Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease

Not Applicable

Completed

• Conditions: Heart Defects, Congenital; Congenital Heart Disease
• Interventions: Other: Cardiopulmonary rehabilitation; Other: Standard of care

• Registration Number: NCT01822769
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-28
• Study First Submitted QC: 2013-03-28
• Study Start: 2013-04
• Study First Posted: 2013-04-02
• Primary Completion: 2016-08
• Study Completion: 2017-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardiopulmonary rehabilitation	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.
Standard of care	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).

Primary Outcome Measures

Name	Time	Method
Change in aerobic exercise capacity (peak VO2)	Baseline to 3 months (primary)

Secondary Outcome Measures

Name	Time	Method
Change in quality of life measurement	Baseline to 3 months (primary)

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States