Cardiac Rehabilitation in Austrian Outpatient Facilities.

Cardiovascular Diseases Clinical Trial

— EvOCaReAustria  

Official title:

Evaluation of Outpatient Cardiac Rehabilitation in Austrian Outpatient Facilities.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05432921
• Other study ID #: UISM-15
• Status: Active, not recruiting
• Start date: September 27, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Paracelsus Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cardiac rehabilitation (CR) is a key component of the treatment of cardiac diseases. The Austrian outpatient CR model is unique, as it provides patients with an extended professionally supervised, multidisciplinary program of 4-6 weeks of phase II (OUT-II) and 12 months of phase III (OUT-III) CR CR including a "refresher". The aim of this retrospective analysis is to pool data from preferably all Austrian outpatient rehabilitation facilities and to analyze the efficacy of the Austrian cardiac rehabilitation model with a special focus on phase III. Data of patients who completed OUT-III between 1.1.2019 and 01.07.2022 will be analyzed. All patients undergo assessment of anthropometry, resting blood pressure, lipid profile, fasting blood glucose, exercise capacity, quality of life, anxiety and depression at the beginning (T1), in the middle (T2) and end of CR (T3).

Description:

Cardiac rehabilitation (CR) is a multidisciplinary therapeutic intervention aimed at regaining and maintaining long-term professional and social integration. Specialist societies classify cardiac rehabilitation with the highest recommendation level (Class I). The focal points of therapy in cardiac rehabilitation include health education, optimization of risk factors through psycho-social counseling and structured physical training.

The four-tier Austrian model of cardiac rehabilitation consists of phase I, which takes place in the acute care hospital directly after a cardiac event or intervention/surgery. Phase II ideally follows immediately and lasts 3-4 weeks as an inpatient or alternatively 6 weeks as an outpatient CR. In the subsequent phase III patients ideally transfer knowledge and skills gained during rehabilitation into their daily lives. Supervised outpatient training is carried out once or twice a week for 6 months and takes part in psycho-social and physical health training courses. This is followed by a 3-6 months lasting "home phase" in which patients to follow the agreed-on lifestyle changes on their own, while documenting successes and problems. After this home phase, the Austrian model provides a "refresher" consisting of two guided outpatient training sessions as well as psychological consultation and a medical examination including a stress test. The refresher must be completed within a maximum of four weeks and is a unique feature of the Austrian model, aiming to achieve sustainable lifestyle modification. The patient-financed and life-long phase IV begins no later than 18 months after the start of phase II. Its aim is to achieve an improvement in the prognosis through lifelong, autonomous and self-responsible behavior and long-term prevention.

The aim of this retrospective analysis is to pool data from preferably all Austrian outpatient rehabilitation facilities and to analyze the efficacy of the Austrian cardiac rehabilitation model with a special focus on phase III.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2023
• Est. primary completion date: August 1, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Any patient who meets inclusion criteria for outpatient cardiac rehabilitation in Austria

Exclusion Criteria:

• Patients are excluded, if they don't meet the inclusion criteria.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• Lifestyle modification
50min of endurance combined with 50min of strength training; 1-2 sessions/week for 6 month, follow up after 3-6month

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Josef Niebauer M.D., Ph.D., MBA

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. — View Citation

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 — View Citation

Reich B, Benzer W, Harpf H, Hofmann P, Mayr K, Ocenasek H, Podolsky A, Pokan R, Porodko M, Puelacher C, Sareban M, Traninger H, Ziegelmeyer W, Niebauer J. Efficacy of extended, comprehensive outpatient cardiac rehabilitation on cardiovascular risk factors — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in physical work capacity (PWC) in phase III rehabilitation	PWC is measured during a graded exercise test on a cycle ergometer at begin and end of outpatient cardiac rehabilitation	12months
Primary	Change from baseline in physical work capacity (PWC) within the first 6month of Phase III	PWC is measured during a graded exercise test on a cycle ergometer at begin and midtime of outpatient cardiac rehabilitation	3-6months
Secondary	Change from baseline in LDL-Cholesterol in Phase III rehabilitation	Venous blood samples are drawn to assess Cholesterol at the start and end of Phase III rehabilitation	12months
Secondary	Change from baseline in Triglycerides in Phase III rehabilitation	Venous blood samples are drawn to assess Triglycerides at the begin and end of Phase III	12months
Secondary	Change from baseline in Glucose in Phase III rehabilitation	Venous blood samples are drawn to assess Triglycerides at the begin and end of Phase III	12months

External Links

•   Institute of Sports Medicine, Prevention and Rehabilitation
•   Paracelsus Medical University