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Cardiovascular DiseasesEvOCaReAustriaNCT05432921

Cardiac Rehabilitation in Austrian Outpatient Facilities.

An observational study of Cardiovascular Diseases, run by Prof. Josef Niebauer M.D., Ph.D., MBA at 1 site in Austria.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiovascular Diseases
What is being tested?
Lifestyle modification
How many people
1,500 participants
Where
1 siteAustria
Study dates
27 Sep 2022to 31 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Austria1 site

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

    Salzburg, 5020

Other trials in Austria

About this study

Official title: Evaluation of Outpatient Cardiac Rehabilitation in Austrian Outpatient Facilities.

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.

Being tested
Lifestyle modification
Keywords
cardiac rehabilitation, exercise training, lifestyle modification, coronary-artery-disease, myocardial infarction
Medical subject headings
Cardiovascular Diseases, Coronary Artery Disease, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle modificationBehavioural

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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

    Measured: 3-6months

Secondary outcomes (3)

  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

    Measured: 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

    Measured: 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

    Measured: 12months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2022
  2. Study start27 Sep 2022
  3. Primary completion1 Aug 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05432921
Sponsor's protocol ID
UISM-15
Acronym
EvOCaReAustria
Status last verified
Apr 2023
First submitted
21 Jun 2022
Last updated
13 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases, run by Prof. Josef Niebauer M.D., Ph.D., MBA at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in physical work capacity (PWC) in phase III rehabilitation (time frame: 12months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05432921, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.

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