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Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01822769
Recruitment Status : Completed
First Posted : April 2, 2013
Last Update Posted : January 25, 2018
Information provided by (Responsible Party):
Alexander Opotowsky, Boston Children’s Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Congenital Heart Disease Heart Defects, Congenital Other: Cardiopulmonary rehabilitation Other: Standard of care Not Applicable

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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

Resource links provided by the National Library of Medicine

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.
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

Primary Outcome Measures :
  1. Change in aerobic exercise capacity (peak VO2) [ Time Frame: Baseline to 3 months (primary) ]

Secondary Outcome Measures :
  1. Change in quality of life measurement [ Time Frame: Baseline to 3 months (primary) ]

Other Outcome Measures:
  1. Change in peak cardiac output and its components (SV/HR) [ Time Frame: Baseline to 3 months (primary) ]
  2. 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.

  3. Change in ventilatory efficiency [ Time Frame: Baseline to 3 months (primary) ]
  4. Change in strength (dynamometry) [ Time Frame: Baseline to 3 months (primary) ]
  5. Change in pulse wave velocity [ Time Frame: Baseline to 3 months ]
  6. Change in circulating biomarkers [ Time Frame: Baseline to 3 months (primary) ]
  7. Change in markers of pulse reflection [ Time Frame: Baseline to 3 months ]
  8. Incidence of arrhythmia and other adverse events during cardiopulmonary rehabilitation [ Time Frame: Baseline to 3 months ]
  9. Change in physical activity [ Time Frame: Baseline to 3 months ]
    Survey and accelerometry

  10. Change in markers of ventricular function [ Time Frame: Baseline to 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
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%

Information from the National Library of Medicine

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 identifier (NCT number): NCT01822769

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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
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Principal Investigator: Alexander Opotowsky Boston Children's Hospital, Brigham and Women's Hospital

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Responsible Party: Alexander Opotowsky, Assistant Professor, Boston Children’s Hospital 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
cardiopulmonary exercise testing
peak vO2
quality of life

Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Congenital Abnormalities
Cardiovascular Diseases
Cardiovascular Abnormalities