An interventional study of Exercise training in Exercise Training, Coronary Artery Disease and Diabetes Mellitus, Type 2, sponsored by Technical University of Munich. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-07-19.
Sponsored by Technical University of Munich · Not applicable, Interventional, and Prevention
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.
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's planned enrollment of 500 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Technical University of Munich is the lead sponsor of 315 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
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.
Change in VO2peak in ml/kg/min
Exercise capacity measured by cardiorespiratory exercise testing from start to the end of 6 months training intervention
Time frame: 6 months
Change in HbA1c for patients with diabetes
Glycated hemoglobin \>5,7 corresponds to glucose intolerance, \> 6,5 is diagnosed diabetes mellitus
Time frame: 6 months
Change in hsCRP
high sensitivity C-reactive protein, as an inflammation marker and risk marker for further CAD events
Time frame: 6 months
Change in E/e'
E/e' is an echocardiographic marker for diastolic function, an E/e' \< 8 is considered as normal
Time frame: 6 months
Change in quality of life measured by SF-36
The short form (SF-36) is a validated questionnaire for quality of life, the physical and psychical sum scale are measured
Time frame: 6 months
Change in insulin IU
Insulin dosage is measured in IE (international units)
Time frame: 6 months
Change in HDL- and LDL- cholesterol as well as triglycerides
all measured in mg/dl
Time frame: 6 months
Change in Adiponectin
Adiponectin is an adipokine which is released by fat tissue
Time frame: 6 months
Change in Watts at anaerobic threshold VAT
VAT= ventilatory anaerobic threshold, measured by cardiopulmonary exercise testing
Time frame: 6 months
Change in Watts at anaerobic threshold RCP
RCP= respiratory compensation point, measured by cardiopulmonary exercise testing
Time frame: 6 months
Change in max. Watts
On bicycle ergometry, Watts are measured
Time frame: 6 months
Change in max. Watts/kg bodyweight
max. Watts indexed b body weight
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Technical University of Munich