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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04458727
Other study ID # EPICURE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 10, 2019
Est. completion date September 9, 2020

Study information

Verified date July 2020
Source AIT Austrian Institute of Technology GmbH
Contact Angelika Rzepka, MSc
Phone 0043 664 8561598
Email angelika.rzepka@ait.ac.at
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Cariovascular diseases (CVD) are the most common cause of death worldwide with high micro- as well as macro-economic burden. Several modifiable risk factors increase the probability of contracting a CVE. These risk factors can be positively influenced by a cardiac rehabilitation measure (CR), which has been shown to reduce mortality in CVD patients and to reduce the economic burden. An increase in physical activity and performance are central goals in CR, as they have a positive effect on several cardiovascular risk factors and correlate strongly with a reduction in mortality in CVD patients. These goals can be achieved in most CVD patients but can only be achieved by a modification of lifestyle.

In order to positively influence this lifestyle modification beyond the duration of the CR measure and thus in the long term, CR Phase II should begin as soon as the patient fulfils one of the well-defined inclusion criteria. CR Phase II can be carried out as an inpatient or outpatient procedure and depends on the patient's state of health, personal preference and availability of an outpatient CR facility in the vicinity of the patient. In the Austrian healthcare system, inpatient CR and thus differs from other European countries. After completion of phase II, the patient is offered an outpatient phase III with weekly visits to the outpatient CR facility, so that lifestyle changes achieved at short notice can be sustainably maintained.

For the secondary prevention of the CVD beyond the CR measure recommend international guidelines a physical activity of ≥ 150 min with moderate intensity or ≥ 60 to 75 min high intensity per week. The current study situation allows the statement that a greater benefit can be expected from more physical activity and that the training should be personalized and highly titrated. Patients in advanced stages of CVD and very inactive patients, defined as <14 mets h/week, achieve the greatest health benefit from increased physical activity. Despite the well-studied benefits, even adherence to the above minimum recommendations for CVD patients after completion of CR is low. This deficit has been addressed in the latest European prevention guideline and recommended that patients i) set clearly defined goals, ii) exercise in the iii) Identify obstacles on the way to achieving the goals so that lifestyle changes are effective and sustainable and the benefits of physical activity can be achieved and maintained.

The planned study will investigate the effect of multi-modal support measures to help patients during the home training phase and their influence on the patients' lifestyle.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date September 9, 2020
Est. primary completion date September 9, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- Age >= 18 years

- Participation rehabilitation phase III new

- Documented cardiovascular disease

- Signed informed-consent

Exclusion Criteria:

-

Study Design


Related Conditions & MeSH terms

  • Cardiovascular Diseases
  • Evaluation of Multi-modal Supportive Actions in Outpatient Cardiac Rehabilitation in Subjects With Cardiovascular Disease

Locations

Country Name City State
Austria Cardiomed Kardiologisches Rehabilitationszentrum GmbH Linz Linz Upper Austria

Sponsors (8)

Lead Sponsor Collaborator
AIT Austrian Institute of Technology GmbH Cardiomed Kardiologisches Rehabilitationszentrum GmbH Linz, Gemeinnützige Salzburger Landeskliniken Betriebsgesellschaften, Medreha GmbH, PKA Private Krankenanstalt Wels Betriebs Gesellschaft mit b. H., REHAmed-tirol GmbH Innsbruck, Universität Innsbruck, ZARG - Zentrum für ambulante Rehabilitation Graz GmbH

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary The change of maximal workload during ergometry pre and post home-training 1 year