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

NCT05619211 | Completed Phase 1 Results

• 2 other identifiers: IRB-3000103721R21HD109358-01A1
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Change in Body Weight

  Week 0, Week 13

• Changes in Total Body Fat

  Week 0, Week 13

• Changes in Total Lean Mass

  Week 0, Week 13

• Changes in Lean Tissue Percentage

  Week 0, Week 13

• Changes in Fat Tissue Percentage

  Week 0, Week 13

Other Outcomes (2)

• Adherence to the Exercise Prescription

  Week 1 - 12

• Number of Participants With Adverse Events

  Week 1 - 12

Study Arms (2)

Movement-to-Music

EXPERIMENTAL

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

Wait-list Control

NO INTERVENTION

12 weeks of maintaining habitual physical activity, diet, and nutrition patterns, until receiving 12 weeks of Movement-to-Music

Interventions

Sprint-Intensity Interval Training with Telecoaching BEHAVIORAL

Maximal intensity exercises that use the arms.

Movement-to-Music

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Wellness Health And Research Facility (WHARF)

Homewood, Alabama, 35209, United States

Location

Related Publications (1)

• 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.

  PMID: 38441939 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Byron Lai
• Organization: University of Alabama at Birmingham (UAB)

byronlai@uab.edu

205-638-9790

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 16, 2022
• Study Start: September 29, 2023
• Primary Completion: November 1, 2025
• Study Completion: December 18, 2025
• Last Updated: April 2, 2026
• Results First Posted: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 3 months after publication and ending 5 years after publication.

Locations

US (1)