Virtual Reality Exercise in a Community Highschool for Children With Disabilities

Physical Inactivity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05935982
• Other study ID #: IRB-300011314
• Status: Recruiting
• Phase: Phase 1
• Start date: September 18, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: June 2024
• Source: University of Alabama at Birmingham
• Contact: Raven Young, BS
• Phone: 205.922.4137
• Email: ravensamuel[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: August 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Developmental Disabilities
• Developmental Disability
• Disability Physical
• Physical Inactivity

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital of Alabama	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment rate	The percentage of people enrolling in the study versus those asked/screened.	Start of project to end of enrollment period (quarter 3 of the year).
Primary	Attendance	The percentage of minutes of exercise completed each week versus those prescribed.	Week 1 - Week 12
Primary	Retention of total exercise minutes	Minutes of exercise completed per week throughout the retention period divided by the minutes achieved at week 12.	Week 13 - 24
Primary	Retention of moderate exercise minutes	Minutes of exercise completed per week throughout the retention period divided by the minutes achieved at week 12.	Week 13 - 24
Primary	Moderate minutes	The percentage of minutes of moderate obtained per week versus those prescribed.	Week 1 - 12
Secondary	Weekly Minutes of Exercise Participation	Participation in physical activities using a 7 day recall questionnaire, the Godin Leisure-Time Exercise Questionnaire.	Week 1 and Week 12
Secondary	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.	Week 1 and Week 12
Secondary	Walking or pushing endurance	Distance covered throughout a 6 minute walk or push test.	Week 1 and Week 12
Secondary	Hand grip strength	Hand grip strength measured via a digital hand dynamometer	Week 1 an Week 12