Resistive Action Video Games Enhance Functional Fitness of Disabled Workers in Sheltered Workshops

July 10, 2024 updated by: Jen-Suh Chern, National Taiwan Normal University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 106
        • National Taiwan Normal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • (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

Exclusion Criteria:

  • (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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
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.
Behavioral: Training program incorporating video aerobic exercise, action video game and resistive action video game
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.
No Intervention: Control group
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
One week before training, 6 weeks of training, 12 weeks of training.
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
One week before training, 6 weeks of training, 12 weeks of training.
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
One week before training, 6 weeks of training, 12 weeks of training.
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
One week before training, 6 weeks of training, 12 weeks of training.
Muscle strength
Time Frame: One week before training, after 6 weeks of training, after 12 weeks of training.
Bicep arm curl test
One week before training, after 6 weeks of training, after 12 weeks of training.
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.
One week before training, after 6 weeks of training, after 12 weeks of training.
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
One week before training, 6 weeks of training, 12 weeks of training.
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.
One week before training, 6 weeks of training, 12 weeks of training.
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.
One week before training, 6 weeks of training, 12 weeks of training.
Balance
Time Frame: One week before training, 6 weeks of training, 12 weeks of training.
Seconds to maintain one-leg stance stability
One week before training, 6 weeks of training, 12 weeks of training.
Agility
Time Frame: One week before training, 6 weeks of training, 12 weeks of training.
Timed-Up-and-Go test
One week before training, 6 weeks of training, 12 weeks of training.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan Normal University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jen-Suh Chern, PhD, National Taiwan Normal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NSTC 110-2410-H-003 -109 -MY2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share the individual participant data with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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