Clinical Trials Logo

Clinical Trial Summary

There is no study evaluating online exercise training and results in children with pacemakers. This study investigates the effects of group exercise training performed via computer online videoconferencing in pediatric arrhythmia patients with pacemakers. Pediatric arrhythmia patients aged 6-18 years with a pacemaker, stable clinically, and living with at least one parent or caregiver who can support them at home will be included in the study. Eligible patients will be randomly divided into two groups. After the face-to-face evaluation session, those in the intervention group will receive real-time online exercise training for 30 minutes, three days a week, with a peer group of 5-6 people for eight weeks. Physical activity will be monitored for seven days before starting the exercise and seven days after the training is completed. After the first face-to-face evaluation session, patients in the control group and their families will receive a 1-hour disease- and exercise-specific patient education program. Information brochures containing physical activity and exercise recommendations will be given. They will be followed up with weekly phone calls throughout the study period.


Clinical Trial Description

It is known that physical activity and exercise have long-term beneficial effects on preventing atherosclerotic cardiovascular diseases, dyslipidemia, obesity, hypertension, osteoporosis, and type 2 diabetes, frequently seen in sedentary individuals. Various exercise training programs are safe and feasible and improve functional outcome measures in this patient population. Walking distance, peak oxygen consumption, and increased physical activity were observed in these patients with exercise training. Increasing physical activity in children is also associated with gross motor performance development and positive emotional, social, and intellectual development. The probability of being a sedentary adult was very low in congenital heart patients who do sports from an early age. Universal reports drew attention to the importance of exercise and physical activities in children with heart disease and stated that they should be encouraged. Paradoxically, only a minority of children with heart disease receive physical activity counseling. Children with pacemakers have similar potential to improve their physical fitness through physical activity as their healthy peers. However, children often experience an uncertainty about what physical activities should be recommended and how the intensity of exercise should be, and they are brought up with overprotective attitudes. This encourages children to inactivity and causes them to feel inadequacy and fear. In addition, patient and family concerns about the particular vulnerability of children with pacemakers; may exacerbate social isolation and physical inactivity more than the general population. . Exercise training may be the most crucial strategy to improve functional capacity, increase physical activity and reduce the risk of future cardiovascular events. Although consensus reports indicated that exercise should be encouraged and performed regularly in these patients, it is not a common practice. Among the possible reasons; are logistical problems, costs, and parental concern about adverse events. There is a need to evaluate the effects of rehabilitation programs that can connect safely and inexpensively with these patients, including those living geographically far from rehabilitation centers. Home-based exercise approaches can be preferred as a safe, feasible, and beneficial alternative to supervised cardiac rehabilitation for all age groups with congenital hearth disease. The effectiveness of online exercise programs provided or supported through the Internet and related technologies is safe for children to participate in and improve compliance. The potential of online exercise programs in children with congenital hearth disease remains largely unexplored. Although no study evaluates exercise training and results in pediatric arrhythmia patients with pacemakers, the subject is open to research. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05454501
Study type Interventional
Source Hacettepe University
Contact
Status Enrolling by invitation
Phase N/A
Start date May 31, 2022
Completion date September 2023

See also
  Status Clinical Trial Phase
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT04992793 - Paediatric Brain Injury Following Cardiac Interventions
Recruiting NCT05213598 - Fontan Associated Liver Disease and the Evaluation of Biomarkers for Disease Severity Assessment
Completed NCT04136379 - Comparison of Home and Standard Clinic Monitoring of INR in Patients With CHD
Completed NCT04814888 - 3D Airway Model for Pediatric Patients
Recruiting NCT04920643 - High-exchange ULTrafiltration to Enhance Recovery After Pediatric Cardiac Surgery Phase 2/Phase 3
Completed NCT05934578 - Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training N/A
Recruiting NCT06041685 - Effect of Local Warming for Arterial Catheterization in Pediatric Anesthesia N/A
Recruiting NCT05902013 - Video Laryngoscopy Versus Direct Laryngoscopy for Nasotracheal Intubation N/A
Not yet recruiting NCT05687292 - Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery
Not yet recruiting NCT05524324 - Cardiac Resynchronization Therapy in Adult Congenital Heart Disease With Systemic Right Ventricle: RIGHT-CRT N/A
Completed NCT02746029 - Cardiac Murmurs in Children: Predictive Value of Cardiac Markers
Completed NCT03119090 - Fontan Imaging Biomarkers (FIB) Study
Completed NCT02537392 - Multi-micronutrient Supplementation During Peri-conception and Congenital Heart Disease N/A
Recruiting NCT02258724 - Swiss National Registry of Grown up Congenital Heart Disease Patients
Completed NCT01966237 - Milrinone Pharmacokinetics and Acute Kidney Injury
Terminated NCT02046135 - Sodium Bicarbonate to Prevent Acute Kidney Injury in Children Undergoing Cardiac Surgery Phase 2
Recruiting NCT01184404 - Bosentan Improves Clinical Outcome of Adults With Congenital Heart Disease or Mitral Valve Lesions Who Undergo CArdiac Surgery N/A
Completed NCT01548950 - Drug Therapy and Surgery in Congenital Heart Disease With Pulmonary Hypertension N/A
Completed NCT01821287 - Nutritional Failure in Infants With Single Ventricle Congenital Heart Disease N/A