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

NCT ID: NCT05619211

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-29

Study Completion Date

2025-12-08

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Sprint-Intensity Interval Training with Telecoaching

Intervention Type BEHAVIORAL

Maximal intensity exercises that use the arms.

Wait-list Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sprint-Intensity Interval Training with Telecoaching

Maximal intensity exercises that use the arms.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Byron Lai

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wellness Health And Research Facility (WHARF)

Homewood, Alabama, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38441939 (View on PubMed)

Other Identifiers

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1R21HD109358-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB-300010372

Identifier Type: -

Identifier Source: org_study_id