Congenital Heart DiseaseNCT05454501
The Effects of Telerehabilitation and Exercise Training in Pediatric Arrhythmia Patients With Pacemakers
A study testing Exercise Training and Patient Education in people with Congenital Heart Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Exercise Training and Patient Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 May 2022to 2 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
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
About this study
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
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.
Read the 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.
- Conditions
- Congenital Heart Disease
- Being tested
- Exercise Training, Patient Education
- Keywords
- pacemaker, physical activity, exercise, live videoconferencing, quality of life, cardiac rehabilitation
- Medical subject headings
- Heart Defects, Congenital, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingOther
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.
Patient EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Patient Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of steps
It will be evaluated with an activity tracker
Measured: 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.
Measured: 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.
Measured: A week before before starting the training and after 8 weeks training. Change from baseline to 8 weeks.
Secondary outcomes (2)
peripheral muscle strength
hand dynamometer
Measured: 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
Measured: A week before before starting the training and after 8 weeks training. Change from baseline to 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start31 May 2022
- Primary completion2 Apr 2025
- Study completion2 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sena Teber, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454501
- Sponsor's protocol ID
- E-22481095-020-1222
- Status last verified
- May 2025
- First submitted
- 31 May 2022
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05454501
- Acronym / sponsor ID
- E-22481095-020-1222
- Conditions
- Congenital Heart Disease
- Keywords
- pacemaker, physical activity, exercise, live videoconferencing, quality of life, cardiac rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- 2 Apr 2025 (actual)
- Study completion
- 2 May 2025 (actual)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Training | Active comparator | Other: Exercise Training8-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. |
| Patient Education | Active comparator | Other: Patient EducationPatients 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. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise TrainingFor 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. | Other | Exercise Training |
| Patient EducationAfter 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. | Other | Patient Education |
Primary outcome
Number of steps
Time frame: for 7 consecutive days before and after training days. Change from baseline to 8 weeks.
It will be evaluated with an activity tracker
Perceived effort, maximum workload and heart rate reserve
Time frame: A week before before starting the training and after 8 weeks training. Change from baseline to 8 weeks.
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
Time frame: A week before before starting the training and after 8 weeks training. Change from baseline to 8 weeks.
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.
2 secondary outcomes
peripheral muscle strength
Time frame: A week before before starting the training and after 8 weeks training. Change from baseline to 8 weeks.
health related quality of life
Time frame: A week before before starting the training and after 8 weeks training. Change from baseline to 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Congenital Heart Disease
Not yet recruiting
Autologous Thymus Transplant in Children With Congenital Heart Disease: A Pilot Study
Congenital Heart Disease (CHD)
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
RecruitingObservational study
The CACHE Study: Coronary Artery Care in HaEmophilia
Haemophilia, Cardiovascular Diseases
RecruitingObservational study
Essen Amyloidosis Registry
Amyloidosis; Systemic, Amyloidosis Cardiac
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training and Patient Education in people with Congenital Heart Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of steps (time frame: for 7 consecutive days before and after training days. Change from baseline to 8 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.