Outpatient Cardiac Rehabilitation in Austria | NCT01540006

Studies
Outpatient Cardiac Rehabilitation in Austria

NCT01540006

Sponsor

Paracelsus Medical University

Status

Completed

Last Update Posted

Oct 18, 2017Actual

Enrollment

1,200Actual

Phase

Not provided

Conditions

Heart Disease

Interventions

Physical activity

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

May 2014Actual

Completion Date

May 2014Actual

First Submitted Date

Feb 22, 2012

First Submission Date that Met QC Criteria

Feb 27, 2012

First Posted Date

Feb 28, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2017

Last Update Posted Date

Oct 18, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof. Josef Niebauer M.D., Ph.D., MBA, Head of institute, Paracelsus Medical UniversityPrincipal Investigator

Lead Sponsor

Paracelsus Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this prospective trial is the manifestation of guidelines developed for outpatient cardiac rehabilitation in Austria.

The evaluation of prospective and retrospective data is supposed to give evidence on morbidity and/or mortality advantages compared to patients not participating in cardiac rehabilitation programs.

The database created in this context is supposed to pave the way as instrument to document and comprehend quality and cost effectiveness of outpatient cardiac rehabilitation in Austria as a key for quality management.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physical activity	Other	50min of endurance training combined with 45min of calisthenics; 1-3x/week; 6-24 weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Physical work capacity (PWC)	PWC is measuered by gradded exercise test on cycling ergometer before and after rehabilitation.	6 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

heart disease

Exclusion Criteria:

participation in another study within the previous 6 months
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Any patients with heart disease willing to participate in an ambulant cardiac rehabilitation.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Prof. Josef Niebauer, MD, PhD, MBA	Paracelsus Medical University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University		Salzburg		5020	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19351942	Background	Flynn KE, Pina IL, Whellan DJ, Lin L, Blumenthal JA, Ellis SJ, Fine LJ, Howlett JG, Keteyian SJ, Kitzman DW, Kraus WE, Miller NH, Schulman KA, Spertus JA, O'Connor CM, Weinfurt KP; HF-ACTION Investigators. Effects of exercise training on health status in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1451-9. doi: 10.1001/jama.2009.457.
9355890

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena