Mental DisorderNCT06504355
Resistive Action Video Games Enhance Functional Fitness of Disabled Workers in Sheltered Workshops
A study testing Training program incorporating video aerobic exercise, action video game and resistive action video game in people with Mental Disorder, run by National Taiwan Normal University at 1 site in Taiwan.
Trial summary
Aims: Investigating the efficacy of resistive action video games on functional fitness (FF) of disabled workers in sheltered workshops (DWSWs). Methods: Thirty-two DWSWs participated in this study and were allocated as either experimental group (EG) or control group (CG). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Mental Disorder
- What is being tested?
- Training program incorporating video aerobic exercise, action video game and resistive action video game
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2021to 31 Dec 2023
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) aged more than 20 years; (2) diagnosis of an intellectual disability, autism, or a psychiatric disorder; (3) employed for at least 6 hours per day and five days a week in the sheltered workshop; (4) capable of following verbal instructions to enable outcome measurement and of participating in the training program; and (5) voluntary agreement to participate and signed the informed consent form
Who cannot join
- (1) advisement against performing moderate- to high-intensity physical activities by a physician and (2) physical limitations preventing independent walking or standing without an assistive device.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Functional Fitness of Disabled Workers in Sheltered Workshops Through a Training Program Incorporating Resistive Action Video Games
Aims: Investigating the efficacy of resistive action video games on functional fitness (FF) of disabled workers in sheltered workshops (DWSWs).
Methods: Thirty-two DWSWs participated in this study and were allocated as either experimental group (EG) or control group (CG). DWSWs in EG underwent three 60-minute sessions each week for 12 weeks; those in CG maintained daily routine. The outcomes included all components FF and were measures at pre-, mid- and post-training.
Read the detailed description
Purpose: To investigate the efficacy of a training program including resistive action video games on functional fitness (FF) of disabled workers in sheltered workshops (DWSWs).
Material and methods: Thirty-two DWSWs participated in this study and were allocated as either experimental group (EG) or control group (CG). DWSWs in EG underwent three 60-minute training sessions each week for 12 weeks. One of the session is group training and two of the sessions are individual session. In group session, the participants do aerobic exercise following a video which was launch by the health management ministry of city government. In the individual session, the participants play play two video games alternatively. The video games used are Fitness Boxing 2 and Adventure Ring-Fit. In addition to the training program, the participants in the EG maintain work and leisure routine in addition to the added training. The participants in the CG maintained daily work and leisure routine.The outcome measures included body mass index, body weight, body fat percentage, skeletal muscle rate, muscle strength, cardiopulmonary endurance, flexibility, balance and agility. All participants must be evaluated of the outcome measures at pre-, mid- and post-training time point.
- Conditions
- Mental Disorder
- Being tested
- Training program incorporating video aerobic exercise, action video game and resistive action video game
- Keywords
- Disabled workers, Sheltered workshops, Functional fitness, Physical activities, Resistive video games, Action video games
- Medical subject headings
- Mental Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training program incorporating video aerobic exercise, action video game and resistive action video gameBehavioural
Participants in the experimental group participated in three 60-minute training sessions each week for 12 weeks. One of the session was group training. The other two session were individual training. In the group training session, the participants participate in the video aerobic exercise; in the individual sessions, the participants play action and resistive action video games: Fitness Boxing 2 and Adventure Ring-Fit. All participants in the experimental group wore a hear rate monitoring watch so that the researchers make sure that medium level of physical activities was achieved in each session.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants in the experimental group participated in three 60-minute training sessions each week for 12 weeks. One of the session was group training. The other two session were individual training. In the group training session, the participants participate in the video aerobic exercise; in the individual sessions, the participants play action and resistive action video games: Fitness Boxing 2 and Adventure Ring-Fit. All participants in the experimental group wore a hear rate monitoring watch so that the researchers make sure that medium level of physical activities was achieved in each session. The participants underwent pre-, mid- and post-training measures of the outcome parameters which includes body weight, body mass index, basal metabolic rate, skeletal muscle rate, body fat percentage, flexibility, balance and agility. Receives: Behavioral: Training program incorporating video aerobic exercise, action video game and resistive action video game |
| Control group | No intervention | The participants in the control group underwent no any special training but maintain daily work and leisure routines. They underwent pre-, mid- and post-experimental measures of the outcome parameters which was the same as those measured in the experimental group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
On the counter Omron four-point bluetooth transmission weight and body fat meter HBF 702T was used
Measured: One week before training, 6 weeks of training, 12 weeks of training.
Body mass index
On the counter Omron four-point bluetooth transmission weight and body fat meter HBF 702T was used
Measured: One week before training, 6 weeks of training, 12 weeks of training.
Body fat percentage
On the counter Omron four-point bluetooth transmission weight and body fat meter HBF 702T was used
Measured: One week before training, 6 weeks of training, 12 weeks of training.
Skeletal muscle rate
On the counter Omron four-point bluetooth transmission weight and body fat meter HBF 702T was used
Measured: One week before training, 6 weeks of training, 12 weeks of training.
Muscle strength
Bicep arm curl test
Measured: One week before training, after 6 weeks of training, after 12 weeks of training.
Muscle strength
Counts of strand-up in the 30-second chair stand test.
Measured: One week before training, after 6 weeks of training, after 12 weeks of training.
Cardiopulmonary endurance
Counts of steps in the 2-minute step test
Measured: One week before training, 6 weeks of training, 12 weeks of training.
Flexibility
The distance in centimeters between two middle fingers in the Back scratch test.
Measured: One week before training, 6 weeks of training, 12 weeks of training.
Flexibility
The distance in centimeters between the middle fingers and the big toe in sit and reach test.
Measured: One week before training, 6 weeks of training, 12 weeks of training.
Balance
Seconds to maintain one-leg stance stability
Measured: One week before training, 6 weeks of training, 12 weeks of training.
Agility
Timed-Up-and-Go test
Measured: One week before training, 6 weeks of training, 12 weeks of training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start1 Aug 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisorderStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jen-Suh Chern, National Taiwan Normal University
- Investigators
- Jen-Suh Chern, PhD, Principal investigator, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504355
- Sponsor's protocol ID
- NSTC 110-2410-H-003 -109 -MY2
- Status last verified
- Jul 2024
- First submitted
- 27 Jun 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share the individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Functional Fitness of Disabled Workers in Sheltered Workshops Through a Training Program Incorporating Resistive Action Video Games
- ClinicalTrials.gov ID
- NCT06504355
- Acronym / sponsor ID
- NSTC 110-2410-H-003 -109 -MY2
- Conditions
- Mental Disorder
- Keywords
- Disabled workers, Sheltered workshops, Functional fitness, Physical activities, Resistive video games, Action video games
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 16 Jul 2024 (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.
Aims: Investigating the efficacy of resistive action video games on functional fitness (FF) of disabled workers in sheltered workshops (DWSWs).
Methods: Thirty-two DWSWs participated in this study and were allocated as either experimental group (EG) or control group (CG). DWSWs in EG underwent three 60-minute sessions each week for 12 weeks; those in CG maintained daily routine. The outcomes included all components FF and were measures at pre-, mid- and post-training.
Detailed description
Purpose: To investigate the efficacy of a training program including resistive action video games on functional fitness (FF) of disabled workers in sheltered workshops (DWSWs).
Material and methods: Thirty-two DWSWs participated in this study and were allocated as either experimental group (EG) or control group (CG). DWSWs in EG underwent three 60-minute training sessions each week for 12 weeks. One of the session is group training and two of the sessions are individual session. In group session, the participants do aerobic exercise following a video which was launch by the health management ministry of city government. In the individual session, the participants play play two video games alternatively. The video games used are Fitness Boxing 2 and Adventure Ring-Fit. In addition to the training program, the participants in the EG maintain work and leisure routine in addition to the added training. The participants in the CG maintained daily work and leisure routine.The outcome measures included body mass index, body weight, body fat percentage, skeletal muscle rate, muscle strength, cardiopulmonary endurance, flexibility, balance and agility. All participants must be evaluated of the outcome measures at pre-, mid- and post-training time point.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Training program incorporating video aerobic exercise, action video game and resistive action video gameParticipants in the experimental group participated in three 60-minute training sessions each week for 12 weeks. One of the session was group training. The other two session were individual training. In the group training session, the participants participate in the video aerobic exercise; in the individual sessions, the participants play action and resistive action video games: Fitness Boxing 2 and Adventure Ring-Fit. All participants in the experimental group wore a hear rate monitoring watch so that the researchers make sure that medium level of physical activities was achieved in each session. The participants underwent pre-, mid- and post-training measures of the outcome parameters which includes body weight, body mass index, basal metabolic rate, skeletal muscle rate, body fat percentage, flexibility, balance and agility. |
| Control group | No intervention | –The participants in the control group underwent no any special training but maintain daily work and leisure routines. They underwent pre-, mid- and post-experimental measures of the outcome parameters which was the same as those measured in the experimental group. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) aged more than 20 years; (2) diagnosis of an intellectual disability, autism, or a psychiatric disorder; (3) employed for at least 6 hours per day and five days a week in the sheltered workshop; (4) capable of following verbal instructions to enable outcome measurement and of participating in the training program; and (5) voluntary agreement to participate and signed the informed consent form
Key exclusion criteria (1 listed)
- (1) advisement against performing moderate- to high-intensity physical activities by a physician and (2) physical limitations preventing independent walking or standing without an assistive device.
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 |
|---|---|---|
| Training program incorporating video aerobic exercise, action video game and resistive action video gameParticipants in the experimental group participated in three 60-minute training sessions each week for 12 weeks. One of the session was group training. The other two session were individual training. In the group training session, the participants participate in the video aerobic exercise; in the individual sessions, the participants play action and resistive action video games: Fitness Boxing 2 and Adventure Ring-Fit. All participants in the experimental group wore a hear rate monitoring watch so that the researchers make sure that medium level of physical activities was achieved in each session. | Behavioural | Experimental group |
Primary outcome
Body weight
Time frame: One week before training, 6 weeks of training, 12 weeks of training.
On the counter Omron four-point bluetooth transmission weight and body fat meter HBF 702T was used
Body mass index
Time frame: One week before training, 6 weeks of training, 12 weeks of training.
On the counter Omron four-point bluetooth transmission weight and body fat meter HBF 702T was used
Body fat percentage
Time frame: One week before training, 6 weeks of training, 12 weeks of training.
On the counter Omron four-point bluetooth transmission weight and body fat meter HBF 702T was used
Skeletal muscle rate
Time frame: One week before training, 6 weeks of training, 12 weeks of training.
On the counter Omron four-point bluetooth transmission weight and body fat meter HBF 702T was used
Muscle strength
Time frame: One week before training, after 6 weeks of training, after 12 weeks of training.
Bicep arm curl test
Muscle strength
Time frame: One week before training, after 6 weeks of training, after 12 weeks of training.
Counts of strand-up in the 30-second chair stand test.
Cardiopulmonary endurance
Time frame: One week before training, 6 weeks of training, 12 weeks of training.
Counts of steps in the 2-minute step test
Flexibility
Time frame: One week before training, 6 weeks of training, 12 weeks of training.
The distance in centimeters between two middle fingers in the Back scratch test.
Flexibility
Time frame: One week before training, 6 weeks of training, 12 weeks of training.
The distance in centimeters between the middle fingers and the big toe in sit and reach test.
Balance
Time frame: One week before training, 6 weeks of training, 12 weeks of training.
Seconds to maintain one-leg stance stability
Agility
Time frame: One week before training, 6 weeks of training, 12 weeks of training.
Timed-Up-and-Go 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 16 Jul 2024.
- Individual participant dataSharing planned: No. There is no plan to share the individual participant data with other researchers.
Related trials for Mental Disorder
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Recruiting
Safety and Performance of UCon Patch Electrode
Urinary Incontinence, Urinary Incontinence, Urge
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.
Jen-Suh Chern, PhD principal investigator
National Taiwan Normal 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 Training program incorporating video aerobic exercise, action video game and resistive action video game in people with Mental Disorder, 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 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 16 Jul 2024. 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?
Body weight (time frame: One week before training, 6 weeks of training, 12 weeks of training.). The study lists 11 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 16 Jul 2024; AzTrials last refreshed its copy on 8 Nov 2026.