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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03208751
• Other study ID #: 5132/11
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2011
• Est. completion date: January 1, 2020

Study information

• Verified date: July 2019
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: January 1, 2020
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Exercise Training
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar/ Technische Universitaet Muenchen	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in VO2peak in ml/kg/min	Exercise capacity measured by cardiorespiratory exercise testing from start to the end of 6 months training intervention	6 months
Secondary	Change in HbA1c for patients with diabetes	Glycated hemoglobin >5,7 corresponds to glucose intolerance, > 6,5 is diagnosed diabetes mellitus	6 months
Secondary	Change in hsCRP	high sensitivity C-reactive protein, as an inflammation marker and risk marker for further CAD events	6 months
Secondary	Change in E/e'	E/e' is an echocardiographic marker for diastolic function, an E/e' < 8 is considered as normal	6 months
Secondary	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	6 months
Secondary	Change in insulin IU	Insulin dosage is measured in IE (international units)	6 months
Secondary	Change in HDL- and LDL- cholesterol as well as triglycerides	all measured in mg/dl	6 months
Secondary	Change in Adiponectin	Adiponectin is an adipokine which is released by fat tissue	6 months
Secondary	Change in Watts at anaerobic threshold VAT	VAT= ventilatory anaerobic threshold, measured by cardiopulmonary exercise testing	6 months
Secondary	Change in Watts at anaerobic threshold RCP	RCP= respiratory compensation point, measured by cardiopulmonary exercise testing	6 months
Secondary	Change in max. Watts	On bicycle ergometry, Watts are measured	6 months
Secondary	Change in max. Watts/kg bodyweight	max. Watts indexed b body weight	6 months