Clinical trial NCT05454501: The Effects of Telerehabilitation and Exercise Training in Pediatric Arrhythmia Patients With Pacemakers
Official title: The Effects of Telerehabilitation and Exercise Training on Physical Activity, Exercise Capacity, Muscle Strength and Quality of Life in Pediatric Arrhythmia Patients With Pacemakers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Heart Disease
Keywords: pacemaker
physical activity
exercise
live videoconferencing
quality of life
cardiac rehabilitation
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2022-07-12
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* stable clinical condition (having a medical examination in the last three months, including an ECG and an echocardiogram),
* living with at least one parent or caregiver who can support them at home

Exclusion Criteria:

* To have any neurological, advanced orthopedic problems, any other systemic disease or acute infection,
* To use anticoagulant drugs,
* To have Down syndrome,
* Cannot cooperate with the video conference system and measurements

Primary outcomes:
measure: Number of steps
timeFrame: for 7 consecutive days before and after training days. Change from baseline to 8 weeks.
measure: Perceived effort, maximum workload and heart rate reserve
timeFrame: A week before before starting the training and after 8 weeks training. Change from baseline to 8 weeks.
measure: 6 Minute Walk Test (6MWT) Walking Distance
timeFrame: A week before before starting the training and after 8 weeks training. Change from baseline to 8 weeks.
Secondary outcomes:
measure: peripheral muscle strength
timeFrame: A week before before starting the training and after 8 weeks training. Change from baseline to 8 weeks.
measure: health related quality of life
timeFrame: A week before before starting the training and after 8 weeks training. Change from baseline to 8 weeks.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit and Hacettepe University Faculty of Medicine, Department of Pediatrics, Department of Pediatric Cardiology
Study officials:
References: