NCT05432921

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 27, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

April 13, 2023

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

June 21, 2022

Last Update Submit

April 11, 2023

Conditions

Keywords

cardiac rehabilitationexercise traininglifestyle modificationcoronary-artery-diseasemyocardial infarction

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Change from baseline in LDL-Cholesterol in Phase III rehabilitation

    12months

  • Change from baseline in Triglycerides in Phase III rehabilitation

    12months

  • Change from baseline in Glucose in Phase III rehabilitation

    12months

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Salzburg, 5020, Austria

Location

Related 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.

    PMID: 28476924BACKGROUND
  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Cardiovascular DiseasesCoronary Artery DiseaseMyocardial Infarction

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Josef Niebauer, MD, PhD, MBA

    Paracelsus Medical University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Institute

Study Record Dates

First Submitted

June 21, 2022

First Posted

June 27, 2022

Study Start

September 27, 2022

Primary Completion

August 1, 2023

Study Completion

December 31, 2023

Last Updated

April 13, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations