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

Auswertung Von Multi-modalen unterstützenden Maßnahmen in Der Ambulant Kardiologischen Rehabilitation Bei Patienten Mit Einer kardiovaskulären Erkrankung

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.

Study Overview

• Status: Unknown
• Conditions: Evaluation of Multi-modal Supportive Actions in Outpatient Cardiac Rehabilitation in Subjects With Cardiovascular Disease

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Angelika Rzepka, MSc; Phone Number: 0043 664 8561598; Email: angelika.rzepka@ait.ac.at
• Study Contact Backup: Name: Dieter Hayn, Dr.; Phone Number: 0043 50550 2953; Email: dieter.hayn@ait.ac.at

Study Locations

• Austria
  • Upper Austria
    • Linz, Upper Austria, Austria, 4020
      • Recruiting
      • Cardiomed Kardiologisches Rehabilitationszentrum GmbH Linz
      • Contact: Karl Mayr, Dr.; Phone Number: 0732 797779; Email: Karl.Mayr@cardiomed.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The change of maximal workload during ergometry pre and post home-training	1 year

Collaborators and Investigators

• Sponsor: AIT Austrian Institute of Technology GmbH
• 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

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Anticipated): September 9, 2020
• Study Completion (Anticipated): September 9, 2020

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: rehabilitation; cardiovascular disease; outpatient cardiac rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: EPICURE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No