Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Virtual group aerobic training program | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group Exercise Program | Other | At-home, aerobic group exercise program facilitated by exercise physiologist via video format, 3 times a week for 16 weeks. |
|
| 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 |
| 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. |
Not provided
Inclusion Criteria for Patients
Exclusion Criteria for Patients
Inclusion Criteria for Parents
Exclusion Criteria for Parents
- Unwilling to complete questionnaires
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Edelson, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |