Virtual Reality Exercise in a Community Highschool for Children With Disabilities

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05935982
Collaborator
(none)
12
1
11.4

Study Details

Study Description

Brief Summary

The purpose of this study is to work with a community engagement group to develop and pilot a protocol for a virtual reality exergaming program for children with special needs at a high school.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Virtual reality exercise
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Preliminary Implementation and Development of an Enjoyable Virtual Reality Exercise Program for the Prevention of Cardiometabolic Disease Among Children With Disabilities in School Settings
Anticipated Study Start Date :
Aug 21, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Virtual reality exercise program in special physical education

During normal special physical education hours, participants will be provided with a virtual reality headset and exercise games and be prescribed to exercise at a moderate intensity.

Behavioral: Virtual reality exercise
During school special physical education, participants will be asked to exercise using a virtual reality exercise headset, that will be adapted for arm use. Participants will asked to be seated during gameplay. Heart rate will be monitored and recorded during exercise.

Outcome Measures

Primary Outcome Measures

  1. Enrollment rate [Start of project to end of enrollment period (quarter 3 of the year).]

    The percentage of people enrolling in the study versus those asked/screened.

  2. Attendance [Week 1 - Week 12]

    The percentage of minutes of exercise completed each week versus those prescribed.

  3. Retention of total exercise minutes [Week 13 - 24]

    Minutes of exercise completed per week throughout the retention period divided by the minutes achieved at week 12.

  4. Retention of moderate exercise minutes [Week 13 - 24]

    Minutes of exercise completed per week throughout the retention period divided by the minutes achieved at week 12.

  5. Moderate minutes [Week 1 - 12]

    The percentage of minutes of moderate obtained per week versus those prescribed.

Secondary Outcome Measures

  1. Weekly Minutes of Exercise Participation [Week 1 and Week 12]

    Participation in physical activities using a 7 day recall questionnaire, the Godin Leisure-Time Exercise Questionnaire.

  2. Physical activity enjoyment [Week 1 and Week 12]

    Physical Activity Enjoyment Scale (PACES). The scale ranges from 0 to 48. Scores above 24 are considered high enjoyment while being physically active.

  3. Walking or pushing endurance [Week 1 and Week 12]

    Distance covered throughout a 6 minute walk or push test.

  4. Hand grip strength [Week 1 an Week 12]

    Hand grip strength measured via a digital hand dynamometer

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 19 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Enrolled in school special physical education

  • Note from physician permitting participation in moderate intensity exercise

  • Ability to communicate in English (or a caregiver)

Exclusion Criteria:
  • Complete blindness or deafness

  • Condition that may make participation unsafe

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Alabama at Birmingham

Investigators

  • Principal Investigator: Byron Lai, PhD, University of Alabama at Birmingham

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Byron Lai, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT05935982
Other Study ID Numbers:
  • IRB-300011314
First Posted:
Jul 7, 2023
Last Update Posted:
Jul 10, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 10, 2023