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Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease
This study is ongoing, but not recruiting participants.
Sponsor:
Boston Children’s Hospital
Information provided by (Responsible Party):
Alexander Opotowsky, Boston Children's Hospital
ClinicalTrials.gov Identifier:
NCT01822769
First received: March 28, 2013
Last updated: January 18, 2017
Last verified: January 2017
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Purpose
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.
| Condition | Intervention |
|---|---|
| Congenital Heart Disease Heart Defects, Congenital | Other: Cardiopulmonary rehabilitation Other: Standard of care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Outcomes Assessor Primary Purpose: Treatment |
| Official Title: | Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease |
Resource links provided by NLM:
Further study details as provided by Alexander Opotowsky, Boston Children's Hospital:
Primary Outcome Measures:
- Change in aerobic exercise capacity (peak VO2) [ Time Frame: Baseline to 3 months (primary) ]
Secondary Outcome Measures:
- Change in quality of life measurement [ Time Frame: Baseline to 3 months (primary) ]
Other Outcome Measures:
- 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 ]
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | December 2017 |
| Primary Completion Date: | August 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Other: Cardiopulmonary rehabilitation
See Arm Description
|
|
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).
|
Other: Standard of care
See Arm Description
|
Eligibility| Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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%
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01822769
Please refer to this study by its ClinicalTrials.gov identifier: NCT01822769
Locations
| United States, Massachusetts | |
| Boston Children's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
| Principal Investigator: | Alexander Opotowsky | Boston Children's Hospital, Brigham and Women's Hospital |
More Information
| Responsible Party: | Alexander Opotowsky, Assistant Professor, Boston Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT01822769 History of Changes |
| Other Study ID Numbers: |
P00005391 |
| Study First Received: | March 28, 2013 |
| Last Updated: | January 18, 2017 |
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 |
ClinicalTrials.gov processed this record on June 22, 2017