Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease

Boston Children's Hospital

Status: Completed

Conditions: Heart Defects, Congenital; Congenital Heart Disease

Treatments: Other: Cardiopulmonary rehabilitation; Other: Standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT01822769

P00005391

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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%

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Cardiopulmonary rehabilitation

Experimental group

Description:

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.

Treatment:

Other: Cardiopulmonary rehabilitation

Standard of care

Other group

Description:

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).

Treatment:

Other: Standard of care