Abstract
Background
Children with mobility disabilities, including those with cerebral palsy, have limited options and limited time to exercise to manage their cardiometabolic health and cardiorespiratory fitness. Regular cardiovascular exercise during childhood is a critical health behavior for preventing health decline in adulthood. Thus, there is an urgent need for accessible, age-appropriate, convenient exercise modalities in this group. Sprint-intensity interval training (SIT), combined with telehealth procedures, may be ideal for children with disabilities. SIT includes repetitive bouts of maximal exercise effort combined with rest periods, which can be effective in eliciting comparable results to moderate-exercise training with very short training durations.
Objective
This phase 1 pilot feasibility randomized controlled trial aims to investigate the potential effects of a 12-week SIT program on indicators of cardiorespiratory fitness and cardiometabolic health among children with cerebral palsy. An ancillary aim is to evaluate the feasibility of the program through several process feasibility metrics.
Methods
This study uses a 2-armed parallel group design. A total of 50 physically inactive children with cerebral palsy (aged 6-17 years) will be randomly allocated into 1 of 2 groups: a 12-week SIT or a waitlist control group that continues habitual activity for 12 weeks. The SIT prescription includes 3 tele-supervised sessions per week with 30 repeated sequences of 4 seconds of maximal arm exercise, with active recovery, warm-up, and cooldown periods (for an approximately 20-minute total session). SIT includes guided videos with child-themed arm routines and music. The exercise sessions will be remotely supervised through a web-based videoconference application and include safety monitoring equipment. Outcomes are measured at pre- and postintervention (weeks 0 and 13, respectively). Health outcome measures include peak oxygen consumption (VO2 peak), measured by a graded exercise test; high-sensitivity C-reactive protein and blood insulin, hemoglobin A1c, triglycerides, and cholesterol using a finger stick dried blood spot test; blood pressure, using a sphygmomanometer; and body composition (total mass, total lean mass, tissue % lean, and tissue % fat) using dual x-ray absorptiometry. Feasibility will be evaluated by the following metrics: adverse events or problems experienced throughout the intervention related to participant safety; perceived enjoyment; and recruitment, enrollment, and attrition rates.
Results
Recruitment procedures started in November 2023. All data are anticipated to be collected by February 2025. Full trial results are anticipated to be analyzed and submitted for publication by March 2025. Secondary analyses of data will be subsequently published.
Conclusions
This trial tests an accessible and low-cost exercise program that leverages principles of high-intensity exercise to provide a convenient program for children with physical disabilities. Knowledge obtained from this study will inform the development of a larger trial for improving the cardiometabolic health, cardiorespiratory fitness, and well-being of children with physical disabilities.
Trial Registration
ClinicalTrials.gov NCT05619211; https://clinicaltrials.gov/study/NCT05619211
International Registered Report Identifier (IRRID)
DERR1-10.2196/56499