- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT04206904
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).
Visão geral do estudo
Status
Condições
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Limburg
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Hasselt, Limburg, Bélgica, 3500
- Jessa Hospital Campus Virga Jesse
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Outro
- Perspectivas de Tempo: Transversal
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Level of (in)dependence via the Katz scale
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: At baseline
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Examination of the cognitive status of the patient via a short screening (30 points)
|
At baseline
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Psychological status via the Geriatric Depression Scale (GDS-15)
Prazo: 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)
Prazo: 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
Prazo: At baseline
|
Evaluation of involuntary loss of body weight in the previous months
|
At baseline
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Gait speed via the 4.6 meter walking test
Prazo: 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
Prazo: At baseline
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Evaluation of the handgrip strength of the patient via handheld dynamometry
|
At baseline
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Examination of mobility/balance/muscle strength/risk of falling via the Timed Up and Go Test (TUG)
Prazo: At baseline
|
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
Prazo: 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
Prazo: 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
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Correlations between frailty (via the primary frailty outcome measures) and exercise parameters (via the maximal exercise test (CPET)
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- FrCR
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