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Virtual RealityNCT06216236

Effects of Physical Fitness Using a Kinect Interventional System

A study testing Kinect intervention system combined with aerobic exercise training and aerobic dance training in people with Virtual Reality and Physical Fitness, run by Wan-Yun Huang at 2 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Kinect intervention system combined with aerobic exercise training can improve the quality of life of older adults in the community, standardize behavior regulation in exercise and improve fitness enthusiasm. Aerobic exercise training using the Kinect intervention system was more effective than traditional training Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Virtual Reality, Physical Fitness
What is being tested?
Kinect intervention system combined with aerobic exercise training and aerobic dance training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
2 sitesTaiwan
Study dates
3 Feb 2024to 3 Dec 2025
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • (1) individuals \>60 years old who live in the community; (2) use of the SOF scale for frailty to evaluate the three assessments, any one of which satisfy the \"pre-frailty\" criteria; (3) able to walk independently for 5 minutes, regardless if they need a walking aid; and (4) medication usage has been stable in the past month.

Who cannot join

  • (1) those with psychiatric diseases or comorbidities based on the DSM-IV criteria and had psychiatric comorbidities (e.g., major depressive disorder); (2) clinically diagnoses of dementia (dementia) or other severe cognitive impairments (Mini-Mental State Examination score \<24 points); and (3) other neurological, orthopedic, and unstable diseases.

Trial locations and contacts

2 sites in 1 country.

Taiwan2 sites
  • Kaohsiung Veterans General Hospital

    Kaohsiung City, 813

  • National Cheng Kung University

    Tainan

Other trials in Taiwan

About this study

Official title: Effects of Physical Fitness Using a Kinect Interventional System for Pre-frail Community-dwelling Elderly Adults

The Kinect intervention system combined with aerobic exercise training can improve the quality of life of older adults in the community, standardize behavior regulation in exercise and improve fitness enthusiasm.

Aerobic exercise training using the Kinect intervention system was more effective than traditional training

Read the detailed description

3.3.1 Participants The subjects of this study are the elderly from the community care center in Kaohsiung City. Our goal is to recruit two groups with 30 subjects in each group, making it a total of 60 subjects. The recruitment method of this study is to upload poster advertisements in the community and the bulletin board of Kaohsiung Veterans General Hospital to recruit subjects. The purpose is to select those who meet the criteria and agree to participate in the research. Eligible subjects must sign a human experiment consent form approved by the Human Experiment Committee of Kaohsiung Veterans General Hospital.

Recruitment of subjects must meet the following standard conditions: (1) elders over the age of 65 living in the community; (2) those who use the frailty SOF scale to evaluate any of the three assessments, with the answer being \"yes\" for any of them (pre frailty) (given in Appendix 1); (3) able to walk independently for five minutes regardless of mobility aids; (4) drug stability in the past one month.

The exclusion criteria is as follows: (1) Those who meet the DSM-IV criteria and have psychiatric comorbidities (for example, major depression); (2) Clinically diagnosed with dementia (Dementia) or other severe cognitive impairment (mini mental state examination score less than 24 points); (3) history of stroke, traumatic brain injury or other neurological disease; (4) acute lower extremity or lower back pain, peripheral neuropathy, rheumatic- and orthopedic-related diseases; (5) unstable diseases and symptoms in the past six months, including cardiovascular disease and high blood pressure and/or diabetes; (6) those who cannot follow the exercise program or participate in other exercise programs at the same time.

All subjects who meet the inclusion conditions first fill in the general information assessment that includes basic personal characteristics, disease history, and related exercise habits. This is used to collect demographic data (depicted in Appendix 2) and fill in the Chinese version of the quality-of-life questionnaire, exercise behavior Conditioning Questionnaire, Pap Scale, Instrumental Activities of Daily Living Functioning Scale, and Mini-Mental State Test. The subject is said to have completed part of the test if they are unable to continue the remaining items due to physical and/or other factors. At this time, the subject will make an appointment to do the remaining items next time. All quizzes are expected to take approximately 40 minutes.

This study was a double-blind random assignment experiment, and the subjects and evaluators were unaware of the subjecs group. The subjects were randomly assigned to the intervention group (aerobic dance or aerobic exercise training in virtual reality), and they were asked to follow the virtual reality program to perform the requisite training. They could see whether their actions and those of other companions are correct.

The screen displays the percentage of correct movements. The time of each movement is five minutes with a 2-minute break in between for a total of 30 minutes, three times a week, for eight weeks, i.e., a total of 24 rounds. The heartbeat was monitored throughout. The control group did aerobic dance and exercise training without virtual reality. Exercise-related health education was also given, and changes in the physical functionality of the elderly living in the community were observed.

3.3.2 Intervention Aerobic dance: According to the demonstration video of the aerobic teacher, the initial training content combines basic movements with different purposes. The content is divided into 3METs, 4METs, 5METs, muscle strength training, and relaxation and stretching activity videos according to exercise intensity. Warm-up training must be done first followed by simple exercise intensity. After the task is over, a 5-minute rest is taken before entering higher-intensity task training, muscle strength training, and, finally, relaxation activities, for a total of 30 minutes.

Integrated movement training: For aerobic movement, basic activity introduction and basic movement explanation, as well as execution movement, will be analyzed by the software to find the exact ratio of movement, pulse rate, SpO2, and calories, in order to understand the basic movement training.

Circulation training: Cardiopulmonary function training uses different individuals\' exercise ability and cyclic tasks as the training design. The VR training content can record the individual\'s usage records and exercise intensity, and perform cyclic training for individual cases, adding repetitive exercises and stimulation.

All interventions will be delivered by trained therapists, three times a week for eight weeks, with each session lasting approximately 30 minutes. Before the intervention, all subjects were screened using the Physical Activity Readiness Questionnaire (PAR-Q), and static blood pressure was checked. Those whose blood pressure was higher than 160/90 mm Hg were advised to stop the experiment. After the intervention, the subjects\' breathing, heartbeat, and blood pressure were recorded to understand their physiological condition and gauge the action to be taken next. This could also involve performing primary and secondary assessment items such as physical fitness, Berg balance scale, standing time on one foot, activities of daily living,and quality of life before, immediately after, and one month after the intervention to verify the use of virtual reality aerobic dance effects of an aerobic exercise training intervention in the changes they cause in physical functionality of community-dwelling older adults.

Being tested
Kinect intervention system combined with aerobic exercise training, aerobic dance training
Keywords
Physical fitness, Community dwelling elderly, Virtual reality, Frailty
Medical subject headings
Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kinect intervention system combined with aerobic exercise trainingOther

    A Kinect intervention system was used in the experimental group. The video displayed a skeletal simulation of the action. The participants could see their own actions and those of the teacher. After the video was completed, an accurate score for each action was displayed.

  • aerobic dance trainingOther

    The control group used a video that did not show a skeletal simulation of the action and only saw the teachers movements.

Study groups in NCT06216236
Study groupRoleWhat they receive
Kinect intervention system combined with aerobic exercise trainingExperimentalKinect intervention system combined with aerobic exercise training
Receives: Other: Kinect intervention system combined with aerobic exercise training; Other: aerobic dance training
aerobic dance trainingNo interventionaerobic exercise at home.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The body mass index (BMI)

    Body mass index : The formula for calculating BMI is weight (kilograms, kg) divided by height squared (meters, m2)

    Measured: 30 min/session 3 sessions/week for 8 weeks.

  2. waist-to-hip ratio (WHR)

    2 Waist-to-hip ratio (WHR) Waist circumference is an important indicator to measure abdominal obesity. Waist-to-hip ratio is one of the important indicators of obesity in the elderly, and is also a predictor of simple cardiovascular diseases. Waist measurement is taken by standing with feet shoulder-width apart using a tape measure to measure the horizontal circumference parallel to the navel;

    Measured: 30 min/session 3 sessions/week for 8 weeks.

  3. chair stand test

    Measured: 30 min/session 3 sessions/week for 8 weeks.

  4. grip strength measurement

    Measured: 30 min/session 3 sessions/week for 8 weeks.

  5. 6-minute walk (6MWT) tests

    Measured: 30 min/session 3 sessions/week for 8 weeks.

Secondary outcomes (1)
  1. The Quality of Life Questionnaire by World Health Organization .

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2024
  2. Study start3 Feb 2024
  3. Primary completion3 Dec 2025
  4. Study completion3 Dec 2025

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06216236
Sponsor's protocol ID
VGHKS20-CT4-25
Status last verified
Dec 2025
First submitted
29 Dec 2023
Last updated
4 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Huang WY, Liou IH, Chang ST, Lee CH, Du YC, Cherng RJ. Effects of physical fitness using a Kinect system for pre-frail community-dwelling older adults. Front Public Health. 2025 Jun 11;13:1498606. doi: 10.3389/fpubh.2025.1498606. eCollection 2025.

    PubMed 40567995

Questions about this trial

What is this clinical trial studying?

A study testing Kinect intervention system combined with aerobic exercise training and aerobic dance training in people with Virtual Reality and Physical Fitness, run by Wan-Yun Huang at 2 sites 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 1 inclusion and 1 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 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The body mass index (BMI) (time frame: 30 min/session 3 sessions/week for 8 weeks.). The study lists 5 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 NCT06216236, 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 4 Dec 2025.

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