NCT03463486

Brief Summary

Aim of this study is to give evidence to outpatient cardiac rehabilitation in Austria. The database created in this context is supposed to pave the way as instrument to document and comprehend quality of outpatient cardiac rehabilitation in Austria as a key for quality management. Analyses of the created database should be made on a regular basis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2005

Completed
12.8 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 13, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

13.9 years

First QC Date

October 17, 2017

Last Update Submit

April 22, 2022

Conditions

Cardiovascular Diseases

Keywords

outpatient cardiac rehabilitation, exercise training,

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in Physical Work Capacity (PWC) in Phase II rehabilitation

    PWC is measured by a graded exercise test on a cycle ergometer at start and end of outpatient cardiac rehabilitation

    6 weeks

  • Change from baseline in Physical Work Capacity (PWC) in Phase III rehabilitation

    PWC is measured by a graded exercise test on a cycle ergometer at start and end of outpatient cardiac rehabilitation

    1 year

Secondary Outcomes (6)

  • Change from baseline in Cholesterol in Phase II rehabilitation

    6 weeks

  • Change from baseline in Cholesterol in Phase III rehabilitation

    1 year

  • Change from baseline in Triglycerides in Phase II rehabilitation

    6 weeks

  • Change from baseline in Triglycerides in Phase III rehabilitation

    1 year

  • Change from baseline in Blood Glucose in Phase II rehabilitation

    6 weeks

  • +1 more secondary outcomes

Interventions

Physical activityBEHAVIORAL

50min of endurance training combined with 50min of calisthenics; 1-3x/wekk; 6weeks up to 1year

Eligibility Criteria

Age12 Years - 99 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who qualified for an outpatient cardiac rehabilitation

You may not qualify if:

  • Medical conditions which prevent patients from complying with the exercise program
  • Acute infections
  • Hypertrophic cardiomyopathy
  • Pulmonary artery embolism or phlebothrombosis within the previous 6 months
  • Unstable angina pectoris
  • Heart failure (NYHA IV)
  • Hemodynamically unstable arrhythmia

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)

  • Niebauer J, Hambrecht R, Velich T, Hauer K, Marburger C, Kalberer B, Weiss C, von Hodenberg E, Schlierf G, Schuler G, Zimmermann R, Kubler W. Attenuated progression of coronary artery disease after 6 years of multifactorial risk intervention: role of physical exercise. Circulation. 1997 Oct 21;96(8):2534-41. doi: 10.1161/01.cir.96.8.2534.

    PMID: 9355890BACKGROUND

  • 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

  • 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.

    PMID: 24615677RESULT

Related Links

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Prof. Josef Niebauer, MD, PhD, MBA

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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the Institute

Study Record Dates

First Submitted

October 17, 2017

First Posted

March 13, 2018

Study Start

January 1, 2005

Primary Completion

December 1, 2018

Study Completion

December 1, 2021

Last Updated

April 25, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)