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Virtual Reality Exercise in a Community Highschool for Children With Disabilities

Primary Purpose

Disability Physical, Developmental Disability, Physical Inactivity

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Virtual reality exercise
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Disability Physical

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Children's Hospital of AlabamaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Virtual reality exercise program in special physical education

Arm Description

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.

Outcomes

Primary Outcome Measures

Enrollment rate
The percentage of people enrolling in the study versus those asked/screened.
Attendance
The percentage of minutes of exercise completed each week versus those prescribed.
Retention of total exercise minutes
Minutes of exercise completed per week throughout the retention period divided by the minutes achieved at week 12.
Retention of moderate exercise minutes
Minutes of exercise completed per week throughout the retention period divided by the minutes achieved at week 12.
Moderate minutes
The percentage of minutes of moderate obtained per week versus those prescribed.

Secondary Outcome Measures

Weekly Minutes of Exercise Participation
Participation in physical activities using a 7 day recall questionnaire, the Godin Leisure-Time Exercise Questionnaire.
Physical activity enjoyment
Physical Activity Enjoyment Scale (PACES). The scale ranges from 0 to 48. Scores above 24 are considered high enjoyment while being physically active.
Walking or pushing endurance
Distance covered throughout a 6 minute walk or push test.
Hand grip strength
Hand grip strength measured via a digital hand dynamometer

Full Information

First Posted
June 29, 2023
Last Updated
September 18, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05935982
Brief Title
Virtual Reality Exercise in a Community Highschool for Children With Disabilities
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2023 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
Detailed Description
A virtual reality exercise program will be run during school special physical education hours at a public high school. The program will be implemented by a person with cerebral palsy. The exercise will include rhythmic movement to music and fitness games.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disability Physical, Developmental Disability, Physical Inactivity

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality exercise program in special physical education
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual reality exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Enrollment rate
Description
The percentage of people enrolling in the study versus those asked/screened.
Time Frame
Start of project to end of enrollment period (quarter 3 of the year).
Title
Attendance
Description
The percentage of minutes of exercise completed each week versus those prescribed.
Time Frame
Week 1 - Week 12
Title
Retention of total exercise minutes
Description
Minutes of exercise completed per week throughout the retention period divided by the minutes achieved at week 12.
Time Frame
Week 13 - 24
Title
Retention of moderate exercise minutes
Description
Minutes of exercise completed per week throughout the retention period divided by the minutes achieved at week 12.
Time Frame
Week 13 - 24
Title
Moderate minutes
Description
The percentage of minutes of moderate obtained per week versus those prescribed.
Time Frame
Week 1 - 12
Secondary Outcome Measure Information:
Title
Weekly Minutes of Exercise Participation
Description
Participation in physical activities using a 7 day recall questionnaire, the Godin Leisure-Time Exercise Questionnaire.
Time Frame
Week 1 and Week 12
Title
Physical activity enjoyment
Description
Physical Activity Enjoyment Scale (PACES). The scale ranges from 0 to 48. Scores above 24 are considered high enjoyment while being physically active.
Time Frame
Week 1 and Week 12
Title
Walking or pushing endurance
Description
Distance covered throughout a 6 minute walk or push test.
Time Frame
Week 1 and Week 12
Title
Hand grip strength
Description
Hand grip strength measured via a digital hand dynamometer
Time Frame
Week 1 an Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raven Young, BS
Phone
205.922.4137
Email
ravensamuel@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byron Lai, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byron Lai, PhD
Phone
205-200-1724
Email
byronlai@uab.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Virtual Reality Exercise in a Community Highschool for Children With Disabilities

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