Trial document





This trial has been registered retrospectively.
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  DRKS00012341

Trial Description

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Title

Life-style intervention in patients with coronary artery disease and/or diabetes mellitus

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Trial Acronym

Sport als Therapie

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Regular exercise training in patients with coronary artery disease (CAD) has positive effects on known cardiovascular risk factors such as hypertension, diabetes mellitus type 2, hyperlipidemia and abdominal obesity. Regular aerobic exercise training improves exercise capacity: for every improvement in VO2peak of 1ml/kg/min, a reduction in cardiovascular mortality of 8-10% is expected. This is why regular exercise training is an important pillar in secondary prevention. The program "Sport as Therapy" includes exercise training, when needed nutritional counseling as well as motivational training in a patient cohort with CAD and/or diabetes mellitus. Primary endpoint is the change in exercise capacity measured by cardiorespiratory exercise testing. Further endpoints include change in glycated Hemoglobin (HbA1c), abdominal circumference, lipid values, blood pressure as well as other parameters including quality of life.

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Organizational Data

  •   DRKS00012341
  •   2017/05/09
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  •   no
  •   Approved
  •   5132/11, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

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Health Condition or Problem studied

  •   I25.1 -  Atherosclerotic heart disease
  •   E11 -  Type 2 diabetes mellitus
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Interventions/Observational Groups

  •   Training intervention is divided into 3 Phases:
    Phase 1 (six weeks): Supervised moderate intensity training three times/week at intensities of about 60% VO2peak, duration from 20 min (week 1+2) to 40 min (week 5+6).
    Phase 2 (six weeks): Supervised higher intensity interval exercise twice a week progresses throughout Phase II to heart rates corresponding to 80% VO2peak for four three-minutes intervals separated by recovery intervals of 3 min at heart rates corresponding to 60% VO2peak, plus at least one home-based moderate intensity training session per week. Furthermore, resistance training of 20 min duration at an intensity measured by Borg-Scale (11-13) is performed.
    Phase 3 (12 weeks): Supervised higher intensity interval training once a week at heart rates corresponding to 85% VO2peak for four intervals of four minutes, separated by recovery intervals of three minutes at 60% and two to four home-based moderate intensity training sessions per week. Resistance training as described in phase 2.
    Nutritional counseling is recomended to all diabetics as well as all overweight patients. It is based on the principle of energy density and is performed on individual basis.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Change in exercise capacity measured as VO2peak (ml/min/kg) between the time just before beginning and after 6 months of training intervention. Measurement is done by cardiorespiratory exercise testing.

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Secondary Outcome

Change of following parameters between the time just before beginning and after 6 months of intervention: HbA1c, LDL-cholesterol, HDL-cholesterol, HOMA-score, adiponectin, proBNP, diastolic functional parameters (E/e'), maximal and submaximal exercise parameters (max. Watts, Watt/kg, watts and VO2 at - aerobic and anaerobic -
thresholds VAT and at RCP).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/01/01
  •   500
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

Coronary artery disease and/or diabetes mellitus

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Exclusion Criteria

physical and psychiatric diseases in which physical exercise is not feasible. Patients requiring nursing care.

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Addresses

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    • Techniker Krankenkasse
    • Ms.  Dr.  Nicole  Knaack 
    • Bramfelder Str. 140
    • 22305  Hamburg
    • Germany
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    • Klinikum rechts der Isar der TU München
    • Mr.  Univ.-Prof.   Martin  Halle  
    • Ismaninger Str. 22
    • 81675  München
    • Germany
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    • Klinikum rechts der Isar
    • Ms.  Dr.  Alessandra  Boscheri 
    • Ismaninger Str. 22
    • 81675  München
    • Germany
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Sources of Monetary or Material Support

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    • Techniker Krankenkasse
    • Ms.  Dr.  Nicole  Knaack 
    • Bramfelder Str. 140
    • 22305  Hamburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.