Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease

Boston Children's Hospital28 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Congenital Heart Disease Heart Defects, Congenital

Interventions

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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%

Outcomes

Primary Outcomes

Change in aerobic exercise capacity (peak VO2)

Time frame: Baseline to 3 months (primary)

Secondary Outcomes

Change in quality of life measurement