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临床试验/NCT02775305
NCT02775305Unknown不适用

The Effects of Frailty on Chronic Kidney Disease

San Francisco Veterans Affairs Medical Center2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
2
主要终点
Physical Function

研究概览

简要总结

Frailty is a syndrome characterized by decreased reserve and diminished resistance to stressors. The proposed research will evaluate the association of frailty with chronic kidney disease (CKD). The prevalence of frailty increases with age and with CKD, but studies are needed to determine whether frailty is associated with worsening of CKD and whether intervention to treat frailty can improve physical functioning and health-related quality of life (HRQOL) as well as slow progression of CKD.

详细描述

The intervention is a 6-month prospective interventional pilot study targeted to each domain of frailty. Subjects will be screened into the study by testing each domain; only those who meet criteria for frailty will be included in the study. The clinical intervention, which all subjects will receive, will begin immediately upon enrollment and completion of baseline measurements. Upon enrollment the 3 most recent previous outpatient serum creatinine measurements (up to 1 year) will be used to determine baseline slope of estimated glomerular filtration rate (eGFR). The main objectives of the pilot study will be to gain knowledge in the successful implementation and completion of an intervention targeted toward frailty. Ultimately information ascertained from this pilot will serve as a springboard for planning of a randomized trial aimed at addressing all the domains of frailty, which is key given that previous studies have only implemented interventions aimed at a single domain or in pairs, but no studies have evaluated the extent to which frailty can be reversed through a cohesive intervention addressing all domains together. The intervention outlined in this proposal is comprehensive and focused while maintaining feasibility.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic Kidney Disease Stage III to IV
  • Receiving care at the San Francisco Veterans Affairs Medical Center
  • Able to consent in English

排除标准

  • Early chronic kidney disease
  • individuals with acute kidney injury
  • non-ambulatory

结局指标

主要结局

Physical Function

时间窗: baseline and 6 months

Change in physical functioning will be assessed using the short physical performance battery (SPPB). Investigators will compare baseline Short physical performance battery (SPPB) score to 6 month score to determine change in functioning as a result of the intervention.

Pedometer Step Count

时间窗: Change from baseline step count to 6 months

The number of steps achieved over the 6 month period will be assessed. Pedometer data is collected each week. Based on the weekly achieved counts a new goal is generated for each participant. This assessment will include study investigators collecting step count logs from the participant on a weekly basis.

次要结局

未报告次要终点

研究者

发起方
San Francisco Veterans Affairs Medical Center
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Cynthia Delgado

Staff Physician

San Francisco Veterans Affairs Medical Center

研究点 (2)

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