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

July 18, 2019 updated by: Jeffrey W Christle, Technical University of Munich

A 6-months Lifestyle Intervention With Interval and Resistance Exercise in Patients With Coronary Artery Disease and Diabetes Mellitus in a Community Based Setting

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Munich, Germany, 81675
        • Klinikum rechts der Isar/ Technische Universitaet Muenchen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Exercise training
All patients were included in the exercise training group

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in VO2peak in ml/kg/min
Time Frame: 6 months
Exercise capacity measured by cardiorespiratory exercise testing from start to the end of 6 months training intervention
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c for patients with diabetes
Time Frame: 6 months
Glycated hemoglobin >5,7 corresponds to glucose intolerance, > 6,5 is diagnosed diabetes mellitus
6 months
Change in hsCRP
Time Frame: 6 months
high sensitivity C-reactive protein, as an inflammation marker and risk marker for further CAD events
6 months
Change in E/e'
Time Frame: 6 months
E/e' is an echocardiographic marker for diastolic function, an E/e' < 8 is considered as normal
6 months
Change in quality of life measured by SF-36
Time Frame: 6 months
The short form (SF-36) is a validated questionnaire for quality of life, the physical and psychical sum scale are measured
6 months
Change in insulin IU
Time Frame: 6 months
Insulin dosage is measured in IE (international units)
6 months
Change in HDL- and LDL- cholesterol as well as triglycerides
Time Frame: 6 months
all measured in mg/dl
6 months
Change in Adiponectin
Time Frame: 6 months
Adiponectin is an adipokine which is released by fat tissue
6 months
Change in Watts at anaerobic threshold VAT
Time Frame: 6 months
VAT= ventilatory anaerobic threshold, measured by cardiopulmonary exercise testing
6 months
Change in Watts at anaerobic threshold RCP
Time Frame: 6 months
RCP= respiratory compensation point, measured by cardiopulmonary exercise testing
6 months
Change in max. Watts
Time Frame: 6 months
On bicycle ergometry, Watts are measured
6 months
Change in max. Watts/kg bodyweight
Time Frame: 6 months
max. Watts indexed b body weight
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Martin Halle, Prof., Technical University Munic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2011

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

January 1, 2020

Study Registration Dates

First Submitted

May 26, 2017

First Submitted That Met QC Criteria

July 2, 2017

First Posted (Actual)

July 6, 2017

Study Record Updates

Last Update Posted (Actual)

July 19, 2019

Last Update Submitted That Met QC Criteria

July 18, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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