Clinical trial NCT02519946: On-Line Intervention to Lower Cardiovascular Risk in Pediatric Heart Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular; Change
Dietary Modification
Physical Activity
Health Behavior
Attitude to Health
Keywords: Heart Transplantation
Tonometry
Exercise Test
Diet
Cardiovascular Physiology
Telemedicine
Pediatrics
Health Behavior
Physical Fitness
Exercise Movement Techniques
Adolescent Behavior
Child Behavior
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2015-08-11
Enrollment: 14
Sex: ALL
Minimum age (years): 9
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Endothelial Pulse Amplitude Testing Index
timeFrame: Baseline, 16 weeks, and 32 weeks
Secondary outcomes:
measure: Arterial Tonometry
timeFrame: Baseline, 16 weeks, and 32 weeks
measure: Carotid Artery Imaging
timeFrame: Baseline, 16 weeks, and 32 weeks
measure: Fasting Low-Density Lipoprotein Level
timeFrame: Baseline, 16 weeks, and 32 weeks
measure: Volume of Oxygen Consumed at Maximal Exertion
timeFrame: Baseline, 16 weeks, and 32 weeks
measure: Physical and Psychosocial Health Questionnaire Scores
timeFrame: Baseline, 16 weeks, and 32 weeks
measure: Functional Movement Screening Score
timeFrame: Baseline, 16 weeks, and 32 weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Children's Health
state: California
Study officials:
affiliation: Stanford Children's Hospital
name: Elif Seda Selamet Tierney, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen AC, Ramirez FD, Rosenthal DN, Couch SC, Berry S, Stauffer KJ, Brabender J, McDonald N, Lee D, Barkoff L, Nourse SE, Kazmucha J, Wang CJ, Olson I, Selamet Tierney ES. Healthy Hearts via Live Videoconferencing: An Exercise and Diet Intervention in Pediatric Heart Transplant Recipients. J Am Heart Assoc. 2020 Feb 4;9(3):e013816. doi: 10.1161/JAHA.119.013816. Epub 2020 Jan 24.