Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Study Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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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 ]

Eligibility Criteria

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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%

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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