Clinical Trial: Rehabilitation in Patients With Congenital Heart Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Cardiac Rehabilitation in Patients With Complex Congenital Heart Disease: Improvement of Exercise Intolerance

Brief Summary: Exercise intolerance is a major burden for patients with complex congenital heart disease (CHD), significantly affecting their quality of life. Cardiopulmonary exercise testing provides a reliable tool both for assessing exercise capacity of CHD patients and for risk stratification and is becoming part of the routine clinical assessment of these patients. Exercise has an effect on the muscular, metabolic and circulatory systems. While exercise training has been widely studied in chronic heart failure, its efficacy in adults with CHD remain unknown. The investigators hypothesize that structured exercise training will improve exercise intolerance, in particular peak VO2. The aim of this multicenter, randomized study is to evaluate the impact of structured exercise training on exercise intolerance in patients with complex CHD.

Detailed Summary:

This is a randomized, prospective, multicenter, interventional study.

After study patients have given written consent they will be randomized either in the interventional group with a rehabilitation program or in the control group without rehabilitation program. Patients who are randomized in the control group are allowed to perform the rehabilitation program 12 months after randomisation. Patients in the interventional group will perform structured exercise training on 3 weekdays during a 12-weeks period. Training will be performed by ergometer and low-impact gymnastic and relaxation training.

All study participants have the following investigations at the beginning of the study and after 12 weeks:

  • Cardiopulmonary exercise testing with spirometry
  • 6-minute walk test
  • Blood work: BNP, Creatinine, Sodium, Potassium, Urat, Cholesterol (HDL-L and LDL-L)
  • Validated Heart failure questionnaires (SF-36 and Minnesota Living with heart failure questionnaire, German version for Basel, Zürich and Bern) All tests will be repeated as clinically indicated in a follow-up visit 12 months after baseline

Primary outcome is:

Comparison of peak VO2 at the end of rehabilitation between both groups.

Secondary outcomes are:

  • Comparison of 6-min walk test, VE/VCO2 slope, anaerobic threshold and heart rate and blood pressure response after rehabilitation between both groups
  • Changes of 6-min wa
    Sponsor: University Hospital, Basel, Switzerland

    Current Primary Outcome: peak VO2 [ Time Frame: 12 weeks ]

    Comparison between both groups


    Original Primary Outcome: peak VO2 [ Time Frame: 12 weeks ]

    Comparison between both gropus


    Current Secondary Outcome:

    • 6 minute walk test [ Time Frame: 12 weeks ]
      between both groups and within groups
    • VE/VCO2 [ Time Frame: 12 weeks ]
      Comparison between groups and within groups
    • heart rate response [ Time Frame: 12 weeks ]
      Difference between peak heart rate and resting heart rate Comparison between groups and within groups
    • QoL [ Time Frame: 12 weeks ]
      Comparison between groups and within groups Minnesota Heart failure Score and SF 36
    • BNP [ Time Frame: 12 weeks ]
      Comparison between groups and within groups
    • Adverse events [ Time Frame: 12 weeks ]
      cardiac related adverse events including cardiac death
    • peak VO2 [ Time Frame: 12 months ]
      Comparison between groups and within groups
    • VE/VCO2 [ Time Frame: 12 months ]
      Comparison between groups and within groups
    • Heart rate response [ Time Frame: 12 months ]
      Comparison between groups and within groups
    • 6 minute walk test [ Time Frame: 12 months ]
      Comparison between groups and within groups
    • QoL [ Time Frame: 12 months ]
      Comparison between groups and within groups
    • BNP [ Time Frame: 12 months ]
      Comparison between groups and within groups
    • Cardiac adverse events [ Time Frame: 12 months ]
      Comparison between groups and within groups


    Original Secondary Outcome: Same as current

    Information By: University Hospital, Basel, Switzerland

    Dates:
    Date Received: October 28, 2011
    Date Started: May 2011
    Date Completion: May 2017
    Last Updated: September 12, 2016
    Last Verified: September 2016