fitness, Virtual Reality
- What is being tested?
- Virtual reality exercise intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTaiwan
- Study dates
- 4 Aug 2020to 10 Feb 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 to 84 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- aged more 65 and less 84 years
- with no listening/vision impairments
- who did not have any history of illness based on their response to the Physical Activity Readiness Questionnaire (PAR-Q)
- interested in the virtual reality exercise
Who cannot join
- age less than 65 or more than 84 years
- disability and unable to live independently
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a 12-week Virtual Reality-based Fitness Intervention on the Functional Fitness of Adults of Different Age Ranges
This study aimed to evaluate the effects of a 12-week VR fitness intervention on the functional fitness of adults of different age ranges.
Read the detailed description
Previous studies have shown age-related decreases in physical activity and functional fitness among older adults. Virtual Reality (VR) exercise programs are currently used in leisure and entertainment to improve the physical health of older adults. However, VR exercise in assessing physical health or functional fitness in older adults of different age ranges is rare. To fill this research gap, VR exercise was to assess functional fitness improvement in young and middle-aged participants.
- Conditions
- Functional Fitness, Virtual Reality
- Being tested
- Virtual reality exercise intervention
- Keywords
- Virtual reality, Exercise, Old adults
- Medical subject headings
- Motor Activity
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 performed a 75-90-minute VR exercise routine twice a week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group. | Experimental | The experimental group attended a VR exercise routine twice a week for 12 weeks.
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 | Participants in the control group received no intervention and had normal daily activites. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Senior Fitness Test
The Senior Fitness Test was used to assess the functional fitness of the participants. The test has six items and evaluations of four physical functional dimensions using the following movements: Back scratch was assessed for upper body flexibility (units of measurement: cm). Chair sit-and-reach movement evaluates lower body flexibility (cm). Arm curl movement assesses upper body strength (times). Chair-stand test evaluates lower body muscle strength (times). 2-minute step exercise evaluates cardiorespiratory fitness (times). 8-foot up-and-go evaluates balance and agility, (sec).
The back scratch, chair-and-reach, arm curl, chair stand, and 2-minute step of higher scores mean better functional fitness. The 8-foot up-and-go of higher scores means poorer functional fitness.
The study measures the change in functional fitness of older adults from a 1-week baseline to 12 weeks (i.e., exercise intervention phase).
Measured: Senior Functional fitness to specify a period "change" is being assessed. The time points for assessment were week 1 (pre-test), and 12 (post-test).
Secondary outcomes (1)
Weight and Kilograms test
Measure older adults of height by attaching cloth ruler tape to the wall (e.g., height in centimeters).
The weight of the elderly is measured using commercially available electronic weighing machines. (e.g., weight in kilograms).
The height and weight measurements of older people are aggregated to produce a reported value (e.g., weight and height will be combined to report BMI in kg/m2).
Measured: Not assessing change.The test was only a one-time measure 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 posted17 Oct 2022
- Study start4 Aug 2020
- Primary completion6 Feb 2021
- Study completion10 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional FitnessStudies 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lee Szu-Hsien, Study director, Research Ethics Committee, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05582863
- Sponsor's protocol ID
- litingwang_1
- Status last verified
- Oct 2022
- First submitted
- 23 Sep 2022
- Last updated
- 17 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 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 12-week Virtual Reality-based Fitness Intervention on the Functional Fitness of Adults of Different Age Ranges
- ClinicalTrials.gov ID
- NCT05582863
- Acronym / sponsor ID
- litingwang_1
- Conditions
- Functional Fitness, Virtual Reality
- Keywords
- Virtual reality, Exercise, Old adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 6 Feb 2021 (actual)
- Study completion
- 10 Feb 2021 (actual)
- First posted
- 17 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.
This study aimed to evaluate the effects of a 12-week VR fitness intervention on the functional fitness of adults of different age ranges.
Detailed description
Previous studies have shown age-related decreases in physical activity and functional fitness among older adults. Virtual Reality (VR) exercise programs are currently used in leisure and entertainment to improve the physical health of older adults. However, VR exercise in assessing physical health or functional fitness in older adults of different age ranges is rare. To fill this research gap, VR exercise was to assess functional fitness improvement in young and middle-aged participants.
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 interventionThe experimental group attended a VR exercise routine twice a week for 12 weeks. 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 | –Participants in the control group received no intervention and had normal daily activites. |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- aged more 65 and less 84 years
- with no listening/vision impairments
- who did not have any history of illness based on their response to the Physical Activity Readiness Questionnaire (PAR-Q)
- interested in the virtual reality exercise
Key exclusion criteria (2 listed)
- age less than 65 or more than 84 years
- disability and unable to live independently
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 performed a 75-90-minute VR exercise routine twice a week for 12 weeks. | Other | Intervention group. |
Primary outcome
Senior Fitness Test
Time frame: Senior Functional fitness to specify a period "change" is being assessed. The time points for assessment were week 1 (pre-test), and 12 (post-test).
The Senior Fitness Test was used to assess the functional fitness of the participants. The test has six items and evaluations of four physical functional dimensions using the following movements: Back scratch was assessed for upper body flexibility (units of measurement: cm). Chair sit-and-reach movement evaluates lower body flexibility (cm). Arm curl movement assesses upper body strength (times). Chair-stand test evaluates lower body muscle strength (times). 2-minute step exercise evaluates cardiorespiratory fitness (times). 8-foot up-and-go evaluates balance and agility, (sec). The back scratch, chair-and-reach, arm curl, chair stand, and 2-minute step of higher scores mean better functional fitness. The 8-foot up-and-go of higher scores means poorer functional fitness. The study measures the change in functional fitness of older adults from a 1-week baseline to 12 weeks (i.e., exercise intervention phase).
1 secondary outcome
Weight and Kilograms test
Time frame: Not assessing change.The test was only a one-time measure 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 17 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.
Lee Szu-Hsien study director
Research Ethics Committee, National Taiwan University
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 Functional Fitness and Virtual Reality, 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 4 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 17 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 (time frame: Senior Functional fitness to specify a period "change" is being assessed. The time points for assessment were week 1 (pre-test), and 12 (post-test).). 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 17 Oct 2022; AzTrials last refreshed its copy on 6 Nov 2026.