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

NCT05454501 | Completed

• 1 other identifier: E-22481095-020-1222
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

pacemaker; physical activity; exercise; live videoconferencing; quality of life; cardiac rehabilitation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• peripheral muscle strength

  A week before before starting the training and after 8 weeks training. Change from baseline to 8 weeks.

• health related quality of life

  A week before before starting the training and after 8 weeks training. Change from baseline to 8 weeks.

Study Arms (2)

Exercise Training

ACTIVE COMPARATOR

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

Patient Education

ACTIVE COMPARATOR

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

Interventions

Exercise Training OTHER

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.

Exercise Training

Patient Education OTHER

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.

Patient Education

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

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

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Motor Activity

Interventions

Exercise; Patient Education as Topic

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: July 12, 2022
• Study Start: May 31, 2022
• Primary Completion: April 2, 2025
• Study Completion: May 2, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-05

Locations

TU (1)