Sport as Therapy: a 6-months Lifestyle-Intervention for Patients With Coronary Artery Disease and/or Diabetes
Primary Purpose
Exercise Training, Coronary Artery Disease, Diabetes Mellitus, Type 2
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Exercise training
Sponsored by
About this trial
This is an interventional prevention trial for Exercise Training
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)
Sites / Locations
- Klinikum rechts der Isar/ Technische Universitaet Muenchen
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Exercise training
Arm Description
All patients were included in the exercise training group
Outcomes
Primary Outcome Measures
Change in VO2peak in ml/kg/min
Exercise capacity measured by cardiorespiratory exercise testing from start to the end of 6 months training intervention
Secondary Outcome Measures
Change in HbA1c for patients with diabetes
Glycated hemoglobin >5,7 corresponds to glucose intolerance, > 6,5 is diagnosed diabetes mellitus
Change in hsCRP
high sensitivity C-reactive protein, as an inflammation marker and risk marker for further CAD events
Change in E/e'
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
The short form (SF-36) is a validated questionnaire for quality of life, the physical and psychical sum scale are measured
Change in insulin IU
Insulin dosage is measured in IE (international units)
Change in HDL- and LDL- cholesterol as well as triglycerides
all measured in mg/dl
Change in Adiponectin
Adiponectin is an adipokine which is released by fat tissue
Change in Watts at anaerobic threshold VAT
VAT= ventilatory anaerobic threshold, measured by cardiopulmonary exercise testing
Change in Watts at anaerobic threshold RCP
RCP= respiratory compensation point, measured by cardiopulmonary exercise testing
Change in max. Watts
On bicycle ergometry, Watts are measured
Change in max. Watts/kg bodyweight
max. Watts indexed b body weight
Full Information
NCT ID
NCT03208751
First Posted
May 26, 2017
Last Updated
July 18, 2019
Sponsor
Technical University of Munich
1. Study Identification
Unique Protocol Identification Number
NCT03208751
Brief Title
Sport as Therapy: a 6-months Lifestyle-Intervention for Patients With Coronary Artery Disease and/or Diabetes
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2011 (Actual)
Primary Completion Date
August 1, 2019 (Anticipated)
Study Completion Date
January 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technical University of Munich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Training, Coronary Artery Disease, Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A single-arm intervention with exercise training as secondary prevention strategy
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise training
Arm Type
Other
Arm Description
All patients were included in the exercise training group
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in VO2peak in ml/kg/min
Description
Exercise capacity measured by cardiorespiratory exercise testing from start to the end of 6 months training intervention
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in HbA1c for patients with diabetes
Description
Glycated hemoglobin >5,7 corresponds to glucose intolerance, > 6,5 is diagnosed diabetes mellitus
Time Frame
6 months
Title
Change in hsCRP
Description
high sensitivity C-reactive protein, as an inflammation marker and risk marker for further CAD events
Time Frame
6 months
Title
Change in E/e'
Description
E/e' is an echocardiographic marker for diastolic function, an E/e' < 8 is considered as normal
Time Frame
6 months
Title
Change in quality of life measured by SF-36
Description
The short form (SF-36) is a validated questionnaire for quality of life, the physical and psychical sum scale are measured
Time Frame
6 months
Title
Change in insulin IU
Description
Insulin dosage is measured in IE (international units)
Time Frame
6 months
Title
Change in HDL- and LDL- cholesterol as well as triglycerides
Description
all measured in mg/dl
Time Frame
6 months
Title
Change in Adiponectin
Description
Adiponectin is an adipokine which is released by fat tissue
Time Frame
6 months
Title
Change in Watts at anaerobic threshold VAT
Description
VAT= ventilatory anaerobic threshold, measured by cardiopulmonary exercise testing
Time Frame
6 months
Title
Change in Watts at anaerobic threshold RCP
Description
RCP= respiratory compensation point, measured by cardiopulmonary exercise testing
Time Frame
6 months
Title
Change in max. Watts
Description
On bicycle ergometry, Watts are measured
Time Frame
6 months
Title
Change in max. Watts/kg bodyweight
Description
max. Watts indexed b body weight
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Halle, Prof.
Organizational Affiliation
Technical University Munic
Official's Role
Study Director
Facility Information:
Facility Name
Klinikum rechts der Isar/ Technische Universitaet Muenchen
City
Munich
ZIP/Postal Code
81675
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sport as Therapy: a 6-months Lifestyle-Intervention for Patients With Coronary Artery Disease and/or Diabetes
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