- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02519946
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
-
-
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
|
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
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.
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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