Coronary Artery Disease, Diabetes Mellitus, Type 2, Exercise Training
Conditions
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.
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.
Interventions
BEHAVIORALExercise 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.
Sponsors
Technical University of Munich
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
A single-arm intervention with exercise training as secondary prevention strategy
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in VO2peak in ml/kg/min | 6 months | Exercise capacity measured by cardiorespiratory exercise testing from start to the end of 6 months training intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in hsCRP | 6 months | high sensitivity C-reactive protein, as an inflammation marker and risk marker for further CAD events |
| Change in E/e' | 6 months | E/e' is an echocardiographic marker for diastolic function, an E/e' \< 8 is considered as normal |
| Change in quality of life measured by SF-36 | 6 months | The short form (SF-36) is a validated questionnaire for quality of life, the physical and psychical sum scale are measured |
| Change in insulin IU | 6 months | Insulin dosage is measured in IE (international units) |
| Change in HDL- and LDL- cholesterol as well as triglycerides | 6 months | all measured in mg/dl |
| Change in HbA1c for patients with diabetes | 6 months | Glycated hemoglobin \>5,7 corresponds to glucose intolerance, \> 6,5 is diagnosed diabetes mellitus |
| Change in Watts at anaerobic threshold VAT | 6 months | VAT= ventilatory anaerobic threshold, measured by cardiopulmonary exercise testing |
| Change in Watts at anaerobic threshold RCP | 6 months | RCP= respiratory compensation point, measured by cardiopulmonary exercise testing |
| Change in max. Watts | 6 months | On bicycle ergometry, Watts are measured |
| Change in max. Watts/kg bodyweight | 6 months | max. Watts indexed b body weight |
| Change in Adiponectin | 6 months | Adiponectin is an adipokine which is released by fat tissue |
Countries
Germany
Outcome results
None listed