Cardiovascular Diseases Clinical Trial
Official title:
Outpatient Cardiac Rehabilitation in Austria
NCT number | NCT03463486 |
Other study ID # | UISM-11 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2005 |
Est. completion date | December 2021 |
Verified date | April 2022 |
Source | Paracelsus Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 8000 |
Est. completion date | December 2021 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | 12 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Austria | Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University | Salzburg |
Lead Sponsor | Collaborator |
---|---|
Paracelsus Medical University |
Austria,
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. Review. — View Citation
Niebauer J, Hambrecht R, Velich T, Hauer K, Marburger C, Kälberer B, Weiss C, von Hodenberg E, Schlierf G, Schuler G, Zimmermann R, Kübler 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. — View Citation
Niebauer J, Mayr K, Harpf H, Hofmann P, Müller 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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in Physical Work Capacity (PWC) in Phase II rehabilitation | PWC is measured by a graded exercise test on a cycle ergometer at start and end of outpatient cardiac rehabilitation | 6 weeks | |
Primary | Change from baseline in Physical Work Capacity (PWC) in Phase III rehabilitation | PWC is measured by a graded exercise test on a cycle ergometer at start and end of outpatient cardiac rehabilitation | 1 year | |
Secondary | Change from baseline in Cholesterol in Phase II rehabilitation | Venous blood samples are taken to assess Cholesterol | 6 weeks | |
Secondary | Change from baseline in Cholesterol in Phase III rehabilitation | Venous blood samples are taken to assess Cholesterol | 1 year | |
Secondary | Change from baseline in Triglycerides in Phase II rehabilitation | Venous blood samples are taken to assess Triglycerides | 6 weeks | |
Secondary | Change from baseline in Triglycerides in Phase III rehabilitation | Venous blood samples are taken to assess Triglycerides | 1 year | |
Secondary | Change from baseline in Blood Glucose in Phase II rehabilitation | Venous blood samples are taken to assess blood glucose | 6 weeks | |
Secondary | Change from baseline in Blood Glucose in Phase III rehabilitation | Venous blood samples are taken to assess blood glucose | 1 year |
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