We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02519946
Recruitment Status : Completed
First Posted : August 11, 2015
Last Update Posted : September 19, 2019
Sponsor:
Information provided by (Responsible Party):
Seda Tierney, Stanford University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Vascular; Change Dietary Modification Physical Activity Health Behavior Attitude to Health Other: On-Line Diet and Exercise Intervention Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : August 2015
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in Endothelial Pulse Amplitude Testing Index [ Time Frame: Baseline, 16 weeks, and 32 weeks ]
    Test of endothelial function


Secondary Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   9 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519946


Locations
Layout table for location information
United States, California
Stanford Children's Health
Palo Alto, California, United States, 94306
Sponsors and Collaborators
Stanford University
Investigators
Layout table for investigator information
Principal Investigator: Elif Seda Selamet Tierney, MD Stanford Children's Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Seda Tierney, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT02519946    
Other Study ID Numbers: 15GRNT25680030
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Keywords provided by Seda Tierney, Stanford University:
Heart Transplantation
Tonometry
Exercise Test
Diet
Cardiovascular Physiology
Telemedicine
 Pediatrics
Health Behavior
Physical Fitness
Exercise Movement Techniques
Adolescent Behavior
Child Behavior