On-Line Intervention to Lower Cardiovascular Risk in Pediatric Heart Transplant Patients

Study Overview
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Brief Summary
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Pediatric heart transplant patients have a high-risk cardiovascular profile affecting their long-term outcomes and survival. Currently, no effective cardiovascular preventative care is provided for this pediatric population, in part, due to the fact that clinic-based programs are not easily accessible to children and their families. However, tele-health has been show to improve medical outcomes by making care more accessible to these patients. This study aims to meet the urgent need for an effective and sustainable delivery of preventative care to pediatric heart transplant patients using a diet and exercise intervention program delivered live over the internet direct to these patients' homes.

Conditions
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Vascular; Change, Dietary Modification, Physical Activity, Health Behavior, Attitude to Health

Intervention / Treatment
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* Other: On-Line Diet and Exercise Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Heart transplant >11 months before baseline visit Able to fast overnight Cardiac clearance to exercise by the primary cardiologist Presence of an adult at home during the exercise training sessions for patients < 14 years of age Exclusion Criteria: Acute illness Latex allergy Document transplant rejection < 3 months Re-transplantation or multi-organ transplantation Malignancy

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: On-Line Diet and Exercise Intervention<br> | Other: On-Line Diet and Exercise Intervention<br>* Initial 16 weeks of on-line, live exercise instruction 3x/week and on-line, diet sessions followed by 16 weeks of weekly exercise and diet sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Endothelial Pulse Amplitude Testing Index | Test of endothelial function | Baseline, 16 weeks, and 32 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial Tonometry |  | Baseline, 16 weeks, and 32 weeks | 
| Carotid Artery Imaging |  | Baseline, 16 weeks, and 32 weeks | 
| Fasting Low-Density Lipoprotein Level |  | Baseline, 16 weeks, and 32 weeks | 
| Volume of Oxygen Consumed at Maximal Exertion |  | Baseline, 16 weeks, and 32 weeks | 
| Physical and Psychosocial Health Questionnaire Scores | Both parents and patients will be asked to complete this questionnaire | Baseline, 16 weeks, and 32 weeks | 
| Functional Movement Screening Score | Participants will be asked to perform certain movements. The range of motion will be scored and totaled for evaluation. | Baseline, 16 weeks, and 32 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Transplantation, Tonometry, Exercise Test, Diet, Cardiovascular Physiology, Telemedicine, Pediatrics, Health Behavior, Physical Fitness, Exercise Movement Techniques, Adolescent Behavior, Child Behavior