Attitude to Health, Dietary Modification, Health Behavior, Physical Activity, Vascular; Change
Conditions
Keywords
Heart Transplantation, Tonometry, Exercise Test, Diet, Cardiovascular Physiology, Telemedicine, Pediatrics, Health Behavior, Physical Fitness, Exercise Movement Techniques, Adolescent Behavior, Child Behavior
Brief summary
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.
Interventions
OTHEROn-Line Diet and Exercise Intervention
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.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 19 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Endothelial Pulse Amplitude Testing Index | Baseline, 16 weeks, and 32 weeks | Test of endothelial function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Carotid Artery Imaging | Baseline, 16 weeks, and 32 weeks | — |
| Fasting Low-Density Lipoprotein Level | Baseline, 16 weeks, and 32 weeks | — |
| Arterial Tonometry | Baseline, 16 weeks, and 32 weeks | — |
| Physical and Psychosocial Health Questionnaire Scores | Baseline, 16 weeks, and 32 weeks | Both parents and patients will be asked to complete this questionnaire |
| Functional Movement Screening Score | Baseline, 16 weeks, and 32 weeks | Participants will be asked to perform certain movements. The range of motion will be scored and totaled for evaluation. |
| Volume of Oxygen Consumed at Maximal Exertion | Baseline, 16 weeks, and 32 weeks | — |
Countries
United States
Outcome results
None listed