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临床试验/NCT05889130
NCT05889130已完成不适用

What Is the Optimal Timing for Intradialytic Resistance Exercise? A Randomized Controlled Trial

Muş Alparslan University4 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2023年5月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
4
主要终点
systolic and diastolic blood pressure will be measured

研究概览

简要总结

The study consists of two groups doing resistance exercise for the first and last two hours of the HD session. The investigators are planning to form the sample size of exercise training from 40 participants, which the investigators determined according to the power analysis the investigators have done based on the blood pressure outcome criterion. Participants who meet the inclusion criteria the investigators have set will be divided into two groups. A resistance exercise training will be given three days a week for eight weeks, with a total of 24 sessions. The number of IRCAs occurring in both groups and blood pressure values to be measured at the beginning and end of the HD session will be checked, and both parameters will be compared between the groups before and after the treatment after 8 weeks of training. Thus, the investigators aim to show how the time factor has an effect on blood pressure. In addition, muscle strength, physical performance and quality of life of participants before and after resistance exercise will be evaluated and compared between groups. The participants' blood pressure will be evaluated with a conventional cuffed sphygmomanometer, muscle strength, digital hand dynamometer, physical performance, Short Physical Performance Battery and Timed Up and Go Test, and their quality of life will be evaluated with the Kidney Disease Quality of Life-36 (KDQOL-36) quality of life questionnaire. In exercise training, sandbags will be used as resistance. In our study, which the investigators planned as a randomized controlled trial, stratified randomization method will be used to distribute the gender factor homogeneously in both groups.

详细描述

Purpose and Objective: The aim of our study is to examine the effect of intradialytic (IR) resistance exercise time on blood pressure, physical performance and quality of life in hemodialysis (HD) patients. With this study we are planning to do, we aim to help HD patients regulate their blood pressure values and increase their muscle strength so that they can be more independent in their daily living activities and thus improve their quality of life.

Original Value: HD is the reorganization of the fluid and solute content of the blood taken from the patient by means of a membrane and with the help of a machine. The treatment requirements of HD patients (the HD session is usually applied two or three days a week and each application takes about 4 hours, as well as the plasma withdrawal from the body during HD) and long-term immobilization usually cause low blood pressure. This may cause some patients to have an intradialytic hypotensive attack (IDHA) due to the excessive decrease in blood pressure during HD. IDHA, on the other hand, is associated with severe abdominal pain, nausea, vomiting, dizziness, blackout, muscle cramps, with a decrease in systolic blood pressure of more than 20 mmHg compared to the predialysis (pre-dialysis) value or a decrease in mean systolic pressure of more than 10 mmHg from the predialysis value. It is defined as the coexistence of symptoms such as cramps and severe anxiety.

It is a known fact that regular exercises have a blood pressure lowering effect in the chronic period, and it is observed that exercises performed regardless of type (aerobic, resistant or combined) increase blood pressure in the acute period. Because blood flow is restricted due to the increase in pressure in the muscle during exercise, metabaroreceptors and mechanoreceptors in the active muscle stimulate the cardiovascular center in the medulla, and both systolic and diastolic pressure increase in order to exclude intramuscular pressure and provide perfusion. This is a response of the body to exercise and occurs as a result of normal physiological mechanisms.

Due to theoretical concerns that the exercise applied in the last two hours of the HD session may exacerbate hemodynamic instability, it is generally recommended to exercise in the first two hours of HD. However, there is also evidence showing that exercise can be done in the last two hours of the HD session. The increase in these evidences, especially in recent years, reveals that there is a need for studies on the effectiveness and reliability of IR exercise application time. The tendency of the blood pressure to drop more in the last half of the HD session (due to the increase in the amount of plasma withdrawn from the patients as time progresses) suggests that an exercise program that can be given in these minutes may provide a significant benefit to the patients, considering the acute blood pressure-raising effect.

From another point of view, studies show that resistance exercises (because it increases intramuscular pressure more) increase blood pressure more in the acute period than aerobic exercises. There are limited studies comparing the effects of aerobic and resistance exercises on blood pressure in HD patients. Limited existing studies have also revealed that resistance exercise raises blood pressure more than aerobic exercise in the acute period in HD patients. Therefore, it is thought that it would be more beneficial to include resistant exercises in the exercise program to be given to the patients in the last two hours.

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 (Outcomes Assessor)

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

  • Have been on HD treatment for at least 6 months
  • To be receiving HD treatment for 4 hours 3 days a week
  • 18 to 90 years old

排除标准

  • Having angina pectoris or uncontrolled arrhythmia and uncontrolled hypertension
  • Having communication or cognitive problems at a level that cannot fulfill the requirements of the tests
  • Having an orthopedic problem that cannot do the exercise
  • Have upcoming travel or kidney transplant plans
  • Having an intradialytic hypotensive attack in 3 consecutive sessions

结局指标

主要结局

systolic and diastolic blood pressure will be measured

时间窗: Change from baseline and 8 weeks systolic and diastolic blood pressure

次要结局

  • Kidney Disease Quality of Life-36(baseline and 8 weeks)
  • The Short Physical Performance Battery Scale(baseline and 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ömer Bingölbali

Lecturer

Muş Alparslan University

研究点 (4)

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