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Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease

NCT01822769 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2018-01-25

No results posted yet for this study

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

Interventions

OTHER

Cardiopulmonary rehabilitation

See Arm Description

OTHER

Standard of care

See Arm Description

Sponsors & Collaborators

Principal Investigators

  • Alexander Opotowsky · Boston Children's Hospital, Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2016-08-31
Completion
2017-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01822769 on ClinicalTrials.gov