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Completed

NCT Number: NCT05619211

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

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.

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Key information

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Wellness Health And Research Facility (WHARF)

Homewood, Alabama, 35209, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sprint-Intensity Interval Training with Telecoaching

Behavioral

Maximal intensity exercises that use the arms.

Primary outcomes

  1. Changes in pVO2

    Time frame: Week 0, Week 13

    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.

Secondary outcomes

  1. Change in Body Weight

    Time frame: Week 0, Week 13

    body weight in kg measured via DXA scan. Data represents the child participant. Outcome measures were not collected for the parent participant.

  2. Changes in Total Body Fat

    Time frame: Week 0, Week 13

    body fat in kg measured via DXA scan. Data represents the child participant. Outcome measures were not collected for the parent participant.

  3. Changes in Total Lean Mass

    Time frame: Week 0, Week 13

    lean mass in kg measured via DXA scan. Data represents the child participant. Outcome measures were not collected for the parent participant.

  4. Changes in Lean Tissue Percentage

    Time frame: Week 0, Week 13

    percentage of lean tissue per whole body weight. Data represents the child participant. Outcome measures were not collected for the parent participant.

  5. Changes in Fat Tissue Percentage

    Time frame: Week 0, Week 13

    percentage of fat tissue per whole body weight. Data represents the child participant. Outcome measures were not collected for the parent participant.

  6. Changes in C-reactive Protein

    Time frame: Week 0, Week 13

    hsCRP (mg/L) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant.

  7. Changes in Hemoglobin A1C

    Time frame: Week 0, Week 13

    HbA1C (mmol/mol) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant.

  8. Changes in Fasting Insulin

    Time frame: Week 0, Week 13

    Fasting Insulin (μIU/mL) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant.

  9. Changes in Fasting Triglycerides

    Time frame: Week 0, Week 13

    Fasting Triglycerides (mg/dL) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant.

  10. Changes in Fasting High-density Lipoprotein

    Time frame: Week 0, Week 13

    HDL cholesterol (mg/dL) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant.

  11. Changes in Fasting Low-density Lipoprotein

    Time frame: Week 0, Week 13

    LDL cholesterol (mg/dL) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant.

  12. Changes in Systolic Blood Pressure

    Time frame: Week 0, Week 13

    systolic blood pressure (mmHg) measured via blood pressure cuff. Data represents the child participant. Outcome measures were not collected for the parent participant.

  13. Changes in Diastolic Blood Pressure

    Time frame: Week 0, Week 13

    diastolic blood pressure (mmHg) measured via blood pressure cuff. Data represents the child participant. Outcome measures were not collected for the parent participant.

Other outcomes

  1. Adherence to the Exercise Prescription

    Time frame: Week 1 - 12

    Percentage of sessions attended versus prescribed. Data represents the child participant. Outcome measures were not collected for the parent participant.

  2. Number of Participants With Adverse Events

    Time frame: Week 1 - 12

    Any adverse event reported by participants (e.g., injury). Data represents the child participant. Outcome measures were not collected for the parent participant.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 16, 2022
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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