Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease

Study Overview
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Brief Summary
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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.

Official Title
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Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease

Conditions
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Congenital Heart Disease, Heart Defects, Congenital

Intervention / Treatment
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* Other: Cardiopulmonary rehabilitation
* Other: Standard of care


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiopulmonary rehabilitation<br>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. | Other: Cardiopulmonary rehabilitation<br>* See Arm Description<br>|
| Other: Standard of care<br>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). | Other: Standard of care<br>* See Arm Description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in aerobic exercise capacity (peak VO2) |  | Baseline to 3 months (primary) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life measurement |  | Baseline to 3 months (primary) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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congenital heart disease, adult congenital heart disease, cardiac rehabilitation, cardiopulmonary rehabilitation, exercise, cardiopulmonary exercise testing, peak vO2, quality of life