跳至主要内容
临床试验/NCT07181746
NCT07181746尚未招募不适用

Effect of Pilates Exercises on Restless Leg Syndrome, Functional Capacity and Physical Self-perception Among Older Adult Undergoing Hemodialysis

Norther Private Collage of Nursing0 个研究点目标入组 100 人开始时间: 2025年10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
100
主要终点
change in severity level of restless leg syndrome

研究概览

简要总结

The study aimed to evaluate the effect of Pilates exercises on restless leg syndrome, functional capacity and physical self-perception among older adult undergoing hemodialysis. participants are 60 elderly patients both male and female who undergoing maintenance hemodialysis.

详细描述

The research hypothesis include : H1: Older Adult Undergoing Hemodialysis who will practice Pilates exercises will have less severity of the Restless Leg Syndrome, and high Functional Capacity and Physical Self-Perception than those who will not practice.

Participants were divided into two groups (study and control). Both groups were asked to fill out all questionnaires before and after the study using the same tools. In the control group, older adult receives routine care, which was provided by the hospital as examination, routine medication . Participants were asked to answer a post-test using the same pre-test questionnaires. And the study group were divided into small training groups with 3-5 older adult for each group.

研究设计

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

盲法说明

Non

入排标准

年龄范围
60 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Age of ≥ 65 years old,
  • A History of hemodialysis treatment two to three times per week for at least six months,
  • Interest in participation,
  • Being able to move independently and with a physical condition certified by a physician to play the sport, with no myocardial infarction or surgery in the past six months of the study.

排除标准

  • Three or more absences in exercise sessions;
  • Being a habitual Pilates practitioner;
  • Detection of reduced exercise tolerance, including tachycardia, shortness of breath, and feeling too tired or weak;
  • Peritoneal dialysis during the study; and other concurrent clinical conditions, such as cardio-respiratory problems reported by physician and/or patients

结局指标

主要结局

change in severity level of restless leg syndrome

时间窗: 3 month

Restless Leg Syndrome Rating Scale: used for assessing the severity restless legs syndrome (RLS). This tool composed of 10-item questionnaire asks respondents to use Likert-type ratings. Each question contains answers that score from 0 to 4 points, with 0 representing the absence of a problem and 4 representing a very severe problem. Total scores can range from 0 to 40. Questions can be divided into one of two categories: disorder symptoms (nature, intensity, and frequency) and their impact (sleep issues, disturbances in daily functioning, and resultant changes in mood). Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, Mild=1-10 points, None=0 points

change in severity level of restless leg syndrome

时间窗: 3 month

Restless Leg Syndrome Rating Scale: used for assessing the severity restless legs syndrome (RLS). This tool composed of 10-item questionnaire asks respondents to use Likert-type ratings. Each question contains answers that score from 0 to 4 points, with 0 representing the absence of a problem and 4 representing a very severe problem. Total scores can range from 0 to 40. Questions can be divided into one of two categories: disorder symptoms (nature, intensity, and frequency) and their impact (sleep issues, disturbances in daily functioning, and resultant changes in mood). Very severe=31-40 points, Severe=21-30 points, Moderate=11-20 points, Mild=1-10 points, None=0 points

次要结局

未报告次要终点

研究者

发起方
Norther Private Collage of Nursing
申办方类型
Other
责任方
Principal Investigator
主要研究者

Amal Hashem

Associate professor

Norther Private Collage of Nursing

相似试验