Back to resultsCardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease
Primary Purpose
Congenital Heart Disease, Heart Defects, Congenital
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiopulmonary rehabilitation
Standard of care
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Heart Disease focused on measuring congenital heart disease, adult congenital heart disease, cardiac rehabilitation, cardiopulmonary rehabilitation, exercise, cardiopulmonary exercise testing, peak vO2, quality of life
Eligibility 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%
Sites / Locations
- Boston Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Cardiopulmonary rehabilitation
Standard of care
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
Change in aerobic exercise capacity (peak VO2)
Secondary Outcome Measures
Change in quality of life measurement
Full Information
NCT ID
NCT01822769
First Posted
March 28, 2013
Last Updated
January 23, 2018
Sponsor
Boston Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01822769
Brief Title
Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease
Official Title
Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease, Heart Defects, Congenital
Keywords
congenital heart disease, adult congenital heart disease, cardiac rehabilitation, cardiopulmonary rehabilitation, exercise, cardiopulmonary exercise testing, peak vO2, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cardiopulmonary rehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care
Arm Type
Other
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Cardiopulmonary rehabilitation
Intervention Description
See Arm Description
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
See Arm Description
Primary Outcome Measure Information:
Title
Change in aerobic exercise capacity (peak VO2)
Time Frame
Baseline to 3 months (primary)
Secondary Outcome Measure Information:
Title
Change in quality of life measurement
Time Frame
Baseline to 3 months (primary)
Other Pre-specified Outcome Measures:
Title
Change in peak cardiac output and its components (SV/HR)
Time Frame
Baseline to 3 months (primary)
Title
Mechanism of change in peak VO2
Description
Cardiac output will be assessed and O2 delivery/extraction will be estimated to define mechanisms of improvement in exercise capacity.
Time Frame
Baseline to 3 months (primary)
Title
Change in ventilatory efficiency
Time Frame
Baseline to 3 months (primary)
Title
Change in strength (dynamometry)
Time Frame
Baseline to 3 months (primary)
Title
Change in pulse wave velocity
Time Frame
Baseline to 3 months
Title
Change in circulating biomarkers
Time Frame
Baseline to 3 months (primary)
Title
Change in markers of pulse reflection
Time Frame
Baseline to 3 months
Title
Incidence of arrhythmia and other adverse events during cardiopulmonary rehabilitation
Time Frame
Baseline to 3 months
Title
Change in physical activity
Description
Survey and accelerometry
Time Frame
Baseline to 3 months
Title
Change in markers of ventricular function
Time Frame
Baseline to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Opotowsky
Organizational Affiliation
Boston Children's Hospital, Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
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Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease
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