Congenital Heart Disease, Heart Defects, Congenital
Conditions
Keywords
congenital heart disease, adult congenital heart disease, cardiac rehabilitation, cardiopulmonary rehabilitation, exercise, cardiopulmonary exercise testing, peak vO2, quality of life
Brief summary
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.
Interventions
See Arm Description
OTHERStandard of care
See Arm Description
Sponsors
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able and willing to participate in a 12-week cardiac rehabilitation program and repeated cardiopulmonary exercise testing * pVO2≤80% predicted (impaired aerobic capacity) on baseline exercise test * congenital heart disease of at least moderate complexity
Exclusion criteria
* Cardiac intervention (cath/surg) within prior 6m * Planned cardiac intervention (cath/surg) within 12m * Formal cardiac rehabilitation within 24m * Current/recent (delivery\<90d prior) pregnancy, planned pregnancy within 12m * Active heart failure, hospitalization or major change in clinical status over prior 30d * Other recent or planned events expected to have a significant impact on exercise capacity * Baseline oxygen saturation \<92%
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in aerobic exercise capacity (peak VO2) | Baseline to 3 months (primary) |
Secondary
| Measure | Time frame |
|---|---|
| Change in quality of life measurement | Baseline to 3 months (primary) |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 peak cardiac output and its components (SV/HR) | Baseline to 3 months (primary) | — |
| Incidence of arrhythmia and other adverse events during cardiopulmonary rehabilitation | Baseline to 3 months | — |
| Change in physical activity | Baseline to 3 months | Survey and accelerometry |
| Change in markers of ventricular function | Baseline to 3 months | — |
| Change in markers of pulse reflection | Baseline to 3 months | — |
| Mechanism of change in peak VO2 | Baseline to 3 months (primary) | Cardiac output will be assessed and O2 delivery/extraction will be estimated to define mechanisms of improvement in exercise capacity. |
Countries
United States
Outcome results
None listed