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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05619211
• Other study ID #: 1R21HD109358-01A1
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: September 29, 2023
• Est. completion date: March 31, 2025

Study information

• Verified date: November 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: March 31, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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-III (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 IV-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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Behavioral:
• Sprint-Intensity Interval Training with Telecoaching
Maximal intensity exercises that use the arms.

Locations

Country	Name	City	State
United States	Wellness Health And Research Facility (WHARF)	Homewood	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence to the exercise prescription	Percentage of video minutes completed versus prescribed	Week 1 - 12
Other	Perceived Enjoyment	Physical Activity Enjoyment Scale (PACES). The scale ranges from 0 to 48. Scores above 24 are considered high enjoyment while being physically active.	Week 0, Week 13
Other	Recruitment, enrollment, and attrition rates	Percentage of those who do the above, divided by the total participants	Week 1 - 12
Other	Adverse events	Any adverse event reported by participants	Week 1 - 12
Primary	Changes in pVO2	peak oxygen consumption (mL/kg-1/min-1) obtained from a graded exercise test on an arm ergometer	Week 0, Week 13
Secondary	change in body weight	body weight in pounds (lbs) measured via DXA scan	Week 0, Week 13
Secondary	changes in total body fat	body fat in pounds (lbs) measured via DXA scan	Week 0, Week 13
Secondary	changes in total lean mass	lean mass in pounds (lbs) measured via DXA scan	Week 0, Week 13
Secondary	changes in lean tissue percentage	percentage of lean tissue per whole body weight	Week 0, Week 13
Secondary	changes in fat tissue percentage	percentage of fat tissue per whole body weight	Week 0, Week 13
Secondary	changes in C-reactive protein	hsCRP (mg/L) measured via dried blood spot test	Week 0, Week 13
Secondary	changes in Hemoglobin A1C	HbA1C (mmol/mol) measured via dried blood spot test	Week 0, Week 13
Secondary	changes in fasting insulin	Fasting Insulin (µIU/mL) measured via dried blood spot test	Week 0, Week 13
Secondary	changes in fasting triglycerides	Fasting Triglycerides (mg/dL) measured via dried blood spot test	Week 0, Week 13
Secondary	changes in fasting high-density lipoprotein	HDL cholesterol (mg/dL) measured via dried blood spot test	Week 0, Week 13
Secondary	changes in fasting low-density lipoprotein	LDL cholesterol (mg/dL) measured via dried blood spot test	Week 0, Week 13
Secondary	Changes in systolic blood pressure	systolic blood pressure (mmHg) measured via blood pressure cuff	Week 0, Week 13
Secondary	Changes in diastolic blood pressure	diastolic blood pressure (mmHg) measured via blood pressure cuff	Week 0, Week 13