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

NCT ID: NCT04458727

Last Updated: 2020-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-10

Study Completion Date

2020-09-09

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Patients who used supportive measures during home training

No interventions assigned to this group

patients who did not use supp. measures during home training

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiomed Kardiologisches Rehabilitationszentrum GmbH Linz

UNKNOWN

Sponsor Role collaborator

PKA Private Krankenanstalt Wels Betriebs Gesellschaft mit b. H.

UNKNOWN

Sponsor Role collaborator

Gemeinnützige Salzburger Landeskliniken Betriebsgesellschaften

UNKNOWN

Sponsor Role collaborator

Medreha GmbH

UNKNOWN

Sponsor Role collaborator

ZARG - Zentrum für ambulante Rehabilitation Graz GmbH

UNKNOWN

Sponsor Role collaborator

REHAmed-tirol GmbH Innsbruck

UNKNOWN

Sponsor Role collaborator

Universität Innsbruck

UNKNOWN

Sponsor Role collaborator

AIT Austrian Institute of Technology GmbH

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cardiomed Kardiologisches Rehabilitationszentrum GmbH Linz

Linz, Upper Austria, Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Angelika Rzepka, MSc

Role: CONTACT

0043 664 8561598

Dieter Hayn, Dr.

Role: CONTACT

0043 50550 2953

Facility Contacts

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Karl Mayr, Dr.

Role: primary

0732 797779

Other Identifiers

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EPICURE

Identifier Type: -

Identifier Source: org_study_id

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