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临床试验/NCT02832440
NCT02832440已完成不适用

Comparison of Intradialytic Versus Home-based Programmes on Adherence and Strength of Stage 5 Chronic Kidney Disease Patients

Cardenal Herrera University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Change from Baseline Handgrip Strength at 4 months

研究概览

简要总结

Although exercise training of haemodialysis patients is associated with generally positive outcomes few haemodialysis units routinely offer intradialytic exercise therapy. This is often related to financial cost and/or staffing limitations. Home-based programs could be an alternative means of providing exercise benefits without associated implementation costs The aim of this study was to compare the effects of 4 weeks intradialytic versus home based exercise for haemodialysis patients regarding adherence and strength gains.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • people under hemodialysis treatment at least 3 months
  • be medicable stable
  • complete all the physical tests

排除标准

  • heart stroke in the previous 6 weeks of the study
  • inferior limb amputation without artificial aids
  • cerebral vascular disease (ictus, ischemic)
  • disability to complete functional tests

结局指标

主要结局

Change from Baseline Handgrip Strength at 4 months

时间窗: At the beginning and after 4 months

To measure the amount of strength developed by each hand in kg

Change from Baseline Short Physical Performance Battery at 4 months

时间窗: At the beginning and after 4 months

Assess lower extremity, which includes objective performance-based measure of balance (side-by-side, semi-tandem and tandem), endurance (4m gait speed) and strength (five chair stands). Each component was scored from 0 to 4 and when summed yielded Short Physical Performance Battery scores between 0 (poor) and 12 (best).

Change from Baseline Timed Up and Go test at 4 months

时间窗: At the beginning and after 4 months

To stand up from a standard arms chair, walk 3 meters, turn back the cone walk back and sit down to the chair. The time in seconds is record.

Change from Baseline Six minutes walking test at 4 months

时间窗: At the beginning and after 4 months

To walk the longest distance possible in 6 minutes by walking continuously the 20 or 30 metres indicated on the floor. It measures the distance in meters

Change from Baseline One leg standing test at 4 months

时间窗: At the beginning and after 4 months

Consist in maintain one leg stance for as long as possible. The test was considered normal if the one leg standing time reached 45 seconds.

Change from Baseline Sit to stand to sit 10 and 60 at 4 months

时间窗: At the beginning and after 4 months

For the Sit To Stand 10 participant has to stand up and sit down 10 times and the time needed is record; while for the Sit to stand to sit 60 the participant consist in measures how many repetition the participant can to stand up and sit down during 60 seconds

Change from Baseline One leg heel rise at 4 months

时间窗: At the beginning and after 4 months

It measures the strength in the triceps surae in the one leg standing position and has to rise the heel. It measures how many repetitions the participants is can do

次要结局

未报告次要终点

研究者

发起方
Cardenal Herrera University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eva Segura Ortí

Professor

Cardenal Herrera University

研究点 (2)

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