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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21HD109358-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Wait-list Control | No Intervention | 12 weeks of maintaining habitual physical activity, diet, and nutrition patterns, until receiving 12 weeks of Movement-to-Music |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sprint-Intensity Interval Training with Telecoaching | Behavioral | Maximal intensity exercises that use the arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Weight | body weight in kg measured via DXA scan. Data represents the child participant. Outcome measures were not collected for the parent participant. | Week 0, Week 13 |
| Changes in Total Body Fat |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence to the Exercise Prescription | Percentage of sessions attended versus prescribed. Data represents the child participant. Outcome measures were not collected for the parent participant. | Week 1 - 12 |
| Number of Participants With Adverse Events |
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:
Exclusion Criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wellness Health And Research Facility (WHARF) | Homewood | Alabama | 35209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38441939 | Derived | 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. |
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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)
Beginning 3 months after publication and ending 5 years after publication.
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The enrollment number and number of participants started/completed represents the number of dyads. Each dyad includes one parent/caregiver and one child.
This study enrolled child-caregiver dyads.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Sprint-Intensity Interval Training with Telecoaching: Maximal intensity exercises that use the arms. |
| FG001 | Wait-list Control | 12 weeks of maintaining habitual physical activity, diet, and nutrition patterns, until receiving 12 weeks of Movement-to-Music |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Digital Consent |
| |||||||||||||
| Enrolled |
|
Baseline data was only collected for the child. Thus, baseline characteristics represent the child participant.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Sprint-Intensity Interval Training with Telecoaching: Maximal intensity exercises that use the arms. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Child participant |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | 95% Confidence Interval | mL/kg-1/min-1 | Week 0, Week 13 |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Sprint-Intensity Interval Training with Telecoaching: Maximal intensity exercises that use the arms. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Byron Lai | University of Alabama at Birmingham (UAB) | 205-638-9790 | 8-9725 | byronlai@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 7, 2025 | Feb 4, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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body fat in kg measured via DXA scan. Data represents the child participant. Outcome measures were not collected for the parent participant.
| Week 0, Week 13 |
| Changes in Total Lean Mass | lean mass in kg measured via DXA scan. Data represents the child participant. Outcome measures were not collected for the parent participant. | Week 0, Week 13 |
| Changes in Lean Tissue Percentage | percentage of lean tissue per whole body weight. Data represents the child participant. Outcome measures were not collected for the parent participant. | Week 0, Week 13 |
| Changes in Fat Tissue Percentage | percentage of fat tissue per whole body weight. Data represents the child participant. Outcome measures were not collected for the parent participant. | Week 0, Week 13 |
| Changes in C-reactive Protein | hsCRP (mg/L) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant. | Week 0, Week 13 |
| Changes in Hemoglobin A1C | HbA1C (mmol/mol) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant. | Week 0, Week 13 |
| Changes in Fasting Insulin | Fasting Insulin (μIU/mL) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant. | Week 0, Week 13 |
| Changes in Fasting Triglycerides | Fasting Triglycerides (mg/dL) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant. | Week 0, Week 13 |
| Changes in Fasting High-density Lipoprotein | HDL cholesterol (mg/dL) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant. | Week 0, Week 13 |
| Changes in Fasting Low-density Lipoprotein | LDL cholesterol (mg/dL) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant. | Week 0, Week 13 |
| Changes in Systolic Blood Pressure | systolic blood pressure (mmHg) measured via blood pressure cuff. Data represents the child participant. Outcome measures were not collected for the parent participant. | Week 0, Week 13 |
| Changes in Diastolic Blood Pressure | diastolic blood pressure (mmHg) measured via blood pressure cuff. Data represents the child participant. Outcome measures were not collected for the parent participant. | Week 0, Week 13 |
Any adverse event reported by participants (e.g., injury). Data represents the child participant. Outcome measures were not collected for the parent participant.
| Week 1 - 12 |
| NOT COMPLETED |
|
|
| BG001 |
| Wait-list Control |
12 weeks of maintaining habitual physical activity, diet, and nutrition patterns, until receiving 12 weeks of Movement-to-Music |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Child participant | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Child participant | Count of Participants | Participants |
|
| Race (NIH/OMB) | Child participant | Count of Participants | Participants |
|
| Gross Motor Function Classification Scale (GMFCS) | Child participant functional level. The GMFCS is a 5-level clinical classification system used to stage gross motor function in children and adolescents with cerebral palsy based on self-initiated movement, particularly sitting, walking, and mobility with or without assistive devices. Levels range from I (walks without limitations) to V (transported in a manual wheelchair), with increasing level indicating greater functional impairment. Lower GMFCS levels (I-II) represent better functional status, whereas higher levels (IV-V) indicate more severe motor limitations and worse outcomes. | Count of Participants | Participants |
|
12 weeks of maintaining habitual physical activity, diet, and nutrition patterns, until receiving 12 weeks of Movement-to-Music
|
|
| Secondary | Change in Body Weight | body weight in kg measured via DXA scan. Data represents the child participant. Outcome measures were not collected for the parent participant. | Posted | Mean | 95% Confidence Interval | Kg | Week 0, Week 13 |
|
|
|
| Secondary | Changes in Total Body Fat | body fat in kg measured via DXA scan. Data represents the child participant. Outcome measures were not collected for the parent participant. | Posted | Mean | 95% Confidence Interval | Kg | Week 0, Week 13 |
|
|
|
| Secondary | Changes in Total Lean Mass | lean mass in kg measured via DXA scan. Data represents the child participant. Outcome measures were not collected for the parent participant. | Posted | Mean | 95% Confidence Interval | Kg | Week 0, Week 13 |
|
|
|
| Secondary | Changes in Lean Tissue Percentage | percentage of lean tissue per whole body weight. Data represents the child participant. Outcome measures were not collected for the parent participant. | Posted | Mean | 95% Confidence Interval | percentage of lean mass | Week 0, Week 13 |
|
|
|
| Secondary | Changes in Fat Tissue Percentage | percentage of fat tissue per whole body weight. Data represents the child participant. Outcome measures were not collected for the parent participant. | Posted | Mean | 95% Confidence Interval | percentage of fat mass | Week 0, Week 13 |
|
|
|
| Secondary | Changes in C-reactive Protein | hsCRP (mg/L) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant. | Posted | Mean | 95% Confidence Interval | mg/L | Week 0, Week 13 |
|
|
|
| Secondary | Changes in Hemoglobin A1C | HbA1C (mmol/mol) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant. | Posted | Mean | 95% Confidence Interval | mmol/mol | Week 0, Week 13 |
|
|
|
| Secondary | Changes in Fasting Insulin | Fasting Insulin (μIU/mL) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant. | Posted | Mean | 95% Confidence Interval | μIU/mL | Week 0, Week 13 |
|
|
|
| Secondary | Changes in Fasting Triglycerides | Fasting Triglycerides (mg/dL) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant. | Posted | Mean | 95% Confidence Interval | mg/dL | Week 0, Week 13 |
|
|
|
| Secondary | Changes in Fasting High-density Lipoprotein | HDL cholesterol (mg/dL) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant. | Posted | Mean | 95% Confidence Interval | mg/dL | Week 0, Week 13 |
|
|
|
| Secondary | Changes in Fasting Low-density Lipoprotein | LDL cholesterol (mg/dL) measured via dried blood spot test. Data represents the child participant. Outcome measures were not collected for the parent participant. | Posted | Mean | 95% Confidence Interval | mg/dL | Week 0, Week 13 |
|
|
|
| Secondary | Changes in Systolic Blood Pressure | systolic blood pressure (mmHg) measured via blood pressure cuff. Data represents the child participant. Outcome measures were not collected for the parent participant. | Posted | Mean | Standard Deviation | mmHg | Week 0, Week 13 |
|
|
|
| Secondary | Changes in Diastolic Blood Pressure | diastolic blood pressure (mmHg) measured via blood pressure cuff. Data represents the child participant. Outcome measures were not collected for the parent participant. | Posted | Mean | Standard Deviation | mmHg | Week 0, Week 13 |
|
|
|
| Other Pre-specified | Adherence to the Exercise Prescription | Percentage of sessions attended versus prescribed. Data represents the child participant. Outcome measures were not collected for the parent participant. | Posted | Mean | Standard Deviation | percentage of sessions attended | Week 1 - 12 |
|
|
|
| Other Pre-specified | Number of Participants With Adverse Events | Any adverse event reported by participants (e.g., injury). Data represents the child participant. Outcome measures were not collected for the parent participant. | Posted | Count of Participants | Participants | Week 1 - 12 |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Wait-list Control | 12 weeks of maintaining habitual physical activity, diet, and nutrition patterns, until receiving 12 weeks of Movement-to-Music | 0 | 19 | 0 | 19 | 0 | 19 |
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