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

Physical Activity Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02519946
• Other study ID #: 15GRNT25680030
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: September 2019
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Attitude to Health
• Dietary Modification
• Health Behavior
• Physical Activity
• Vascular; Change

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.

Locations

Country	Name	City	State
United States	Stanford Children's Health	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Endothelial Pulse Amplitude Testing Index	Test of endothelial function	Baseline, 16 weeks, and 32 weeks
Secondary	Arterial Tonometry		Baseline, 16 weeks, and 32 weeks
Secondary	Carotid Artery Imaging		Baseline, 16 weeks, and 32 weeks
Secondary	Fasting Low-Density Lipoprotein Level		Baseline, 16 weeks, and 32 weeks
Secondary	Volume of Oxygen Consumed at Maximal Exertion		Baseline, 16 weeks, and 32 weeks
Secondary	Physical and Psychosocial Health Questionnaire Scores	Both parents and patients will be asked to complete this questionnaire	Baseline, 16 weeks, and 32 weeks
Secondary	Functional Movement Screening Score	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