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

Technical University of Munich

Status: Unknown

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

Treatments: Behavioral: Exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT03208751

5132/11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 1 patient group

Exercise training

Other group

Description:

All patients were included in the exercise training group

Treatment:

Behavioral: Exercise training