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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Orthotopic Heart Transplant

Intervention / Treatment
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* Other: Group Exercise Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual group aerobic training program<br>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. | Other: Group Exercise Program<br>* At-home, aerobic group exercise program facilitated by exercise physiologist via video format, 3 times a week for 16 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study feasibility assessed by participation in training sessions | Attendance at assigned training sessions | 16 weeks | 
| Study feasibility evaluated by participants' engagement on the activity monitor application | Days of logged activity on the MyHeart application | 24 weeks | 
| Study feasibility assessed by participants' engagement with exercise physiologist | Participants' attendance at biweekly meetings with exercise physiologist | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity of participants | Time spent at target heart rate | 24 weeks | 
| Health Related Quality of life | Health related quality of life (HRQL) will be measured by participants' responses to Pediatric Quality of Life (PEDSQL) questionnaire, generating scores from 0-100 with a higher score indicating better quality of life. | 24 weeks | 
| Psychological well-being | Psychological well-being will be evaluated by participants' responses on questionnaires using Patient Reported Outcome Measurement Information System (PROMIS). PROMIS measures generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population (usually U.S. general population) with a higher score indicating more of the psychological concept being measured. | 24 weeks | 
| Perceived exercise barriers or exercise barriers | Exercise barriers will be measured by analysis of survey responses related to physical activity practices | 24 weeks | 
| Participants' overall program satisfaction | Participants' overall program satisfaction will be analyzed by review of completed post-intervention questionnaires | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Group Exercise, OHT, Aerobic Exercise, Motivational interviewing