Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease
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ClinicalTrials.gov Identifier: NCT01822769 |
Recruitment Status
:
Completed
First Posted
: April 2, 2013
Last Update Posted
: January 25, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Congenital Heart Disease Heart Defects, Congenital | Other: Cardiopulmonary rehabilitation Other: Standard of care | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease |
Study Start Date : | April 2013 |
Actual Primary Completion Date : | August 2016 |
Actual Study Completion Date : | December 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: Cardiopulmonary rehabilitation
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.
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Other: Cardiopulmonary rehabilitation
See Arm Description
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Standard of care
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).
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Other: Standard of care
See Arm Description
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- Change in aerobic exercise capacity (peak VO2) [ Time Frame: Baseline to 3 months (primary) ]
- Change in quality of life measurement [ Time Frame: Baseline to 3 months (primary) ]
- Change in peak cardiac output and its components (SV/HR) [ Time Frame: Baseline to 3 months (primary) ]
- Mechanism of change in peak VO2 [ Time Frame: Baseline to 3 months (primary) ]Cardiac output will be assessed and O2 delivery/extraction will be estimated to define mechanisms of improvement in exercise capacity.
- Change in ventilatory efficiency [ Time Frame: Baseline to 3 months (primary) ]
- Change in strength (dynamometry) [ Time Frame: Baseline to 3 months (primary) ]
- Change in pulse wave velocity [ Time Frame: Baseline to 3 months ]
- Change in circulating biomarkers [ Time Frame: Baseline to 3 months (primary) ]
- Change in markers of pulse reflection [ Time Frame: Baseline to 3 months ]
- Incidence of arrhythmia and other adverse events during cardiopulmonary rehabilitation [ Time Frame: Baseline to 3 months ]
- Change in physical activity [ Time Frame: Baseline to 3 months ]Survey and accelerometry
- Change in markers of ventricular function [ Time Frame: Baseline to 3 months ]

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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%

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01822769
United States, Massachusetts | |
Boston Children's Hospital | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Alexander Opotowsky | Boston Children's Hospital, Brigham and Women's Hospital |
Responsible Party: | Alexander Opotowsky, Assistant Professor, Boston Children's Hospital |
ClinicalTrials.gov Identifier: | NCT01822769 History of Changes |
Other Study ID Numbers: |
P00005391 |
First Posted: | April 2, 2013 Key Record Dates |
Last Update Posted: | January 25, 2018 |
Last Verified: | January 2018 |
Keywords provided by Alexander Opotowsky, Boston Children's Hospital:
congenital heart disease adult congenital heart disease cardiac rehabilitation cardiopulmonary rehabilitation |
exercise cardiopulmonary exercise testing peak vO2 quality of life |
Additional relevant MeSH terms:
Heart Diseases Heart Defects, Congenital Congenital Abnormalities Cardiovascular Diseases Cardiovascular Abnormalities |