- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03208751
Sport as Therapy: a 6-months Lifestyle-Intervention for Patients With Coronary Artery Disease and/or Diabetes
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 Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Munich, Germany, 81675
- Klinikum rechts der Isar/ Technische Universitaet Muenchen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Investigators
- Study Director: Martin Halle, Prof., Technical University Munic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5132/11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Coronary Artery Disease
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
China National Center for Cardiovascular DiseasesRecruitingLeft Main Coronary Artery DiseaseChina
Clinical Trials on Exercise training
-
University of British ColumbiaMichael Smith Foundation for Health ResearchCompleted
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloCompleted
-
Universidade Norte do ParanáCompleted
-
University of Colorado, DenverVA Eastern Colorado Health Care SystemCompletedHealthy | Overweight | Type 2 Diabetes Mellitus | Cardiovascular Risk FactorUnited States
-
National Taiwan University HospitalCompletedAtrial FibrillationTaiwan
-
Universita di VeronaRecruiting
-
Hacettepe UniversityCompleted
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
University of LeipzigCompletedImpact of Intensive Exercise Training on Coronary Collateral Circulation in Patients With Stable CADStable Coronary Artery DiseaseGermany
-
Helse Stavanger HFStavanger Health ResearchCompletedVentricular TachycardiaNorway