跳至主要内容
临床试验/NCT06150235
NCT06150235尚未招募不适用

Impact of Physical Activity on Quality of Life for Chronic Hemodialysis Patients

Université de Reims Champagne-Ardenne2 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2024年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
750
试验地点
2
主要终点
Health-related quality of life using SF-36 survey

研究概览

简要总结

Chronic end-stage renal disease has a significant impact on patients' quality of life. In 2005, a study evaluating the quality of life of patients with end-stage chronic kidney disease using the SF-36 and KDQoL questionnaires showed that the proportion of patients with an altered quality of life varied from 20% to 50% in the physical component dimensions and from 12% to 47% in the mental component dimensions. More than 75% of dialysis patients had at least one of the 8 scores below the threshold that defines impaired quality of life. In 2011, the Quavi-REIN study involved 1251 dialysis patients showed a significant reduction of quality of life assessed using the generic SF36 questionnaire compared with the general population, in the physical and mental dimensions.

Moreover, in France, more than one senior citizens aged between 55 and 74 in three does not comply with the World Health Organisation's recommendations on the minimum level of physical activity required per day. A sedentary lifestyle is a major public health problem. It is the 4thrisk factor for mortality after hypertension, smoking and diabetes. This inactivity increases mortality and morbidity rates in humans, and consequently the risk of diseases such as cancer and type 2 diabetes.

Physical activity is recommended for patients with chronic kidney disease. In a survey of 505 nephrologists, 97% thought that physical activity is beneficial for dialysis patients, given that a sedentary lifestyle increases the death rate among dialysis patients. Data from the international DOPPS registry, involving 20,920 patients, showed that patients who engage in physical activity have a better quality of life (physical, psychological and sleep quality components), as assessed by the KDQoL-SF questionnaire.

详细描述

The main objective is to study factors associated with the quality of life of hemodialysis patients, including physical activity.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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

  • Hemodialysis
  • Agreeing to participate in the study

排除标准

  • On peritoneal dialysis
  • On daily dialysis at home
  • Protected by law (guardianship, curatorship, safeguarding of justice)
  • Refusing to participate in the study

结局指标

主要结局

Health-related quality of life using SF-36 survey

时间窗: Day 0

Health-related quality of life will be evaluated by the generic questionnaire "Medical Outcomes Study ShortForm General Health Survey" (SF-36) created in 1992 by Ware and Sherbourne and validated in French by Leplège in 1998 The SF-36 is a questionnaire containing 36 items, covering the four weeks preceding the time when the subject is interviewed, grouped into 8 dimensions. Each question is assessed on a Likert scale, with 3, 5 or 6 possible answer levels. The score for each dimension varies from 0 to 100, the higher the score and the better the quality of life.

次要结局

  • Health-related quality of life using KDQOL survey(Day 0)
  • Physical activity using RICCI GAGNON test(Day 0)

研究者

发起方
Université de Reims Champagne-Ardenne
申办方类型
Other
责任方
Sponsor

研究点 (2)

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