Abstract
BackgroundFrailty describes an age-related clinical state and can be regarded as a predictive factor for fall, disability, hospitalization, and death in the elderly. Previous studies proved that frailty could be reversed or attenuated by multi-disciplinary intervention. However, only a few studies have been performed in non-dialysis patients with chronic kidney disease.MethodsA randomized parallel controlled trial will be conducted to compare an individualized intervention according to the consequence of the comprehensive geriatric assessment with routine treatment. A total of 242 individuals aged ≥65 years, who fulfill the Fried Phenotype of frailty and have chronic kidney disease stage 3–5 without dialysis will be recruited from the Department of Nephrology and Department of Internal Medicine, Beijing Chaoyang Hospital, Capital Medical University. The participants will be followed-up for 30 days and 12 months.DiscussionThis protocol would be established to examine the efficiency of targeted intervention for frailty. If a positive consequence could be obtained, a novel treatment for frail elderly patients with chronic kidney disease who have never undergone dialysis can be carried out in routine clinical practice.Trial registrationThe trial was prospectively registered at the Chinese Clinical Trials Registry with the registration number ChiCTR-IOR-17013429 on November 17, 2017.
Highlights
Frailty describes an age-related clinical state and can be regarded as a predictive factor for fall, disability, hospitalization, and death in the elderly
The accelerated speed of aging and the heterogeneity of elderly have led to an increasing focus on the frailty, which is recognized as an age-associated state of increased vulnerability to external stressors resulting from the decreased physiological reserve function of multiple
Despite the prevalence of frailty and its association with negative outcomes, it can be overlooked owing to the lack of the corresponding chief complaint or the manifestations encompassed by comorbidity [9]
Summary
Design outline A single center randomized parallel controlled trial with a follow-up period of 30 days and 12 months will be conducted. All eligible participants will be randomized (1:1 allocation ratio) into control and intervention groups, and the latter would receive individualized interventions according to the consequence of the comprehensive geriatric assessment (CGA). The informed consents will be signed after the eligible patients agree to participate in the investigation and allow access to their data during the follow-up either by clinic or telephone contact. For participants with normal physical performance in the intervention group and those in the control group, physical activities will be encouraged and a customized exercise program will not be prepared. Demographic information, concomitant diseases, echocardiography data and laboratory variables of participants will be collected from the data system of Beijing Chaoyang Hospital, Capital Medical University.
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