Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Behavioral: Sprint-Intensity Interval Training with Telecoaching

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Homewood, Alabama, United States, 35209
      • Wellness Health and Research Facility (WHARF)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Movement-to-Music; 12 weeks of sprint-intensity interval training while following along with YouTube videos that include arm-based routines, with coaching through telecommunications. Participants are instructed to maintain their habitual diet and nutrition patterns	Behavioral: Sprint-Intensity Interval Training with Telecoaching; Maximal intensity exercises that use the arms.
No Intervention: Wait-list Control; 12 weeks of maintaining habitual physical activity, diet, and nutrition patterns, until receiving 12 weeks of Movement-to-Music

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in pVO2	peak oxygen consumption (mL/kg-1/min-1) obtained from a graded exercise test on an arm ergometer. Data represents the child participant. Outcome measures were not collected for the parent participant.	Week 0, Week 13

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Weight	body weight in kg measured via DXA scan. Data represents the child participant. Outcome measures were not collected for the parent participant.	Week 0, Week 13
Changes in Total Body Fat	body fat in kg measured via DXA scan. Data represents the child participant. Outcome measures were not collected for the parent participant.	Week 0, Week 13
Changes in Total Lean Mass	lean mass in kg measured via DXA scan. Data represents the child participant. Outcome measures were not collected for the parent participant.	Week 0, Week 13
Changes in Lean Tissue Percentage	percentage of lean tissue per whole body weight. Data represents the child participant. Outcome measures were not collected for the parent participant.	Week 0, Week 13
Changes in Fat Tissue Percentage	percentage of fat tissue per whole body weight. Data represents the child participant. Outcome measures were not collected for the parent participant.	Week 0, Week 13
Changes in C-reactive Protein	hsCRP (mg/L) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant.	Week 0, Week 13
Changes in Hemoglobin A1C	HbA1C (mmol/mol) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant.	Week 0, Week 13
Changes in Fasting Insulin	Fasting Insulin (μIU/mL) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant.	Week 0, Week 13
Changes in Fasting Triglycerides	Fasting Triglycerides (mg/dL) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant.	Week 0, Week 13
Changes in Fasting High-density Lipoprotein	HDL cholesterol (mg/dL) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant.	Week 0, Week 13
Changes in Fasting Low-density Lipoprotein	LDL cholesterol (mg/dL) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant.	Week 0, Week 13
Changes in Systolic Blood Pressure	systolic blood pressure (mmHg) measured via blood pressure cuff. Data represents the child participant. Outcome measures were not collected for the parent participant.	Week 0, Week 13
Changes in Diastolic Blood Pressure	diastolic blood pressure (mmHg) measured via blood pressure cuff. Data represents the child participant. Outcome measures were not collected for the parent participant.	Week 0, Week 13

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to the Exercise Prescription	Percentage of sessions attended versus prescribed. Data represents the child participant. Outcome measures were not collected for the parent participant.	Week 1 - 12
Number of Participants With Adverse Events	Any adverse event reported by participants (e.g., injury). Data represents the child participant. Outcome measures were not collected for the parent participant.	Week 1 - 12

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

General Publications

• Lai B, Oster RA, Davis D, Bright L, Fisher G, Wilroy J, Kim Y, Young R, Wright A, Sinha T, Rimmer JH. Telehealth Movement-to-Music With Arm-Based Sprint-Intensity Interval Training to Improve Cardiometabolic Health and Cardiorespiratory Fitness in Children With Cerebral Palsy: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Mar 5;13:e56499. doi: 10.2196/56499.

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2023
• Primary Completion (Actual): November 1, 2025
• Study Completion (Actual): December 18, 2025

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 16, 2022

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: IRB-300010372; 1R21HD109358-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be submitted into the NICHD Data and Specimen Hub (DASH). Intellectual property and data generated under this project will be administered in accordance with both University and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance under notice NOT-OD-03-032 (released February 26, 2003)
• IPD Sharing Time Frame: Beginning 3 months after publication and ending 5 years after publication.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No