Motivational Interviewing and Group Heart Transplant Exercise and Education: A Pilot Study

NCT ID: NCT05398744

Last Updated: 2024-09-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-13
• Study Completion Date: 2024-06-26

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 after heart transplant.

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 peers'. The transplanted heart usually works well, pumping blood as well as most healthy hearts. As such, the American Heart Association recommends no specific exercise related restrictions for heart transplant recipients. Although most children have normal cardiac function after OHT, children with transplanted hearts have impaired exercise performance, and do not exercise as much as their peers. This finding is concerning, as impaired exercise tolerance is associated with reduced survival, diminished health related quality of life, and depression and anxiety. These factors negatively impact adherence, and further limit graft survival. Thus, identifying interventions that positively impact physical activity and promote graft longevity, like individualized exercise programs, should be a priority for post-transplant care.

Investigators propose that increasing physical activity in children and adolescents after OHT may be a critical modifiable method for increasing graft longevity and improving quality of life. Investigators will explore this through a pilot program. Participants will wear an activity monitor to record physical activity, parents/caregivers and participants will complete surveys, and participants will engage with psychologists and exercise physiologists.

Conditions

Orthotopic Heart Transplant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Virtual group aerobic training program

16-week, virtual group aerobic training program led by exercise physiologist. Duration: 24 weeks. Four weeks recording of baseline activity through activity monitor; 16-week virtual group aerobic training program, 3 times per week for 30 minutes; and four weeks of follow-up.

Group Type: EXPERIMENTAL

Group Exercise Program

Intervention Type: OTHER

At-home, aerobic group exercise program facilitated by exercise physiologist via video format, 3 times a week for 16 weeks.

Interventions

Group Exercise Program

At-home, aerobic group exercise program facilitated by exercise physiologist via video format, 3 times a week for 16 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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

• Unwilling to complete questionnaires

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Edelson, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Locations

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

21-018888

Identifier Type: -

Identifier Source: org_study_id