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临床试验/NCT02818010
NCT02818010已完成不适用

Impact of Physical Activity on Patients With Chronic Kidney Disease Not Receiving Dialysis Followed in the TIRCEL Network. An Exposed / Unexposed Study (PHYSALYS)

Hospices Civils de Lyon0 个研究点目标入组 259 人开始时间: 2012年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
259
主要终点
Change of the Glomerular Filtration Rate (GFR)

研究概览

简要总结

PHYSALYS is an observational multicenter study. It's an analytical study comparing 2 groups: patients exposed to physical activity and unexposed. The main objective of the study is to compare the evolution of glomerular filtration rate at inclusion and 12 months later between patients practicing physical activity and patients not practicing. If necessary, the renal disease-related complications, which are not influenced by physical activity: (type of kidney disease, age and tobacco), would be taken into account. TIRCEL patients with chronic kidney disease (CKD) at stages 3, 4 or 5 can be included in the study. Their serum creatinine data, 12 months prior to inclusion, is collected retrospectively. Patients are followed in the trial during 12 months. To evaluate physical activity, patients respond to Global Physical Activity Questionnaire 2 (GPAQ2) at inclusion and 12 months later. During this 12 months period, the same biological data are collected prospectively.

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

  • Members of TIRCEL (Traitement de l'Insuffisance Chronique en rhônE-aLpes) network for over a year and having at least two measurements of glomerular filtration rate with an interval of 9 to 12 months between the first and the last measurement
  • Patients in stages 3, 4 or 5 of CKD
  • No dialysis CKD patients
  • Non transplanted CKD patients
  • Patients seeing nephrologist
  • Patients agreeing to be contacted for a phone call half an hour
  • Adults patients (> 18 years)
  • Patients not living in institution
  • Patients being able to answer a questionnaire

排除标准

  • Patients followed in the TIRCEL (Traitement de l'Insuffisance Chronique en rhônE-aLpes) network for less than one year or having less than 2 measurements of glomerular filtration rate with an interval of least 9 months or over 12 months between the first and the last measurement
  • Patients in stages 1 or 2 of CKD
  • CKD patients receiving dialysis
  • Transplanted CKD patients
  • Patients not seeing nephrologist
  • Patients refusing to be contacted for a phone call half an hour
  • Patients < 18 years
  • Patients living in institution
  • Patients unable to answer a questionnaire

结局指标

主要结局

Change of the Glomerular Filtration Rate (GFR)

时间窗: Month 0, Month 12

The Glomerular Filtration Rate (GFR) annual slope between inclusion (M0) and 12 months (M12) after inclusion in exposed and unexposed groups.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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