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

Primary Purpose

Cerebral Palsy

Status
Enrolling by invitation
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sprint-Intensity Interval Training with Telecoaching
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

6 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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, suspected or known dissecting aneurysm, systematic infection, accompanied by fever, body aches, or swollen lymph glands. 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.

Sites / Locations

  • Wellness Health And Research Facility (WHARF)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Movement-to-Music

Wait-list Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in pVO2
peak oxygen consumption (mL/kg-1/min-1) obtained from a graded exercise test on an arm ergometer

Secondary Outcome Measures

change in body weight
body weight in pounds (lbs) measured via DXA scan
changes in total body fat
body fat in pounds (lbs) measured via DXA scan
changes in total lean mass
lean mass in pounds (lbs) measured via DXA scan
changes in lean tissue percentage
percentage of lean tissue per whole body weight
changes in fat tissue percentage
percentage of fat tissue per whole body weight
changes in C-reactive protein
hsCRP (mg/L) measured via dried blood spot test
changes in Hemoglobin A1C
HbA1C (mmol/mol) measured via dried blood spot test
changes in fasting insulin
Fasting Insulin (μIU/mL) measured via dried blood spot test
changes in fasting triglycerides
Fasting Triglycerides (mg/dL) measured via dried blood spot test
changes in fasting high-density lipoprotein
HDL cholesterol (mg/dL) measured via dried blood spot test
changes in fasting low-density lipoprotein
LDL cholesterol (mg/dL) measured via dried blood spot test
Changes in systolic blood pressure
systolic blood pressure (mmHg) measured via blood pressure cuff
Changes in diastolic blood pressure
diastolic blood pressure (mmHg) measured via blood pressure cuff

Full Information

First Posted
November 2, 2022
Last Updated
September 29, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05619211
Brief Title
Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 29, 2023 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Movement-to-Music
Arm Type
Experimental
Arm Description
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
Arm Title
Wait-list Control
Arm Type
No Intervention
Arm Description
12 weeks of maintaining habitual physical activity, diet, and nutrition patterns, until receiving 12 weeks of Movement-to-Music
Intervention Type
Behavioral
Intervention Name(s)
Sprint-Intensity Interval Training with Telecoaching
Intervention Description
Maximal intensity exercises that use the arms.
Primary Outcome Measure Information:
Title
Changes in pVO2
Description
peak oxygen consumption (mL/kg-1/min-1) obtained from a graded exercise test on an arm ergometer
Time Frame
Week 0, Week 13
Secondary Outcome Measure Information:
Title
change in body weight
Description
body weight in pounds (lbs) measured via DXA scan
Time Frame
Week 0, Week 13
Title
changes in total body fat
Description
body fat in pounds (lbs) measured via DXA scan
Time Frame
Week 0, Week 13
Title
changes in total lean mass
Description
lean mass in pounds (lbs) measured via DXA scan
Time Frame
Week 0, Week 13
Title
changes in lean tissue percentage
Description
percentage of lean tissue per whole body weight
Time Frame
Week 0, Week 13
Title
changes in fat tissue percentage
Description
percentage of fat tissue per whole body weight
Time Frame
Week 0, Week 13
Title
changes in C-reactive protein
Description
hsCRP (mg/L) measured via dried blood spot test
Time Frame
Week 0, Week 13
Title
changes in Hemoglobin A1C
Description
HbA1C (mmol/mol) measured via dried blood spot test
Time Frame
Week 0, Week 13
Title
changes in fasting insulin
Description
Fasting Insulin (μIU/mL) measured via dried blood spot test
Time Frame
Week 0, Week 13
Title
changes in fasting triglycerides
Description
Fasting Triglycerides (mg/dL) measured via dried blood spot test
Time Frame
Week 0, Week 13
Title
changes in fasting high-density lipoprotein
Description
HDL cholesterol (mg/dL) measured via dried blood spot test
Time Frame
Week 0, Week 13
Title
changes in fasting low-density lipoprotein
Description
LDL cholesterol (mg/dL) measured via dried blood spot test
Time Frame
Week 0, Week 13
Title
Changes in systolic blood pressure
Description
systolic blood pressure (mmHg) measured via blood pressure cuff
Time Frame
Week 0, Week 13
Title
Changes in diastolic blood pressure
Description
diastolic blood pressure (mmHg) measured via blood pressure cuff
Time Frame
Week 0, Week 13
Other Pre-specified Outcome Measures:
Title
Adherence to the exercise prescription
Description
Percentage of video minutes completed versus prescribed
Time Frame
Week 1 - 12
Title
Perceived Enjoyment
Description
Physical Activity Enjoyment Scale (PACES). The scale ranges from 0 to 48. Scores above 24 are considered high enjoyment while being physically active.
Time Frame
Week 0, Week 13
Title
Recruitment, enrollment, and attrition rates
Description
Percentage of those who do the above, divided by the total participants
Time Frame
Week 1 - 12
Title
Adverse events
Description
Any adverse event reported by participants
Time Frame
Week 1 - 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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, suspected or known dissecting aneurysm, systematic infection, accompanied by fever, body aches, or swollen lymph glands. 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.
Facility Information:
Facility Name
Wellness Health And Research Facility (WHARF)
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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

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