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

NCT ID: NCT03208751

Last Updated: 2019-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-01
• Study Completion Date: 2020-01-01

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.

Conditions

Exercise Training; Coronary Artery Disease; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Exercise training

All patients were included in the exercise training group

Group Type: OTHER

Exercise training

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey W Christle

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Halle, Prof.

Role: STUDY_DIRECTOR

Technical University Munic

Locations

Klinikum rechts der Isar/ Technische Universitaet Muenchen

Munich, , Germany

Countries

Germany

Other Identifiers

5132/11

Identifier Type: -

Identifier Source: org_study_id