Clinical trial NCT04458727: Evaluation of Multi-modal Supportive Actions in Outpatient Cardiac Rehabilitation in Subjects With Cardiovascular Disease
Official title: Auswertung Von Multi-modalen unterstützenden Maßnahmen in Der Ambulant Kardiologischen Rehabilitation Bei Patienten Mit Einer kardiovaskulären Erkrankung
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Evaluation of Multi-modal Supportive Actions in Outpatient Cardiac Rehabilitation in Subjects With Cardiovascular Disease
Keywords: rehabilitation
cardiovascular disease
outpatient cardiac rehabilitation
Lead sponsor: AIT Austrian Institute of Technology GmbH
Sponsor class: OTHER
Collaborators: name: Cardiomed Kardiologisches Rehabilitationszentrum GmbH Linz
name: PKA Private Krankenanstalt Wels Betriebs Gesellschaft mit b. H.
name: Gemeinnützige Salzburger Landeskliniken Betriebsgesellschaften
name: Medreha GmbH
name: ZARG - Zentrum für ambulante Rehabilitation Graz GmbH
name: REHAmed-tirol GmbH Innsbruck
name: Universität Innsbruck
First posted: 2020-07-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: The change of maximal workload during ergometry pre and post home-training
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Cardiomed Kardiologisches Rehabilitationszentrum GmbH Linz
state: Upper Austria
Study officials:
References: