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The hypothesis of this study is that participation in a formal cardiopulmonary rehabilitation program improves aerobic exercise capacity and quality of life over the medium term for patients with congenital heart disease with reduced exercise capacity. To test this hypothesis, subjects will be randomized to either receive a 12-week cardiopulmonary rehabilitation program or standard of care, with interval testing of aerobic capacity and other physiologic markers improved fitness, as well as assessment of quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiopulmonary rehabilitation | Experimental | The subjects will attend 2 sessions each week for 12 weeks. Each session will be approximately 2 hours in duration, consisting of both exercise (aerobic and strength,~60 minutes) and education. In addition, subjects will be directed to participate in 3 weekly ~40 minute home exercise training sessions, personalized to their level of aerobic conditioning. |
|
| Standard of care | Other | Subjects randomized to standard of care will not be enrolled in a rehabilitation program, but may receive any other clinically indicated exercise training or other intervention (e.g., an exercise prescription). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiopulmonary rehabilitation | Other | See Arm Description |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in aerobic exercise capacity (peak VO2) | Baseline to 3 months (primary) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quality of life measurement | Baseline to 3 months (primary) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in peak cardiac output and its components (SV/HR) | Baseline to 3 months (primary) | |
| Mechanism of change in peak VO2 | Cardiac output will be assessed and O2 delivery/extraction will be estimated to define mechanisms of improvement in exercise capacity. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Opotowsky | Boston Children's Hospital, Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care |
| Other |
See Arm Description |
|
| Baseline to 3 months (primary) |
| Change in ventilatory efficiency | Baseline to 3 months (primary) |
| Change in strength (dynamometry) | Baseline to 3 months (primary) |
| Change in pulse wave velocity | Baseline to 3 months |
| Change in circulating biomarkers | Baseline to 3 months (primary) |
| Change in markers of pulse reflection | Baseline to 3 months |
| Incidence of arrhythmia and other adverse events during cardiopulmonary rehabilitation | Baseline to 3 months |
| Change in physical activity | Survey and accelerometry | Baseline to 3 months |
| Change in markers of ventricular function | Baseline to 3 months |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001519 | Behavior |