Skip to main content
OpenTrials
Completed

NCT Number: NCT02519946

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vascular; Change Adolescent Behavior Attitude to Health Behavior Child Behavior Dietary Modification Health Behavior Motor Activity Physical Activity

Age range

9 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Children's Health

Palo Alto, California, 94306, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

On-Line Diet and Exercise Intervention

Other

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.

Primary outcomes

  1. Change in Endothelial Pulse Amplitude Testing Index

    Time frame: Baseline, 16 weeks, and 32 weeks

    Test of endothelial function

Secondary outcomes

  1. Arterial Tonometry

    Time frame: Baseline, 16 weeks, and 32 weeks

  2. Carotid Artery Imaging

    Time frame: Baseline, 16 weeks, and 32 weeks

  3. Fasting Low-Density Lipoprotein Level

    Time frame: Baseline, 16 weeks, and 32 weeks

  4. Volume of Oxygen Consumed at Maximal Exertion

    Time frame: Baseline, 16 weeks, and 32 weeks

  5. Physical and Psychosocial Health Questionnaire Scores

    Time frame: Baseline, 16 weeks, and 32 weeks

    Both parents and patients will be asked to complete this questionnaire

  6. Functional Movement Screening Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Aug 11, 2015
Registry last updated
Sep 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.