Improving Cardiorespiratory Fitness and Cardiometabolic Health Among Children With Physical Disabilities Through Movement-to-Music Telehealth With Arm-based Sprint-Intensity Interval Training

University of Alabama at Birmingham1 site in 1 country42 target enrollmentSeptember 29, 2023

ConditionsCerebral Palsy

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Cerebral Palsy
Sponsor: University of Alabama at Birmingham
Enrollment: 42
Locations: 1
Primary Endpoint: Changes in pVO2
Status: Completed
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is investigating the potential effects of a high-intensity home-exercise program among children with cerebral palsy. The program includes rhythmic movements to music that are adapted for wheelchair uses and age-appropriate themes. This project has the potential to address a large knowledge gap in the extant literature, because there are no widely accessible, evidence-based, enjoyable, and age-appropriate modalities for improving cardiovascular fitness or cardiometabolic health among children with disabilities who have mobility disabilities.

Registry

clinicaltrials.gov

Start Date

September 29, 2023

End Date

December 18, 2025

Last Updated

3 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Alabama at Birmingham

Responsible Party

Principal Investigator

Byron Lai

Assistant Professor

University of Alabama at Birmingham

Eligibility Criteria

Inclusion Criteria

•We are recruiting 50 parent-child dyads. Childs are the participant undergoing the exercise intervention. Parents are required to support the safety and schedule of the child participant. Parents are considered participants due to their responsibilities.
•Inclusion Criteria:
•have a medical diagnosis of cerebral palsy, as determined by ICD-10 codes
•aged 6-17 years old
•a Gross Motor Function Classification System Level I-IV (as determined via participant screening, explained in the protocol section below)
•medical clearance to participate in high-intensity exercise from a physician (using the attached medical screening form and explained in the intervention safety, monitoring, and response plan)
•access to a Wi-Fi Internet connection in the home via mobile phone or tablet computer
•a caregiver who will support and monitor the participant's safety during the intervention and manage the child's exercise schedule.

Exclusion Criteria

•physically active (defined as \>150 minutes per week of self-reported moderate-to-vigorous intensity exercise in a typical week)
•cannot use their arms for exercise
•a Gross Motor Function Classification Level of V
•complete blindness or deafness;
•Any past history of a contraindication to exercise testing according to American College of Sports Medicine (ACSM) guidelines (Liguori and American College of Sports Medicine, 2020): significant change in the resting electrocardiogram suggesting significant ischemia, myocardial infarction, or other cardiac event, unstable angina, uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise, symptomatic severe aortic stenosis, uncontrolled symptomatic heart failure, pulmonary embolus or pulmonary infarction, myocarditis or pericarditis, aneurysm.
•pregnant (due to radiation from a Dual Energy X-ray Absorptiometry \[DEXA\] scan)
•has not been seen by a physician within the last year
•uses a g-tube
•Eligible caregivers will include parents or legal guardians of the child, who can commit sufficient time to support the child in their roles for the study and communicate in English. Caregivers who have complete blindness or deafness will be excluded from participation.