Cardiac Rehabilitation in Austrian Outpatient Facilities. (EvOCaReAustria)

April 11, 2023 updated by: Prof. Josef Niebauer M.D., Ph.D., MBA

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).

Study Overview

Status

Active, not recruiting

Conditions

Cardiovascular Diseases

Intervention / Treatment

Behavioral: Lifestyle modification

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.

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Austria
- - Salzburg, Austria, 5020
    - Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in physical work capacity (PWC) in phase III rehabilitation Time Frame: 12months	PWC is measured during a graded exercise test on a cycle ergometer at begin and end of outpatient cardiac rehabilitation	12months
Change from baseline in physical work capacity (PWC) within the first 6month of Phase III Time Frame: 3-6months	PWC is measured during a graded exercise test on a cycle ergometer at begin and midtime of outpatient cardiac rehabilitation	3-6months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in LDL-Cholesterol in Phase III rehabilitation Time Frame: 12months	Venous blood samples are drawn to assess Cholesterol at the start and end of Phase III rehabilitation	12months
Change from baseline in Triglycerides in Phase III rehabilitation Time Frame: 12months	Venous blood samples are drawn to assess Triglycerides at the begin and end of Phase III	12months
Change from baseline in Glucose in Phase III rehabilitation Time Frame: 12months	Venous blood samples are drawn to assess Triglycerides at the begin and end of Phase III	12months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Josef Niebauer M.D., Ph.D., MBA

Investigators

Study Director: Josef Niebauer, MD, PhD, MBA, Paracelsus Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2022

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

June 21, 2022

First Submitted That Met QC Criteria