Prevalence of Frailty in Patients With a Cardiovascular Disease and Correlations With Markers of Exercise
In the first part of this study the prevalence of frailty in patients with cardiovascular disease will be examined. Frailty is defined as a progressive age-related decline in physiological systems that results in decreased reserves of intrinsic capacity, which confers extreme vulnerability to stressors. Patients (≥65 years, men and women) suffering from heart failure or undergoing a coronary artery bypass grafing (CABG) or percutaneous coronary intervention (PCI) will be included. Based on the phenotype of Fried, frailty will be examined in the physical domain. Moreover, the nutritional, social, psychological and cognitive domain of frailty will be examined. This will result in a total score of 0 (no frailty) to 24 (severe frailty), divided into four categories: no frailty (score 0-6), minor frailty (score 7-12), moderate frailty (score 13-18) or severe frailty (score 18-24).
Besides this frailty protocol, a few other measurements will be completed to collect additional information about the functioning of the patient.
At discharge from the hospital, some of these patients will start with a cardiac rehabilitation program. To define the exercise intensity of this program, patients will perform a maximal exercise test (CPET). In the second part of this study, correlations will be examined between markers of frailty and markers of exercise from the CPET (e.g. maximal heart rate, maximal oxygen uptake).
Panoramica dello studio
Stato
Condizioni
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Limburg
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Hasselt, Limburg, Belgio, 3500
- Jessa Hospital Campus Virga Jesse
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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:
Men and women with an age of at least 65 years at the start of the study; Staying in Jessa Hospital for PCI, CABG or heart failure
Exclusion Criteria:
A persistently unstable clinical condition at baseline visit (angina, advanced conduction disturbances, threatening ventricular arrhythmias, acute heart failure, clinical condition requiring interventions such as acute renal failure, Hb <9,0 mg/dl, presence of end-stage disease or the lack of informed consent to study participation)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Altro
- Prospettive temporali: Trasversale
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Level of (in)dependence via the Katz scale
Lasso di tempo: At baseline
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Evaluation of the level of (in)dependence in activities of daily life via a 4-point scale (1-4)
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At baseline
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Nutritional status via the Mini Nutritional Assessment (MNA)
Lasso di tempo: At baseline
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Examination of the nutritional status of the patient via a questionnaire (30 points)
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At baseline
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Level of physical activity via the International Physical Activity Questionnaire (IPAQ)
Lasso di tempo: At baseline
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Examination of the level of physical activity of the patient via a questionnaire
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At baseline
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Cognitive status via the Mini Mental State Examination (MMSE)
Lasso di tempo: At baseline
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Examination of the cognitive status of the patient via a short screening (30 points)
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At baseline
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Psychological status via the Geriatric Depression Scale (GDS-15)
Lasso di tempo: At baseline
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Examination of the presence/absence of a depressive mood via a questionnaire (15 questions/15 points)
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At baseline
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Concern about falling via the Falls Efficacy Scale (FES-I)
Lasso di tempo: At baseline
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Examination of the level of concern about falling during social and physical activities via a questionnaire (16 questions/ 64 points)
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At baseline
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Weight loss via the evaluation of body weight
Lasso di tempo: At baseline
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Evaluation of involuntary loss of body weight in the previous months
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At baseline
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Gait speed via the 4.6 meter walking test
Lasso di tempo: At baseline
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Examination of the walking speed of the patient
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At baseline
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Evaluation of handgrip strength
Lasso di tempo: At baseline
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Evaluation of the handgrip strength of the patient via handheld dynamometry
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At baseline
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Examination of mobility/balance/muscle strength/risk of falling via the Timed Up and Go Test (TUG)
Lasso di tempo: At baseline
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The Timed Up and Go Test measures the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
By combining this test with a motor or cognitive dual task, the risk of falling of the patient will be examined.
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At baseline
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Comorbidities via the record of medication use
Lasso di tempo: At baseline
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Record of cardiac and other medications
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At baseline
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Evaluation of lower limb strength
Lasso di tempo: At baseline
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Evaluation of lower limb strength of the patient via Microfet measurements
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At baseline
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Evaluation of functional lower limb strength
Lasso di tempo: At baseline
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Evaluation of functional lower limb strength of the patient via the Timed Chair Stand Test
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At baseline
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Correlations between frailty (via the primary frailty outcome measures) and exercise parameters (via the maximal exercise test (CPET)
Lasso di tempo: At the start of the cardiac rehabilitation program
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Evaluation of correlations between frailty characteristics (from the primary outcome measures) and exercise parameters from a maximal exercise test (CPET) (performed at the start of a cardiac rehabilitation program).
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At the start of the cardiac rehabilitation program
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Collaboratori e investigatori
Sponsor
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
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
- FrCR
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