Status:
COMPLETED
Motivational Interviewing and Group Heart Transplant Exercise and Education: A Pilot Study
Lead Sponsor:
Children's Hospital of Philadelphia
Conditions:
Orthotopic Heart Transplant
Eligibility:
All Genders
12-18 years
Phase:
NA
Brief Summary
The aim of this 16-week group aerobic training program, delivered remotely via video-conferencing, is to assess program feasibility, and determine if program increases physical activity in adolescents...
Detailed Description
Orthotopic heart transplant (OHT) is the definitive therapy for children with cardiac disease, however, survival after transplant is limited, and quality of life after transplant is less than healthy ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Patients
- Age 12-18 years old
- More than 12 months removed from their initial heart transplant
- Agreement to participate in study protocol and willing/able to return for follow-up.
- Access to computer and/or internet for uploading health data from wearable electronic activity monitor.
- Access to an electronic device (phone, tablet, or computer) with a camera feature, microphone, and the capacity to use Zoom, the virtual platform which will stream the group exercise session.
- Clinical EKG with normal sinus rhythm
- English language proficiency
- Exclusion Criteria for Patients
- Patients who are restricted from exercise
- Patients who are pregnant
- History of pharmaceutically treated rejection within the prior 6 months
- Physical or behavioral conditions that would prevent them from participating in aerobic exercise (i.e., significant motor disability, illness precluding participation in the exercise regimen as described).
- Inability to complete a standard maximal exercise stress test (as defined by those who did not achieve an respiratory exchange ratio (RER)\>1.1 and who gave submaximal effort according to exercise physiologist performing EST)
- EKG or ambulatory rhythm monitor performed within the last 12 months which shows 2nd or 3rd degree atrioventricular (AV) block
- Patients with a medication change after their baseline EST expected to affect their heart rate response to exercise (i.e. initiation/discontinuation of a beta-blocker, beta-agonist during exercise, or ivabradine)
- Pacemaker
- Inclusion Criteria for Parents
- Parent of a patient that fits all inclusionary/exclusionary eligibility criteria
- English language proficiency at least at a 5th grade level or for limited English proficient (LEP) parents, preferred language proficiency of at least a 5th grade level
- Exclusion Criteria for Parents
- \- Unwilling to complete questionnaires
Exclusion
Key Trial Info
Start Date :
July 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2024
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT05398744
Start Date
July 13 2022
End Date
June 26 2024
Last Update
September 24 2024
Active Locations (1)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104