- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04458727
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.
Panoramica dello studio
Stato
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Upper Austria
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Linz, Upper Austria, Austria, 4020
- Reclutamento
- Cardiomed Kardiologisches Rehabilitationszentrum GmbH Linz
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Contatto:
- Karl Mayr, Dr.
- Numero di telefono: 0732 797779
- Email: Karl.Mayr@cardiomed.at
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Age >= 18 years
- Participation rehabilitation phase III new
- Documented cardiovascular disease
- Signed informed-consent
Exclusion Criteria:
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Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Altro
- Prospettive temporali: Altro
Coorti e interventi
Gruppo / Coorte |
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Patients who used supportive measures during home training
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patients who did not use supp. measures during home training
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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The change of maximal workload during ergometry pre and post home-training
Lasso di tempo: 1 year
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1 year
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Collaboratori e investigatori
Collaboratori
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- EPICURE
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .