- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03463486
Current Outpatient Cardiac Rehabilitation in Austria
April 22, 2022 updated by: Prof. Josef Niebauer M.D., Ph.D., MBA, Paracelsus Medical University
Outpatient Cardiac Rehabilitation in Austria
Aim of this study is to give evidence to outpatient cardiac rehabilitation in Austria.
The database created in this context is supposed to pave the way as instrument to document and comprehend quality of outpatient cardiac rehabilitation in Austria as a key for quality management.
Analyses of the created database should be made on a regular basis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
8000
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
-
-
-
Salzburg, Austria, 5020
- Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University
-
-
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
12 years to 99 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who qualified for an outpatient cardiac rehabilitation
Description
Inclusion Criteria:
Any patient who meets inclusion criteria for outpatient cardiac rehabilitation in Austria -
Exclusion Criteria:
- Medical conditions which prevent patients from complying with the exercise program
- Acute infections
- Hypertrophic cardiomyopathy
- Pulmonary artery embolism or phlebothrombosis within the previous 6 months
- Unstable angina pectoris
- Heart failure (NYHA IV)
- Hemodynamically unstable arrhythmia
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in Physical Work Capacity (PWC) in Phase II rehabilitation
Time Frame: 6 weeks
|
PWC is measured by a graded exercise test on a cycle ergometer at start and end of outpatient cardiac rehabilitation
|
6 weeks
|
|
Change from baseline in Physical Work Capacity (PWC) in Phase III rehabilitation
Time Frame: 1 year
|
PWC is measured by a graded exercise test on a cycle ergometer at start and end of outpatient cardiac rehabilitation
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in Cholesterol in Phase II rehabilitation
Time Frame: 6 weeks
|
Venous blood samples are taken to assess Cholesterol
|
6 weeks
|
|
Change from baseline in Cholesterol in Phase III rehabilitation
Time Frame: 1 year
|
Venous blood samples are taken to assess Cholesterol
|
1 year
|
|
Change from baseline in Triglycerides in Phase II rehabilitation
Time Frame: 6 weeks
|
Venous blood samples are taken to assess Triglycerides
|
6 weeks
|
|
Change from baseline in Triglycerides in Phase III rehabilitation
Time Frame: 1 year
|
Venous blood samples are taken to assess Triglycerides
|
1 year
|
|
Change from baseline in Blood Glucose in Phase II rehabilitation
Time Frame: 6 weeks
|
Venous blood samples are taken to assess blood glucose
|
6 weeks
|
|
Change from baseline in Blood Glucose in Phase III rehabilitation
Time Frame: 1 year
|
Venous blood samples are taken to assess blood glucose
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Prof. Josef Niebauer, MD, PhD, MBA, Institute of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University Salzburg, Austria
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Niebauer J, Hambrecht R, Velich T, Hauer K, Marburger C, Kalberer B, Weiss C, von Hodenberg E, Schlierf G, Schuler G, Zimmermann R, Kubler W. Attenuated progression of coronary artery disease after 6 years of multifactorial risk intervention: role of physical exercise. Circulation. 1997 Oct 21;96(8):2534-41. doi: 10.1161/01.cir.96.8.2534.
- Adams V, Reich B, Uhlemann M, Niebauer J. Molecular effects of exercise training in patients with cardiovascular disease: focus on skeletal muscle, endothelium, and myocardium. Am J Physiol Heart Circ Physiol. 2017 Jul 1;313(1):H72-H88. doi: 10.1152/ajpheart.00470.2016. Epub 2017 May 5.
- Niebauer J, Mayr K, Harpf H, Hofmann P, Muller E, Wonisch M, Pokan R, Benzer W. Long-term effects of outpatient cardiac rehabilitation in Austria: a nationwide registry. Wien Klin Wochenschr. 2014 Mar;126(5-6):148-55. doi: 10.1007/s00508-014-0527-3. Epub 2014 Mar 11.
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)
January 1, 2005
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
December 1, 2021
Study Registration Dates
First Submitted
October 17, 2017
First Submitted That Met QC Criteria
March 6, 2018
First Posted (Actual)
March 13, 2018
Study Record Updates
Last Update Posted (Actual)
April 25, 2022
Last Update Submitted That Met QC Criteria
April 22, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UISM-11
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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