Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT05398744
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.
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Notify Me12 year–18 year
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for Patients
Exclusion criteria
for Patients
Inclusion criteria
for Parents
Exclusion criteria
for Parents
At-home, aerobic group exercise program facilitated by exercise physiologist via video format, 3 times a week for 16 weeks.
Time frame: 16 weeks
Attendance at assigned training sessions
Time frame: 24 weeks
Days of logged activity on the MyHeart application
Time frame: 24 weeks
Participants' attendance at biweekly meetings with exercise physiologist
Time frame: 24 weeks
Time spent at target heart rate
Time frame: 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.
Time frame: 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.
Time frame: 24 weeks
Exercise barriers will be measured by analysis of survey responses related to physical activity practices
Time frame: 24 weeks
Participants' overall program satisfaction will be analyzed by review of completed post-intervention questionnaires
Children's Hospital of Philadelphia
Other
MIGHTEE: Motivational Interviewing and Group Heart Transplant Exercise and Education: A Pilot Study
Acronym: MIGHTEE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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