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OpenTrials
Completed

NCT Number: NCT01822769

Cardiopulmonary Rehabilitation for Adolescents and Adults With Congenital Heart Disease

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.

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Key information

Conditions

Congenital Heart Disease Behavior Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Motor Activity

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Cardiopulmonary rehabilitation

Other

See Arm Description

Standard of care

Other

See Arm Description

Primary outcomes

  1. Change in aerobic exercise capacity (peak VO2)

    Time frame: Baseline to 3 months (primary)

Secondary outcomes

  1. Change in quality of life measurement

    Time frame: Baseline to 3 months (primary)

Other outcomes

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

    Time frame: Baseline to 3 months (primary)

  2. Mechanism of change in peak VO2

    Time frame: Baseline to 3 months (primary)

    Cardiac output will be assessed and O2 delivery/extraction will be estimated to define mechanisms of improvement in exercise capacity.

  3. Change in ventilatory efficiency

    Time frame: Baseline to 3 months (primary)

  4. Change in strength (dynamometry)

    Time frame: Baseline to 3 months (primary)

  5. Change in pulse wave velocity

    Time frame: Baseline to 3 months

  6. Change in circulating biomarkers

    Time frame: Baseline to 3 months (primary)

  7. Change in markers of pulse reflection

    Time frame: Baseline to 3 months

  8. Incidence of arrhythmia and other adverse events during cardiopulmonary rehabilitation

    Time frame: Baseline to 3 months

  9. Change in physical activity

    Time frame: Baseline to 3 months

    Survey and accelerometry

  10. Change in markers of ventricular function

    Time frame: Baseline to 3 months

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2017
First posted
Apr 2, 2013
Registry last updated
Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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