Congenital AbnormalitiesNCT06819059
Safety and Effectiveness of a Virtual Pediatric Cardiac Rehabilitation Program or Telerehabilitation in Children With Heart Disease
A study testing Pediatric Cardiac Telerehabilitation and Fitness Tracker Only in people with Congenital Abnormalities and Pulmonary Arterial Hypertension (PAH), run by Columbia University at 1 site in United States.
Trial summary
Cardiac telerehabilitation is a much-needed pediatric therapy; however, a lack of randomized controlled trials has limited the development of and reimbursement for this valuable service. Read more about this study
- Who is it for?
- Ages 10 to 25 years
- Conditions the study is for
- Congenital Abnormalities, Pulmonary Arterial Hypertension (PAH), Orthotopic Heart Transplant
- What is being tested?
- Pediatric Cardiac Telerehabilitation and Fitness Tracker Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 1 Feb 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 10 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 10 -25 yrs
- Not participating in organized sports of physical fitness programs
- Able to follow basic directions and express symptoms
- Dx of pulmonary hypertension, congenital heart disease, and transplant programs
- Clinically stable as deemed by the referring cardiologist
Who cannot join
- Clinical instability as demonstrated by recent medication escalation (within 3 months prior to starting the program)
- Hemodynamic instability
- Significant arrhythmia or ST segment or T wave abnormalities
- End-tidal carbon dioxide less than 20 mmHg with exercise, or exercise-induced symptoms that would limit ability to participate in the intervention safely
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center - New York Presbyterian's Morgan Stanley's Children's Hospital
New York, New York, 10032
About this study
Official title: Safety and Efficacy of Pediatric Cardiac Telerehabilitation in Adolescents With Heart Disease
Cardiac telerehabilitation is a much-needed pediatric therapy; however, a lack of randomized controlled trials has limited the development of and reimbursement for this valuable service. Through this prospective, randomized controlled trial, the investigators aim to demonstrate the safety and efficacy of PCTR in a clinically diverse population of children and adolescents with heart disease.
Read the detailed description
This is a single center, prospective, randomized, controlled pilot of a pediatric cardiac telerehabilitation program in adolescents with acquired or congenital heart disease.
Because of the known benefits of exercise, controls were offered the opportunity to participate in the intervention group after completing the 12 weeks in the control group.
Participants were randomized in a 2:1 ratio (intervention: control) to maximize participation in the exercise intervention. Participants were from three core populations: primary or secondary pulmonary hypertension (PH), structural congenital heart disease (CHD), and post-orthotopic heart transplant (OHT). PCTR was "semi-supervised", where one day per week the participant exercised one-on-one with a physical therapist or exercise physiologist via virtual platform and 2 days per week they exercised independently. Participants wore an activity tracker with heart rate monitoring 24 hours a day and a single lead, chest-based electrocardiogram (ECG) device while exercising. A physician or program director reviewed ECGs after all sessions. An adult had to be available in case of an emergency during each session. Controls received weekly check-ins and a Fitbit but did not receive a formal exercise prescription. All participants underwent baseline and post-study assessments including the cardiopulmonary stress test (CPET) and questionnaires and wore their Fitbits for the duration of the study.
Compliance was measured by attendance of Zoom appointments, Fitbit activity data, Wellue single lead electrocardiogram (ECG) data, and self-reported activity performed. Efficacy was measured by CPET results, validated questionnaire data and activity levels as determined by Fitbit data.
- Conditions
- Congenital Abnormalities, Pulmonary Arterial Hypertension (PAH), Orthotopic Heart Transplant, Cardiac Rehabilitation, Pediatric Cardiology, Telehealth
- Being tested
- Pediatric Cardiac Telerehabilitation, Fitness Tracker Only
- Keywords
- Pediatric Cardiac Telerehabilitation, Pediatric Exercise, Cardiac Rehabilitation
- Medical subject headings
- Congenital Abnormalities, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pediatric Cardiac TelerehabilitationBehavioural
The program was entirely virtual except for pre and post program cardiopulmonary exercise testing. Patients were provided a stationary bicycle, hand weights, and resistance training bands. They exercised over zoom with a physical therapist or exercise physiologist weekly and were also asked to exercise independently 2x per week. Electrocardiograms (ECGs) were provided to the patients as a single lead monitor and results were shared with the study team after each session or during sessions if the patient reported symptoms. Compliance and activity data were recorded using Fitbit activity trackers.
Fitness Tracker OnlyBehavioural
Control participants were provided fitness trackers and weekly text messaging from the study team to synch their devises but no formal exercise training. They were allowed to enroll in the exercise training after completing 3 months as a control.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 is the treatment arm that receives 12 weeks of weekly cardiac telerehabilitation sessions | Experimental | The participants randomized to study Arm 1 were enrolled in the 12 weeks of cardiac telerehabilitation which included weekly one-on-one sessions with the exercise physiologist or physical therapist. Participants in this arm also received fitness activity trackers to record heart rate, active minutes, steps and sleep data. Receives: Behavioral: Pediatric Cardiac Telerehabilitation; Behavioral: Fitness Tracker Only |
| Arm 2 was the study arm for participants randomized to the control group | Active comparator | Participants randomized to Arm 2 received fitness activity trackers that provided the patient with heart rate data, steps and sleep data but received no formal exercise training. Receives: Behavioral: Fitness Tracker Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Sessions Completed
The primary outcome of this study was compliance measured by drop out rate of the cardiac rehabilitation group and any adverse events that occurred with exercise.
Measured: 12 weeks
Secondary outcomes (3)
Change in exercise time
The study will measure the change in exercise duration pre- to post-intervention.
Measured: 12 weeks
Change in Anxiety associated with exercise (ESQ -18)
The impact on anxiety associated with exercise before and after the program will be measured using the Exercise Sensitivity Questionnaire on a 0-72 scale. Lower score indicates better outcome.
Measured: 12 weeks
Change in Disease Burden by lower Quality of Life Measure
The impact of disease burden on quality of life using the PedsQL questionnaire (Pediatric Quality of Life) with a 0-60 scale, with a lower score indicating a lesser impact.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start1 May 2023
- Primary completion1 Nov 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital AbnormalitiesStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control Trial, with optional cross over for control participants to receive the treatment after completing 3 months of control data collection and post 3 month enrollment follow up testing.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aimee Layton, Columbia University
- Investigators
- Aimee M Layton, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06819059
- Sponsor's protocol ID
- AAAT7872
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We would need clearance from our institutions legal services.
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Pediatric Cardiac Telerehabilitation in Adolescents With Heart Disease
- ClinicalTrials.gov ID
- NCT06819059
- Acronym / sponsor ID
- AAAT7872
- Conditions
- Congenital Abnormalities, Pulmonary Arterial Hypertension (PAH), Orthotopic Heart Transplant, Cardiac Rehabilitation, Pediatric Cardiology, Telehealth
- Keywords
- Pediatric Cardiac Telerehabilitation, Pediatric Exercise, Cardiac Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 11 Feb 2025 (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.
Cardiac telerehabilitation is a much-needed pediatric therapy; however, a lack of randomized controlled trials has limited the development of and reimbursement for this valuable service. Through this prospective, randomized controlled trial, the investigators aim to demonstrate the safety and efficacy of PCTR in a clinically diverse population of children and adolescents with heart disease.
Detailed description
This is a single center, prospective, randomized, controlled pilot of a pediatric cardiac telerehabilitation program in adolescents with acquired or congenital heart disease.
Because of the known benefits of exercise, controls were offered the opportunity to participate in the intervention group after completing the 12 weeks in the control group.
Participants were randomized in a 2:1 ratio (intervention: control) to maximize participation in the exercise intervention. Participants were from three core populations: primary or secondary pulmonary hypertension (PH), structural congenital heart disease (CHD), and post-orthotopic heart transplant (OHT). PCTR was "semi-supervised", where one day per week the participant exercised one-on-one with a physical therapist or exercise physiologist via virtual platform and 2 days per week they exercised independently. Participants wore an activity tracker with heart rate monitoring 24 hours a day and a single lead, chest-based electrocardiogram (ECG) device while exercising. A physician or program director reviewed ECGs after all sessions. An adult had to be available in case of an emergency during each session. Controls received weekly check-ins and a Fitbit but did not receive a formal exercise prescription. All participants underwent baseline and post-study assessments including the cardiopulmonary stress test (CPET) and questionnaires and wore their Fitbits for the duration of the study.
Compliance was measured by attendance of Zoom appointments, Fitbit activity data, Wellue single lead electrocardiogram (ECG) data, and self-reported activity performed. Efficacy was measured by CPET results, validated questionnaire data and activity levels as determined by Fitbit data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Control Trial, with optional cross over for control participants to receive the treatment after completing 3 months of control data collection and post 3 month enrollment follow up testing.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 is the treatment arm that receives 12 weeks of weekly cardiac telerehabilitation sessions | Experimental | Behavioral: Pediatric Cardiac Telerehabilitation, Behavioral: Fitness Tracker OnlyThe participants randomized to study Arm 1 were enrolled in the 12 weeks of cardiac telerehabilitation which included weekly one-on-one sessions with the exercise physiologist or physical therapist. Participants in this arm also received fitness activity trackers to record heart rate, active minutes, steps and sleep data. |
| Arm 2 was the study arm for participants randomized to the control group | Active comparator | Behavioral: Fitness Tracker OnlyParticipants randomized to Arm 2 received fitness activity trackers that provided the patient with heart rate data, steps and sleep data but received no formal exercise training. |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 10 -25 yrs
- Not participating in organized sports of physical fitness programs
- Able to follow basic directions and express symptoms
- Dx of pulmonary hypertension, congenital heart disease, and transplant programs
- Clinically stable as deemed by the referring cardiologist
Key exclusion criteria (4 listed)
- Clinical instability as demonstrated by recent medication escalation (within 3 months prior to starting the program)
- Hemodynamic instability
- Significant arrhythmia or ST segment or T wave abnormalities
- End-tidal carbon dioxide less than 20 mmHg with exercise, or exercise-induced symptoms that would limit ability to participate in the intervention safely
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 |
|---|---|---|
| Pediatric Cardiac TelerehabilitationThe program was entirely virtual except for pre and post program cardiopulmonary exercise testing. Patients were provided a stationary bicycle, hand weights, and resistance training bands. They exercised over zoom with a physical therapist or exercise physiologist weekly and were also asked to exercise independently 2x per week. Electrocardiograms (ECGs) were provided to the patients as a single lead monitor and results were shared with the study team after each session or during sessions if the patient reported symptoms. Compliance and activity data were recorded using Fitbit activity trackers. | Behavioural | Arm 1 is the treatment arm that receives 12 weeks of weekly cardiac telerehabilitation sessions |
| Fitness Tracker OnlyControl participants were provided fitness trackers and weekly text messaging from the study team to synch their devises but no formal exercise training. They were allowed to enroll in the exercise training after completing 3 months as a control. | Behavioural | Arm 1 is the treatment arm that receives 12 weeks of weekly cardiac telerehabilitation sessions, Arm 2 was the study arm for participants randomized to the control group |
Primary outcome
Number of Sessions Completed
Time frame: 12 weeks
The primary outcome of this study was compliance measured by drop out rate of the cardiac rehabilitation group and any adverse events that occurred with exercise.
3 secondary outcomes
Change in exercise time
Time frame: 12 weeks
Change in Anxiety associated with exercise (ESQ -18)
Time frame: 12 weeks
Change in Disease Burden by lower Quality of Life Measure
Time frame: 12 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 11 Feb 2025.
- Individual participant dataSharing planned: Undecided. We would need clearance from our institutions legal services.
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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.
Aimee M Layton, PhD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pediatric Cardiac Telerehabilitation and Fitness Tracker Only in people with Congenital Abnormalities and Pulmonary Arterial Hypertension (PAH), run by Columbia University at 1 site in United States.
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 5 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 11 Feb 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 United States. 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 Sessions Completed (time frame: 12 weeks). 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 11 Feb 2025.