Overview

This trial is active, not recruiting.

Conditions congenital heart disease, heart defects, congenital
Treatments cardiopulmonary rehabilitation, standard of care
Sponsor Children's Hospital Boston
Start date April 2013
End date August 2015
Trial size 60 participants
Trial identifier NCT01822769, P00005391

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
cardiopulmonary rehabilitation
See Arm Description
(Other)
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).
standard of care
See Arm Description

Primary Outcomes

Measure
Change in aerobic exercise capacity (peak VO2)
time frame: Baseline to 3 months (primary)

Secondary Outcomes

Measure
Change in quality of life measurement
time frame: Baseline to 3 months (primary)

Eligibility Criteria

Male or female participants at least 16 years old.

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%

Additional Information

Official title Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease
Principal investigator Alexander Opotowsky
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Children's Hospital Boston.