Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease - Full Text View

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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Heart Diseases Rehabilitation

U.S. FDA Resources

Further study details as provided by Boston Children’s Hospital:

Primary Outcome Measures:

Change in aerobic exercise capacity (peak VO2) [ Time Frame: Baseline to 3 months (primary) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in quality of life measurement [ Time Frame: Baseline to 3 months (primary) ] [ Designated as safety issue: No ]

Other Outcome Measures:

Change in peak cardiac output and its components (SV/HR) [ Time Frame: Baseline to 3 months (primary) ] [ Designated as safety issue: No ]
Mechanism of change in peak VO2 [ Time Frame: Baseline to 3 months (primary) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
Change in strength (dynamometry) [ Time Frame: Baseline to 3 months (primary) ] [ Designated as safety issue: No ]
Change in pulse wave velocity [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
Change in circulating biomarkers [ Time Frame: Baseline to 3 months (primary) ] [ Designated as safety issue: No ]
Change in markers of pulse reflection [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
Incidence of arrhythmia and other adverse events during cardiopulmonary rehabilitation [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: Yes ]
Change in physical activity [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
Survey and accelerometry
Change in markers of ventricular function [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]


Estimated Enrollment:	60
Study Start Date:	April 2013
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	August 2015 (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

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)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Children's Hospital Boston
ClinicalTrials.gov Identifier:	NCT01822769 History of Changes
Other Study ID Numbers:	P00005391
Study First Received:	March 28, 2013
Last Updated:	August 4, 2015
Health Authority:	United States: Institutional Review Board

Keywords provided by 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 September 23, 2016