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临床试验/NCT04860440
NCT04860440Unknown不适用

A Feasibility Study of a Wrist Worn Accelerometer to Characterise the Physical Activity of Patients With End-stage Renal Disease (W-WARD Study).

Cambridge University Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年7月最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
1
主要终点
Acceptability

研究概览

简要总结

The kidneys are important at getting rid of toxins and excess water from the body. If they fail, then toxins and excess water builds up within the body. Kidney failure is treated by either giving patients a new kidney (a transplant) or by removing the toxins and fluid from the body by the process of dialysis.

The investigators' aim is to personalise the care given to patients with kidney failure, and as such, they have started measuring the fitness of patients with kidney failure, who either already require dialysis or may need dialysis in the near future. This is currently done in a number of ways including measuring how strong their grip is, assessing their walking speed and asking questions about how difficult they find certain activities.

In the future, the investigators think that this will allow targeted treatments to help improve their fitness and potentially identify any problems earlier.

Current approaches to measuring activity and fitness have limitations and in particular may over- or underestimate the level of the physical activity. To over come these limitations, participants will be asked to wear an activity tracker (called an accelerometer) on for a week. Readings from the accelerometer will be compared against the other markers of fitness and activity to see if they are comparable. It will also be noted whether patients are prepared to wear the device for 7 days (compliance).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Aged over 18 years with low clearance pre-dialysis and referred to the Low Clearance Clinic with estimated Glomerular Filtration Rate (eGFR) less than 20 ml/min/1.73m and / or commenced on haemodialysis
  • Able to give informed consent

排除标准

  • Significant resting tremor of any aetiology or severe Parkinson's Disease
  • Arteriovenous fistulas in both arms
  • Any scheduled inpatient treatment or day case treatment in next 7 days.

结局指标

主要结局

Acceptability

时间窗: 7 days

The acceptability of physical activity measures in frailty assessment in patients from the low clearance and dialysis clinic as determined by the percentage of time, device worn during the 7-day period.

次要结局

  • Clinical Frailty Scale (no units)(1 day)
  • 10 Point Cognitive Screener (no units)(1 day)
  • Measurement of physical activity by the accelerometer(7 days)
  • Fried Frailty Phenotype (no units)(1 day)
  • Grip strength (in kilograms)(1 day)
  • Walking speed (in seconds measured over 15 feet)(1 day)
  • 4AT Assessment Tool of Cognitive Impairment (no units)(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James Richards

Academic Clinical Lecturer & Senior Clinical Fellow in HPB & Transplantation Surgery

Cambridge University Hospitals NHS Foundation Trust

研究点 (1)

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