Motivational Interviewing and Group Heart Transplant Exercise and Education: A Pilot Study
- Conditions
- Orthotopic Heart Transplant
- Interventions
- Other: Group Exercise Program
- Registration Number
- NCT05398744
- Lead Sponsor
- Children's Hospital of Philadelphia
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Virtual group aerobic training program Group Exercise 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.
- Primary Outcome Measures
Name Time Method Study feasibility assessed by participation in training sessions 16 weeks Attendance at assigned training sessions
Study feasibility evaluated by participants' engagement on the activity monitor application 24 weeks Days of logged activity on the MyHeart application
Study feasibility assessed by participants' engagement with exercise physiologist 24 weeks Participants' attendance at biweekly meetings with exercise physiologist
- Secondary Outcome Measures
Name Time Method Physical activity of participants 24 weeks Time spent at target heart rate
Perceived exercise barriers or exercise barriers 24 weeks Exercise barriers will be measured by analysis of survey responses related to physical activity practices
Participants' overall program satisfaction 24 weeks Participants' overall program satisfaction will be analyzed by review of completed post-intervention questionnaires
Health Related Quality of life 24 weeks 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.
Psychological well-being 24 weeks 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.
Trial Locations
- Locations (1)
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States