Cerebral Palsy
Conditions
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.
Interventions
BEHAVIORALSprint-Intensity Interval Training with Telecoaching
Maximal intensity exercises that use the arms.
Sponsors
University of Alabama at Birmingham
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 17 Years
Healthy volunteers
Yes
Inclusion 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-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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in pVO2 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | 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. |
| Changes in Total Body Fat | 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. |
| Changes in Total Lean Mass | 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. |
| Changes in Lean Tissue Percentage | 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. |
| Changes in Fat Tissue Percentage | 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. |
| Changes in C-reactive Protein | 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. |
| Changes in Hemoglobin A1C | 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. |
| Changes in Fasting Insulin | 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. |
| Changes in Fasting Triglycerides | 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. |
| Changes in Fasting High-density Lipoprotein | 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. |
| Changes in Fasting Low-density Lipoprotein | 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. |
| Changes in Systolic Blood Pressure | 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. |
| Changes in Diastolic Blood Pressure | 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. |
Countries
United States
Participant flow
Recruitment details
This study enrolled child-caregiver dyads.
Pre-assignment details
The enrollment number and number of participants started/completed represents the number of dyads. Each dyad includes one parent/caregiver and one child.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 12.3 years STANDARD_DEVIATION 3.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Gross Motor Function Classification Scale (GMFCS) I | 16 Participants |
| Gross Motor Function Classification Scale (GMFCS) II | 2 Participants |
| Gross Motor Function Classification Scale (GMFCS) III | 6 Participants |
| Gross Motor Function Classification Scale (GMFCS) IV | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 19 |
| other Total, other adverse events | 0 / 20 | 0 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 19 |
Outcome results
None listed