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

Not Applicable

Completed

• Conditions: Physical Activity; Attitude to Health; Vascular; Change; Health Behavior; Dietary Modification
• Interventions: Other: On-Line Diet and Exercise Intervention

• Registration Number: NCT02519946
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-30
• Study Start: 2015-08
• Study First Submitted QC: 2015-08-06
• Study First Posted: 2015-08-11
• Primary Completion: 2018-12-31
• Study Completion: 2018-12-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

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Exclusion Criteria

• Acute illness
• Latex allergy
• Document transplant rejection < 3 months
• Re-transplantation or multi-organ transplantation
• Malignancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
On-Line Diet and Exercise Intervention	On-Line Diet and Exercise Intervention	-

Primary Outcome Measures

Name	Time	Method
Change in Endothelial Pulse Amplitude Testing Index	Baseline, 16 weeks, and 32 weeks	Test of endothelial function

Secondary Outcome Measures

Name	Time	Method
Arterial Tonometry	Baseline, 16 weeks, and 32 weeks
Carotid Artery Imaging	Baseline, 16 weeks, and 32 weeks
Fasting Low-Density Lipoprotein Level	Baseline, 16 weeks, and 32 weeks
Volume of Oxygen Consumed at Maximal Exertion	Baseline, 16 weeks, and 32 weeks
Physical and Psychosocial Health Questionnaire Scores	Baseline, 16 weeks, and 32 weeks	Both parents and patients will be asked to complete this questionnaire
Functional Movement Screening Score	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.

Trial Locations

Locations (1)

Stanford Children's Health; 🇺🇸 Palo Alto, California, United States