CClinicalTrials.gg
Status unknownNCT05432921EvOCaReAustriaUpdated Apr 13, 2023

Cardiac Rehabilitation in Austrian Outpatient Facilities.

An observational study in Cardiovascular Diseases, sponsored by Prof. Josef Niebauer M.D., Ph.D., MBA. Status unknown at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-13.

Sponsored by Prof. Josef Niebauer M.D., Ph.D., MBA · Observational

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,500
Ages
18 Years and older
Sex
All
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Study 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).

Read the detailed 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.

02

Conditions studied

  • Cardiovascular Diseases

Keywords

  • cardiac rehabilitation
  • exercise training
  • lifestyle modification
  • coronary-artery-disease
  • myocardial infarction
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In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's planned enrollment of 1,500 is above the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

This is the only study on the registry with Prof. Josef Niebauer M.D., Ph.D., MBA as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients that completed in- our outpatient phase II and phase III out-patient cardiac rehabilitation. Diagnoses that qualify for cardiac rehabilitation paid by health insurances comprise acute coronary syndrome; percutaneous coronary intervention; stable coronary heart disease; aortocoronary bypass surgery; other surgeries of the heart and the big vessels; heart and lung transplantation; chronic heart failure; pulmonary hypertension; peripheral artery occlusive disease; prevention in motivated high risk patients; electro-physiological intervention; implantation of a cardiac pacemaker or a defibrillator; haemodynamically stable arrhythmia; sustained ventricular tachycardia or cardiac arrest.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Patient registry
No

Interventions

  • BehavioralLifestyle modification

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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 12months

  2. 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

    Time frame: 3-6months

Secondary outcomes

  1. 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

    Time frame: 12months

  2. 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

    Time frame: 12months

  3. 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

    Time frame: 12months

07

Study locations

1 site
  • Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University
    Salzburg, 5020, Austria
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References and documents

Publications

  • 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. PubMed 28476924 ↗
  • 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: A nationwide registry. Eur J Prev Cardiol. 2020 Jul;27(10):1026-1033. doi: 10.1177/2047487319898958. Epub 2020 Jan 14. PubMed 31937125 ↗
  • 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. PubMed 24615677 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05432921
Lead sponsor
Prof. Josef Niebauer M.D., Ph.D., MBA
Responsible party
Prof. Josef Niebauer M.D., Ph.D., MBA (Head of Institute, Paracelsus Medical University) — Sponsor-investigator
First posted
Jun 27, 2022
Start date
Sep 27, 2022
Primary completion
Aug 1, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Apr 13, 2023

Study contacts

Josef Niebauer, MD, PhD, MBA
study director · Paracelsus Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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