Clinical trial NCT01822769: Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease
Official title: Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Heart Defects, Congenital
Keywords: congenital heart disease
adult congenital heart disease
cardiac rehabilitation
cardiopulmonary rehabilitation
exercise
cardiopulmonary exercise testing
peak vO2
quality of life
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2013-04-02
Enrollment: 28
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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%

Primary outcomes:
measure: Change in aerobic exercise capacity (peak VO2)
timeFrame: Baseline to 3 months (primary)
Secondary outcomes:
measure: Change in quality of life measurement
timeFrame: Baseline to 3 months (primary)
Other outcomes:
measure: Change in peak cardiac output and its components (SV/HR)
timeFrame: Baseline to 3 months (primary)
measure: Mechanism of change in peak VO2
timeFrame: Baseline to 3 months (primary)
measure: Change in ventilatory efficiency
timeFrame: Baseline to 3 months (primary)
measure: Change in strength (dynamometry)
timeFrame: Baseline to 3 months (primary)
measure: Change in pulse wave velocity
timeFrame: Baseline to 3 months
measure: Change in circulating biomarkers
timeFrame: Baseline to 3 months (primary)
measure: Change in markers of pulse reflection
timeFrame: Baseline to 3 months
measure: Incidence of arrhythmia and other adverse events during cardiopulmonary rehabilitation
timeFrame: Baseline to 3 months
measure: Change in physical activity
timeFrame: Baseline to 3 months
measure: Change in markers of ventricular function
timeFrame: Baseline to 3 months
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital, Brigham and Women's Hospital
name: Alexander Opotowsky
role: PRINCIPAL_INVESTIGATOR
References: