Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease

Completed · Not applicable

Conditions studied: Congenital Heart Disease, Heart Defects, Congenital

In brief

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.

Key facts

Study ID

NCT01822769

Run by

Boston Children's Hospital

People needed

28

Starts

2013-04-01

Expected to finish

2017-12-01

Last updated by the study team

2018-01-25

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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%

Where it is running

• Boston Children's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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