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Sport as Therapy: a 6-months Lifestyle-Intervention for Patients With Coronary Artery Disease and/or Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03208751
Recruitment Status : Active, not recruiting
First Posted : July 6, 2017
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Jeffrey W Christle, Technische Universität München

Brief Summary:
Regular exercise training has shown to improve exercise capacity in patients with cardiovascular disease. The feasibility and transferability of exercise training in a community based cardiovascular rehabilitation setting is currently less well investigated. The objective of this study is to translate regular exercise training into a community based setting. A 6 months training intervention program with lifestyle counseling is performed, with both supervised training in rehabilitation centres as well as home based training. The aim of the project is to implement this program for a wider patient population and to improve exercise capacity, diastolic function as well as cardiometabolic parameters.

Condition or disease Intervention/treatment Phase
Exercise Training Coronary Artery Disease Diabetes Mellitus, Type 2 Behavioral: Exercise training Not Applicable

Detailed Description:
From 2011, patients insured at "Techniker" health insurance company with diagnosed coronary heart disease, heart failure and/or diabetes mellitus are being included in a 6-months training program. Training is performed 3 times weekly for 6 weeks, then twice weekly for another 6 weeks, while patients are asked to do home based training. The last phase of 12 weeks, supervised training is only once/week. Patients are asked to perform exercise training 3-5 times weekly. At the beginning as well as after 3 and 6 months, patients present for medical check-up with cardiorespiratory exercise testing from which training instructions are drawn. Training-intensity begins with moderate continuous training and switches to higher intensity interval training after 6 weeks. Resistance training starts after 6 weeks and is performed within the supervised training. All patients were offered an individual nutritional counseling.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: A single-arm intervention with exercise training as secondary prevention strategy
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A 6-months Lifestyle Intervention With Interval and Resistance Exercise in Patients With Coronary Artery Disease and Diabetes Mellitus in a Community Based Setting
Actual Study Start Date : April 1, 2011
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Exercise training
All patients were included in the exercise training group
Behavioral: Exercise training

Exercise intervention was divided into 3 phases:

Phase 1: 6 weeks of moderate continuous training (MCT) 20 to 40 minutes at intensity of 60% of VO2peak, 3 times/week Phase 2: 6 weeks of moderate intensity interval training (MIIT) 30-40 min, intensity 60 to 80% of VO2peak, twice weekly plus at least once weekly MCT home based training Phase 3 (after performing new exercise testing to adapt training intensities): 12 weeks of MIIT 40 min once/week, intensity 60-80/85% of VO2peak, plus at least twice weekly home based MCT. From phase 2, supervised sessions included resistance training of at least 3 muscle groups, 3x15 repetitions at moderate intensity (Borg 12-14).

Nutritional counseling is offered up to 4 times in 6 months on an individual basis.





Primary Outcome Measures :
  1. Change in VO2peak in ml/kg/min [ Time Frame: 6 months ]
    Exercise capacity measured by cardiorespiratory exercise testing from start to the end of 6 months training intervention


Secondary Outcome Measures :
  1. Change in HbA1c for patients with diabetes [ Time Frame: 6 months ]
    Glycated hemoglobin >5,7 corresponds to glucose intolerance, > 6,5 is diagnosed diabetes mellitus

  2. Change in hsCRP [ Time Frame: 6 months ]
    high sensitivity C-reactive protein, as an inflammation marker and risk marker for further CAD events

  3. Change in E/e' [ Time Frame: 6 months ]
    E/e' is an echocardiographic marker for diastolic function, an E/e' < 8 is considered as normal

  4. Change in quality of life measured by SF-36 [ Time Frame: 6 months ]
    The short form (SF-36) is a validated questionnaire for quality of life, the physical and psychical sum scale are measured

  5. Change in insulin IU [ Time Frame: 6 months ]
    Insulin dosage is measured in IE (international units)

  6. Change in HDL- and LDL- cholesterol as well as triglycerides [ Time Frame: 6 months ]
    all measured in mg/dl

  7. Change in Adiponectin [ Time Frame: 6 months ]
    Adiponectin is an adipokine which is released by fat tissue

  8. Change in Watts at anaerobic threshold VAT [ Time Frame: 6 months ]
    VAT= ventilatory anaerobic threshold, measured by cardiopulmonary exercise testing

  9. Change in Watts at anaerobic threshold RCP [ Time Frame: 6 months ]
    RCP= respiratory compensation point, measured by cardiopulmonary exercise testing

  10. Change in max. Watts [ Time Frame: 6 months ]
    On bicycle ergometry, Watts are measured

  11. Change in max. Watts/kg bodyweight [ Time Frame: 6 months ]
    max. Watts indexed b body weight



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Coronary artery disease and/or diabetes mellitus
  • Heart failure

Exclusion Criteria:

  • all conditions which are not compatible with exercise training:
  • severe orthopedic disorders
  • severe psychiatric disease
  • severe valve insufficiency
  • presence of myocardial ischemia (decision made by cardiologist)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208751


Locations
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Germany
Klinikum rechts der Isar/ Technische Universitaet Muenchen
Munich, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Investigators
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Study Director: Martin Halle, Prof. Technical University Munic
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Responsible Party: Jeffrey W Christle, Principal investigator, Technische Universität München
ClinicalTrials.gov Identifier: NCT03208751    
Other Study ID Numbers: 5132/11
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases