The Effects of Telerehabilitation and Exercise Training in Pediatric Arrhythmia Patients With Pacemakers
Primary Purpose
Congenital Heart Disease
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Exercise Training
Patient Education
Sponsored by
About this trial
This is an interventional prevention trial for Congenital Heart Disease focused on measuring pacemaker, physical activity, exercise, live videoconferencing, quality of life, cardiac rehabilitation
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
Sites / Locations
- 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
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Exercise Training
Patient Education
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Number of steps
It will be evaluated with an activity tracker
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.
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.
Secondary Outcome Measures
peripheral muscle strength
hand dynamometer
health related quality of life
PedsQL self-reported quality of life scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05454501
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 31, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
pacemaker, physical activity, exercise, live videoconferencing, quality of life, cardiac rehabilitation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise Training
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Patient Education
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Patient Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of steps
Description
It will be evaluated with an activity tracker
Time Frame
for 7 consecutive days before and after training days. Change from baseline to 8 weeks.
Title
Perceived effort, maximum workload and heart rate reserve
Description
Cardiorespiratory capacity will be evaluated with an effort test with a treadmill. The modified Bruce protocol will be used as the treadmill protocol.
Time Frame
A week before before starting the training and after 8 weeks training. Change from baseline to 8 weeks.
Title
6 Minute Walk Test (6MWT) Walking Distance
Description
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.
Time Frame
A week before before starting the training and after 8 weeks training. Change from baseline to 8 weeks.
Secondary Outcome Measure Information:
Title
peripheral muscle strength
Description
hand dynamometer
Time Frame
A week before before starting the training and after 8 weeks training. Change from baseline to 8 weeks.
Title
health related quality of life
Description
PedsQL self-reported quality of life scale
Time Frame
A week before before starting the training and after 8 weeks training. Change from baseline to 8 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
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
City
Ankara
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Effects of Telerehabilitation and Exercise Training in Pediatric Arrhythmia Patients With Pacemakers
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