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

• Sponsor: AIT Austrian Institute of Technology GmbH (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04458727
• Collaborator: Cardiomed Kardiologisches Rehabilitationszentrum GmbH Linz (Other), PKA Private Krankenanstalt Wels Betriebs Gesellschaft mit b. H. (Other), Gemeinnützige Salzburger Landeskliniken Betriebsgesellschaften (Other), Medreha GmbH (Other), ZARG - Zentrum für ambulante Rehabilitation Graz GmbH (Other), REHAmed-tirol GmbH Innsbruck (Other), Universität Innsbruck (Other)
• Enrollment: 150
• Location: 1
• Anticipated Duration (Months): 9
• Patients Per Site Per Month: 16.7

Study Details

Study Description

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	Intervention/Treatment	Phase
Evaluation of Multi-modal Supportive Actions in Outpatient Cardiac Rehabilitation in Subjects With Cardiovascular Disease

Study Design

• Study Type: Observational
• Anticipated 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: Dec 10, 2019
• Anticipated Primary Completion Date: Sep 9, 2020
• Anticipated Study Completion Date: Sep 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
Patients who used supportive measures during home training
patients who did not use supp. measures during home training

Outcome Measures

Primary Outcome Measures

1. The change of maximal workload during ergometry pre and post home-training [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age >= 18 years

• Participation rehabilitation phase III new

• Documented cardiovascular disease

• Signed informed-consent

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiomed Kardiologisches Rehabilitationszentrum GmbH Linz	Linz	Upper Austria	Austria	4020

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AIT Austrian Institute of Technology GmbH
• ClinicalTrials.gov Identifier: NCT04458727
• Other Study ID Numbers: EPICURE
• First Posted: Jul 7, 2020
• Last Update Posted: Jul 7, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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: Cardiovascular Diseases

Study Results

No Results Posted as of Jul 7, 2020