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

September 17, 2019 updated by: Seda Tierney, Stanford University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94306
        • Stanford Children's Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: On-Line Diet and Exercise Intervention
Other: On-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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arterial Tonometry
Time Frame: Baseline, 16 weeks, and 32 weeks
Baseline, 16 weeks, and 32 weeks
Carotid Artery Imaging
Time Frame: Baseline, 16 weeks, and 32 weeks
Baseline, 16 weeks, and 32 weeks
Fasting Low-Density Lipoprotein Level
Time Frame: Baseline, 16 weeks, and 32 weeks
Baseline, 16 weeks, and 32 weeks
Volume of Oxygen Consumed at Maximal Exertion
Time Frame: Baseline, 16 weeks, and 32 weeks
Baseline, 16 weeks, and 32 weeks
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
Baseline, 16 weeks, and 32 weeks
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.
Baseline, 16 weeks, and 32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Elif Seda Selamet Tierney, MD, Stanford Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

July 30, 2015

First Submitted That Met QC Criteria

August 6, 2015

First Posted (Estimate)

August 11, 2015

Study Record Updates

Last Update Posted (Actual)

September 19, 2019

Last Update Submitted That Met QC Criteria

September 17, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 15GRNT25680030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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