Clinical trial NCT05619211: Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities
Official title: Improving Cardiorespiratory Fitness and Cardiometabolic Health Among Children With Physical Disabilities Through Movement-to-Music Telehealth With Arm-based Sprint-Intensity Interval Training
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Cerebral Palsy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-11-16
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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-III (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 IV-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.

Primary outcomes:
measure: Changes in pVO2
timeFrame: Week 0, Week 13
Secondary outcomes:
measure: change in body weight
timeFrame: Week 0, Week 13
measure: changes in total body fat
timeFrame: Week 0, Week 13
measure: changes in total lean mass
timeFrame: Week 0, Week 13
measure: changes in lean tissue percentage
timeFrame: Week 0, Week 13
measure: changes in fat tissue percentage
timeFrame: Week 0, Week 13
measure: changes in C-reactive protein
timeFrame: Week 0, Week 13
measure: changes in Hemoglobin A1C
timeFrame: Week 0, Week 13
measure: changes in fasting insulin
timeFrame: Week 0, Week 13
measure: changes in fasting triglycerides
timeFrame: Week 0, Week 13
measure: changes in fasting high-density lipoprotein
timeFrame: Week 0, Week 13
measure: changes in fasting low-density lipoprotein
timeFrame: Week 0, Week 13
measure: Changes in systolic blood pressure
timeFrame: Week 0, Week 13
measure: Changes in diastolic blood pressure
timeFrame: Week 0, Week 13
Other outcomes:
measure: Adherence to the exercise prescription
timeFrame: Week 1 - 12
measure: Perceived Enjoyment
timeFrame: Week 0, Week 13
measure: Recruitment, enrollment, and attrition rates
timeFrame: Week 1 - 12
measure: Adverse events
timeFrame: Week 1 - 12
Locations:
city: Homewood
country: United States
facility: Wellness Health And Research Facility (WHARF)
state: Alabama
Study officials:
References: