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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date April 2022
Source Paracelsus Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Physical activity
50min of endurance training combined with 50min of calisthenics; 1-3x/wekk; 6weeks up to 1year

Locations

Country Name City State
Austria Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University Salzburg

Sponsors (1)

Lead Sponsor Collaborator
Paracelsus Medical University

Country where clinical trial is conducted

Austria, 

References & Publications (3)

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

Outcome

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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