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NCT01540006 Clinical Trial

Outpatient Cardiac Rehabilitation in Austria

Heart Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01540006
Other study ID # UISM-6
Secondary ID
Status Completed
Phase N/A
First received February 22, 2012
Last updated October 17, 2017
Start date January 2009
Est. completion date May 2014

Study information
Verified date October 2017
Source Paracelsus Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this prospective trial is the manifestation of guidelines developed for outpatient cardiac rehabilitation in Austria.

The evaluation of prospective and retrospective data is supposed to give evidence on morbidity and/or mortality advantages compared to patients not participating in cardiac rehabilitation programs.

The database created in this context is supposed to pave the way as instrument to document and comprehend quality and cost effectiveness of outpatient cardiac rehabilitation in Austria as a key for quality management.

Recruitment information / eligibility
Status Completed
Enrollment 1200
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- heart disease

Exclusion Criteria:

- participation in another study within the previous 6 months

- 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

Other:
• Physical activity
50min of endurance training combined with 45min of calisthenics; 1-3x/week; 6-24 weeks

Locations
Country Name City State
Austria Department 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)

Flynn KE, Piña IL, Whellan DJ, Lin L, Blumenthal JA, Ellis SJ, Fine LJ, Howlett JG, Keteyian SJ, Kitzman DW, Kraus WE, Miller NH, Schulman KA, Spertus JA, O'Connor CM, Weinfurt KP; HF-ACTION Investigators. Effects of exercise training on health status in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1451-9. doi: 10.1001/jama.2009.457. Erratum in: JAMA. 2009 Dec 2;302(21):2322. — 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

O'Connor CM, Whellan DJ, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Miller NH, Fleg JL, Schulman KA, McKelvie RS, Zannad F, Piña IL; HF-ACTION Investigators. Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1439-50. doi: 10.1001/jama.2009.454. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Physical work capacity (PWC) PWC is measuered by gradded exercise test on cycling ergometer before and after rehabilitation. 6 weeks
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