The Effects of Telerehabilitation and Exercise Training in Pediatric Arrhythmia Patients With Pacemakers

The Effects of Telerehabilitation and Exercise Training on Physical Activity, Exercise Capacity, Muscle Strength and Quality of Life in Pediatric Arrhythmia Patients With Pacemakers

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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease
• Intervention / Treatment: Other: Exercise Training; Other: Patient Education

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye)
    • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Exercise Training; 8-week real-time online exercise training will be provided. The content of the training will be aerobic based exercises, strength and flexibility exercises with warm up and cool down phases.	Other: Exercise Training; For eight weeks, they will receive real-time online exercise training for 30 minutes, three days a week, with a peer group of 5-6 people. Before starting the exercise, physical activity will be monitored for seven days.
Active Comparator: Patient Education; Patients will be given face-to-face education about their disease, the importance of physical activity and how to do it safely. They will be followed up with information leaflets and weekly phone calls.	Other: Patient Education; After the first face-to-face evaluation session, these patients and their families will receive a 1-hour patient education program specific to the disease and exercise. Information brochures containing physical activity and exercise recommendations will be given. They will be followed up with weekly phone calls throughout the study period. At the end of 8 weeks, the second evaluation interview will be held. Afterward, the patients in the control group will be able to participate in the online exercise training program if they request it.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of steps	It will be evaluated with an activity tracker	for 7 consecutive days before and after training days. Change from baseline to 8 weeks.
Perceived effort, maximum workload and heart rate reserve	Cardiorespiratory capacity will be evaluated with an effort test with a treadmill. The modified Bruce protocol will be used as the treadmill protocol.	A week before before starting the training and after 8 weeks training. Change from baseline to 8 weeks.
6 Minute Walk Test (6MWT) Walking Distance	Functional exercise capacity will be assessed with the 6 Minute Walk Test. Pre-test heart rate, blood pressure, saturation values will be evaluated during and after the test.	A week before before starting the training and after 8 weeks training. Change from baseline to 8 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
peripheral muscle strength	hand dynamometer	A week before before starting the training and after 8 weeks training. Change from baseline to 8 weeks.
health related quality of life	PedsQL self-reported quality of life scale	A week before before starting the training and after 8 weeks training. Change from baseline to 8 weeks.

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2022
• Primary Completion (Actual): April 2, 2025
• Study Completion (Actual): May 2, 2025

Study Registration Dates

• First Submitted: May 31, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: physical activity; exercise; quality of life; pacemaker; cardiac rehabilitation; live videoconferencing
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior; Heart Defects, Congenital; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Health Education; Exercise; Patient Education as Topic
• Other Study ID Numbers: E-22481095-020-1222

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No