NCT01822769

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

3.3 years

First QC Date

March 28, 2013

Last Update Submit

January 23, 2018

Conditions

Congenital Heart DiseaseHeart Defects, Congenital

Keywords

congenital heart diseaseadult congenital heart diseasecardiac rehabilitationcardiopulmonary rehabilitationexercisecardiopulmonary exercise testingpeak vO2quality of life

Outcome Measures

Primary Outcomes (1)

  • Change in aerobic exercise capacity (peak VO2)

    Baseline to 3 months (primary)

Secondary Outcomes (1)

  • Change in quality of life measurement

    Baseline to 3 months (primary)

Other Outcomes (10)

  • Change in peak cardiac output and its components (SV/HR)

    Baseline to 3 months (primary)

  • Mechanism of change in peak VO2

    Baseline to 3 months (primary)

  • Change in ventilatory efficiency

    Baseline to 3 months (primary)

  • +7 more other outcomes

Study Arms (2)

Cardiopulmonary rehabilitation

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.

Other: Cardiopulmonary rehabilitation

Standard of care

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).

Other: Standard of care

Interventions

Cardiopulmonary rehabilitationOTHER

See Arm Description

Cardiopulmonary rehabilitation
Standard of careOTHER

See Arm Description

Standard of care

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Heart Defects, CongenitalMotor Activity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Alexander Opotowsky

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 28, 2013

First Posted

April 2, 2013

Study Start

April 1, 2013

Primary Completion

August 1, 2016

Study Completion

December 1, 2017

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations

US(1)