Trial record 8 of 3553 for:    Open Studies | "Heart Diseases"

Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Children's Hospital Boston
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01822769
First received: March 28, 2013
Last updated: August 9, 2013
Last verified: August 2013
  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:


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

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 2014
Estimated Primary Completion Date: May 2014 (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

  Eligibility

Ages Eligible for Study:   16 Years and older
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

Contacts
Contact: Lilamarie Moko 617-355-4347 lilamarie.moko@chboston.org
Contact: Alexander Opotowsky 617-355-6508 ext 4 alexander.opotowsky@chboston.org

Locations
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Lilamarie Moko    617-355-4347    lilamarie.moko@chboston.org   
Principal Investigator: Alexander Opotowsky         
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Alexander Opotowsky Boston Children's Hospital, Brigham and Women's Hospital
  More Information

No publications provided

Responsible Party: 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 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
congenital heart disease
adult congenital heart disease
cardiac rehabilitation
cardiopulmonary rehabilitation
exercise
cardiopulmonary exercise testing
peak vO2
quality of life

Additional relevant MeSH terms:
Congenital Abnormalities
Heart Defects, Congenital
Heart Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 31, 2014