Clinical trial NCT03208751: Sport as Therapy: a 6-months Lifestyle-Intervention for Patients With Coronary Artery Disease and/or Diabetes
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Exercise Training
Coronary Artery Disease
Diabetes Mellitus, Type 2
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A single-arm intervention with exercise training as secondary prevention strategy
Primary purpose: PREVENTION

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.

Eligibility 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)

Primary outcomes:
measure: Change in VO2peak in ml/kg/min
timeFrame: 6 months
Secondary outcomes:
measure: Change in HbA1c for patients with diabetes
timeFrame: 6 months
measure: Change in hsCRP
timeFrame: 6 months
measure: Change in E/e'
timeFrame: 6 months
measure: Change in quality of life measured by SF-36
timeFrame: 6 months
measure: Change in insulin IU
timeFrame: 6 months
measure: Change in HDL- and LDL- cholesterol as well as triglycerides
timeFrame: 6 months
measure: Change in Adiponectin
timeFrame: 6 months
measure: Change in Watts at anaerobic threshold VAT
timeFrame: 6 months
measure: Change in Watts at anaerobic threshold RCP
timeFrame: 6 months
measure: Change in max. Watts
timeFrame: 6 months
measure: Change in max. Watts/kg bodyweight
timeFrame: 6 months
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar/ Technische Universitaet Muenchen
Study officials:
affiliation: Technical University Munic
name: Martin Halle, Prof.
role: STUDY_DIRECTOR
References: