Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease

NCT ID: NCT01822769

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2017-12-31

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.

Conditions

Congenital Heart Disease; Heart Defects, Congenital

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cardiopulmonary rehabilitation

Intervention Type: OTHER

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).

Group Type: OTHER

Standard of care

Intervention Type: OTHER

See Arm Description

Interventions

Cardiopulmonary rehabilitation

See Arm Description

Intervention Type: OTHER

Standard of care

See Arm Description

Intervention Type: OTHER

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%

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Alexander Opotowsky

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexander Opotowsky

Role: PRINCIPAL_INVESTIGATOR

Boston Children's Hospital, Brigham and Women's Hospital

Locations

Boston Children's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

P00005391

Identifier Type: -

Identifier Source: org_study_id