Congenital Heart Disease in Children Clinical Trial
Official title:
Remotely Delivered Cardiac Rehabilitation for Adolescents With Congenital Heart Disease
The goal of this randomized controlled trial is to evaluate the effectiveness of video conferencing for the delivery of live-supervised, real-time cardiac rehabilitation (CR) exercise training to groups of adolescents with congenital heart disease (CHD) in their homes. Participants will be randomized to either the remote cardiac rehab (RCR) group or active control group. The RCR group will participate in live, group-based exercise training (3-5 participants per exercise session), in their homes 3 days per week for 45 minutes over 12-weeks. Exercise sessions will be led and supervised by a live health coach via telehealth video technology. The active control group will be provided informational handouts on health exercise for their cardiac diagnosis. The primary aim is to compare between group changes (0-12-weeks) in cardiorespiratory fitness (VO2peak). Secondary aims are to compare between group changes (0-12-weeks) in cardiac function (echocardiography), lean body mass, and physical frailty. Exploratory aims will compare between group changes (0-12-weeks) in physical function, quality of life, skeletal muscle function, and physical activity self-efficacy. Additionally, exploratory aims will explore the impact of demographic characteristics, program participation, program satisfaction, and daily physical activity on changes in cardiorespiratory fitness.
This randomized controlled trial will evaluate the effectiveness of live, in-home, group-based cardiac rehabilitation (CR) exercise training compared to standard care (active) control. Participants will include adolescents (age 12-19 years) with one of three congenital heart disease (CHD) diagnoses: Fontan (single ventricle) circulation, Tetralogy of Fallot, or dextro-transposition of the great vessels. Following baseline outcomes testing, participants will be computer randomized (with equal stratification by CHD diagnosis and biologic sex) to either the remote cardiac rehab (RCR) group (n=~37) or the active control group (n=~37). Participants randomized to the RCR group will participate in 12-weeks of live-supervised exercise training (36 sessions total) from their respective homes led by a trained health coach via telehealth video technology. RCR participants will initially engage in a 2-week ramp-up period (1-1 or small groups, 6-sessions total) with a live health coach, followed by 10-weeks of group-based (3-5 participants, 30 sessions total) exercise training where participants will be able to interact with the health coach and other participants. Participants in the RCR group will be asked to attend and participate in exercise sessions 3 days per week for 45-minutes. Exercise session intensity will be consistent with a heart rate of 60-75% of their VO2peak, will consist of a mix of flexibility, aerobic, and anaerobic exercise, and will be facilitated by a small set of exercise equipment (e.g., resistance bands, cones, medicine balls) provided to participants. Participants randomized to the active control group will be provided handouts that describe exercises consistent with the physical activity recommendations for youth. The total intervention period for both groups will be 12-weeks. Primary, secondary, and exploratory outcomes will be measured at baseline and 12-13-weeks following randomization. Additionally, participants in both groups will be provided a consumer grade wrist-worn physical activity monitor, where participants will be encouraged to wear throughout the 12-week intervention period and beyond for a minimum of 6-months. Participants randomized to the active control group will be provided the opportunity to participate in the RCR exercise training once enrollment goals are met. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT05975658 -
WIReD: Wireless Interstage Remote Device Study
|
||
| Completed |
NCT05546983 -
How to Report Postoperative Outcomes After a Paediatric Cardiac Surgery ?
|
||
| Completed |
NCT03229538 -
STeroids to REduce Systemic Inflammation After Infant Heart Surgery
|
Phase 3 | |
| Completed |
NCT05579964 -
The Role of Dexmedetomidine as Myocardial Protector in Pediatric Cardiac Surgery Total Correction of Tetralogy of Fallot
|
Phase 2/Phase 3 | |
| Recruiting |
NCT05128084 -
Amotosalen and Platelet Transfusion in Pediatric Heart Surgery
|
||
| Recruiting |
NCT04604418 -
Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures
|
||
| Completed |
NCT05778240 -
Adherence to Palivizumab Prophylaxis
|
N/A | |
| Completed |
NCT04666857 -
Family Centred Early Intervention of Infants With Congenital Heart Disease
|
N/A | |
| Terminated |
NCT03136900 -
Impact on the Nitrogen Balance, Autonomy, Safety and Tolerance of Enteral Diets Made of With Nutrilon Without Lactose® Fortified by Concentration Versus by Maltodextrin and Oil Supplementation,After Surgery for Congenital Heart Disease, in Infants.
|
N/A | |
| Recruiting |
NCT05910320 -
Evaluation of an Investigational Wearable Vital Signs Monitoring Device in Healthy Infants
|
N/A | |
| Not yet recruiting |
NCT05778175 -
Common Cases in Pediatric Intensive Care in Assuit University Cardiology Institute, a Clinical Audit
|
||
| Completed |
NCT05284500 -
Predictive Pre and Peroperative Factors for MODS-2 in Pediatric Cardiac Surgery
|
||
| Completed |
NCT04295239 -
Non-invasive Monitoring of Cerebral Self-regulation in Perioperative Neonatal Cardiac Surgery
|
N/A | |
| Completed |
NCT05142046 -
Influence of Intraoperative Fluid Balance on the Incidence of Adverse Events in Pediatric Cardiac Surgery
|
||
| Recruiting |
NCT04040452 -
Continuous vs Intermittent Ketorolac for Pain Control in Peds CV Surgery
|
Phase 4 | |
| Not yet recruiting |
NCT06431269 -
Feasibility and Efficiency of Screening for Neurodevelopmental Disorders by an Advanced Practice Nurse in Children With Congenital Heart Disease
|
N/A | |
| Recruiting |
NCT05268094 -
Comparison of Methods of Pulmonary Blood Flow Augmentation in Neonates: Shunt Versus Stent (The COMPASS Trial)
|
N/A | |
| Recruiting |
NCT04315610 -
Personalized Mobile App for Parents of Infants With Cardiac Disease
|
N/A | |
| Completed |
NCT04018079 -
Left Ventricular Dysfunction Post-surgical Patent Ductus Arteriosus Ligation in Children: Predictor Factors Analysis
|
||
| Recruiting |
NCT05496803 -
Impact of Systematic Nursing Guidance on the Psychological Effects of Parents of Children With Cardiac Catheterization.
|
N/A |