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临床试验/NCT07118007
NCT07118007尚未招募不适用

Assessment of the Benefits of Adapted Physical Activity in Pediatric Hemodialysis Patients-DIALAPA Study

Hospices Civils de Lyon0 个研究点目标入组 15 人开始时间: 2025年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
15
主要终点
mass-to-muscle mass ratio between M0 and M6

研究概览

简要总结

Children, adolescents, and young adults undergoing pediatric hemodialysis often experience functional limitations in daily life. Their level of physical activity is generally lower than that of healthy peers of the same age, due to the lack of sports programs adapted both to their medical conditions and to the constraints of dialysis (notably, having to remain in bed for several hours, several times a week). These limitations affect not only their cardiovascular function but also their quality of life.

Through the implementation of an Adapted Physical Activity (APA) program for dialysis patients, we aim to assess the potential benefits of this approach on muscle strength, functional abilities, cardiovascular health, and quality of life

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
5 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patient requiring hemodialysis sessions for end-stage renal disease
  • •Patient aged between 5 and 20 years
  • •Patient followed in the pediatric nephrology department at hospital Lyon (HFME : Hôpital Femme Mère Enfant)
  • •Adult patient or parents/legal guardians informed about the study and having provided written consent for participation
  • •Patient covered by a social security

排除标准

  • •Medical or surgical contraindications to adapted physical activity.
  • •Persons deprived of liberty by judicial or administrative decision.
  • •Persons undergoing psychiatric care.
  • •Persons admitted to a healthcare or social facility for reasons other than research participation.
  • •Adults under legal protection measures (curators)
  • •Persons not affiliated with a social security scheme or beneficiaries of a similar system
  • •Pregnant women.

研究组 & 干预措施

Patient requiring hemodialysis for end-stage renal disease

Other

Patient requiring hemodialysis for end-stage renal disease aged 5 to 20 years

干预措施: adapted physical activity (Other)

结局指标

主要结局

mass-to-muscle mass ratio between M0 and M6

时间窗: Between baseline (M0) and month 6 (M6)

Change in the mass-to-muscle mass ratio between M0 and M6, measured at the end of the hemodialysis session using bioelectrical impedance analysis.

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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