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

Not Applicable

• Conditions: Diabetes Mellitus, Type 2; Exercise Training; Coronary Artery Disease
• Interventions: Behavioral: Exercise training

• Registration Number: NCT03208751
• Lead Sponsor: Technical University of Munich

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.

Study Timeline

• Study Start: 2011-04-01
• Study First Submitted: 2017-05-26
• Study First Submitted QC: 2017-07-02
• Study First Posted: 2017-07-06
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-18
• Last Update Posted: 2019-07-19
• Primary Completion: 2019-08-01
• Study Completion: 2020-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise training	Exercise training	All patients were included in the exercise training group

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change in insulin IU	6 months	Insulin dosage is measured in IE (international units)
Change in Adiponectin	6 months	Adiponectin is an adipokine which is released by fat tissue
Change in max. Watts/kg bodyweight	6 months	max. Watts indexed b body weight
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 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 Watts at anaerobic threshold RCP	6 months	RCP= respiratory compensation point, measured by cardiopulmonary exercise testing
Change in hsCRP	6 months	high sensitivity C-reactive protein, as an inflammation marker and risk marker for further CAD events
Change in HDL- and LDL- cholesterol as well as triglycerides	6 months	all measured in mg/dl
Change in Watts at anaerobic threshold VAT	6 months	VAT= ventilatory anaerobic threshold, measured by cardiopulmonary exercise testing
Change in max. Watts	6 months	On bicycle ergometry, Watts are measured

Trial Locations

Locations (1)

Klinikum rechts der Isar/ Technische Universitaet Muenchen; 🇩🇪 Munich, Germany