Phase 1
N=42
Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities
Cerebral Palsy
Bottom Line
View on ClinicalTrials.gov: NCT05619211 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Changes in pVO2 — 1.72; -0.61 mL/kg-1/min-1
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Sprint-Intensity Interval Training with Telecoaching (Behavioral)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Nov 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in pVO2 |
1.72; -0.61 | — |
| SECONDARY Change in Body Weight |
0.53; 1.38 | — |
| SECONDARY Changes in Total Body Fat |
0.03; 1.22 | — |
| SECONDARY Changes in Total Lean Mass |
0.47; 3.07 | — |
| SECONDARY Changes in Lean Tissue Percentage |
0.81; -0.21 | — |
| SECONDARY Changes in Fat Tissue Percentage |
-0.23; 1.72 | — |
| SECONDARY Changes in C-reactive Protein |
-0.29; 0.31 | — |
| SECONDARY Changes in Hemoglobin A1C |
0.10; 0.08 | — |
| SECONDARY Changes in Fasting Insulin |
-6.61; -0.95 | — |
| SECONDARY Changes in Fasting Triglycerides |
-12.93; 4.63 | — |
| SECONDARY Changes in Fasting High-density Lipoprotein |
-6.46; -2.63 | — |
| SECONDARY Changes in Fasting Low-density Lipoprotein |
-15.10; 0.94 | — |
| SECONDARY Changes in Systolic Blood Pressure |
0.87; 0.77 | — |
| SECONDARY Changes in Diastolic Blood Pressure |
-1.7; 2.8 | — |
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-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.
Data sourced from ClinicalTrials.gov (NCT05619211). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.