NCT06504355

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 16, 2024

Completed
Last Updated

July 16, 2024

Status Verified

July 1, 2024

Enrollment Period

2.4 years

First QC Date

June 27, 2024

Last Update Submit

July 10, 2024

Conditions

Keywords

Disabled workersSheltered workshopsFunctional fitnessPhysical activitiesResistive video gamesAction video games

Outcome Measures

Primary Outcomes (11)

  • Body weight

    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

    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

    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

    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

    Bicep arm curl test

    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.

    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

    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.

    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.

    One week before training, 6 weeks of training, 12 weeks of training.

  • Balance

    Seconds to maintain one-leg stance stability

    One week before training, 6 weeks of training, 12 weeks of training.

  • Agility

    Timed-Up-and-Go test

    One week before training, 6 weeks of training, 12 weeks of training.

Study Arms (2)

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.

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.

Interventions

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.

Experimental group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Normal University

Taipei, 106, Taiwan

Location

MeSH Terms

Conditions

Mental DisordersMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jen-Suh Chern, PhD

    National Taiwan Normal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 27, 2024

First Posted

July 16, 2024

Study Start

August 1, 2021

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

July 16, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

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

Locations