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Evaluation of Multi-modal Supportive Actions in Outpatient Cardiac Rehabilitation in Subjects With Cardiovascular Disease (EPICURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04458727
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborators:
Cardiomed Kardiologisches Rehabilitationszentrum GmbH Linz
PKA Private Krankenanstalt Wels Betriebs Gesellschaft mit b. H.
Gemeinnützige Salzburger Landeskliniken Betriebsgesellschaften
Medreha GmbH
ZARG - Zentrum für ambulante Rehabilitation Graz GmbH
REHAmed-tirol GmbH Innsbruck
Universität Innsbruck
Information provided by (Responsible Party):
AIT Austrian Institute of Technology GmbH

Brief 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.


Condition or disease
Evaluation of Multi-modal Supportive Actions in Outpatient Cardiac Rehabilitation in Subjects With Cardiovascular Disease

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Other
Time Perspective: Other
Official Title: Auswertung Von Multi-modalen unterstützenden Maßnahmen in Der Ambulant Kardiologischen Rehabilitation Bei Patienten Mit Einer kardiovaskulären Erkrankung
Actual Study Start Date : December 10, 2019
Estimated Primary Completion Date : September 9, 2020
Estimated Study Completion Date : September 9, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Patients who used supportive measures during home training
patients who did not use supp. measures during home training



Primary Outcome Measures :
  1. The change of maximal workload during ergometry pre and post home-training [ Time Frame: 1 year ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who undergo the final examination for OUT-III at one of the outpatient rehabilitation facilities participating in the study are checked by the examining physician for the above-mentioned inclusion and exclusion criteria. Patients will be included if they are willing to participate and sign the consent form.
Criteria

Inclusion Criteria:

  • Age >= 18 years
  • Participation rehabilitation phase III new
  • Documented cardiovascular disease
  • Signed informed-consent

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04458727


Contacts
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Contact: Angelika Rzepka, MSc 0043 664 8561598 angelika.rzepka@ait.ac.at
Contact: Dieter Hayn, Dr. 0043 50550 2953 dieter.hayn@ait.ac.at

Locations
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Austria
Cardiomed Kardiologisches Rehabilitationszentrum GmbH Linz Recruiting
Linz, Upper Austria, Austria, 4020
Contact: Karl Mayr, Dr.    0732 797779    Karl.Mayr@cardiomed.at   
Sponsors and Collaborators
AIT Austrian Institute of Technology GmbH
Cardiomed Kardiologisches Rehabilitationszentrum GmbH Linz
PKA Private Krankenanstalt Wels Betriebs Gesellschaft mit b. H.
Gemeinnützige Salzburger Landeskliniken Betriebsgesellschaften
Medreha GmbH
ZARG - Zentrum für ambulante Rehabilitation Graz GmbH
REHAmed-tirol GmbH Innsbruck
Universität Innsbruck
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Responsible Party: AIT Austrian Institute of Technology GmbH
ClinicalTrials.gov Identifier: NCT04458727    
Other Study ID Numbers: EPICURE
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AIT Austrian Institute of Technology GmbH:
rehabilitation
cardiovascular disease
outpatient cardiac rehabilitation
Additional relevant MeSH terms:
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Cardiovascular Diseases