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临床试验/NCT05534542
NCT05534542已完成不适用

Comparison of the Effectiveness of Intradialytic Core Stabilization and Aerobic Exercise in Hemodialysis Patients

Muş Alparslan University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年8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
已完成
入组人数
40
试验地点
1
主要终点
Kidney Disease Quality of Life-36 (KDQOL-36)

研究概览

简要总结

Purpose: To examine the effects of core stabilization and aerobic exercises on dialysis adequacy, functionality level, and quality of life in hemodialysis (HD) patients. The secondary aim of the study is to compare the effectiveness of intradialytic core stabilization and aerobic exercises in HD patients.

Materials and Methods: Patients who received hemodialysis treatment for 4 hours, 3 days a week were planned to be included in this randomized controlled study. Patients participating in the study will be randomly divided into 2 groups. Grup 1 was planned to be given core stabilization exercises during hemodialysis three times a week for eight weeks; Group 2 was planned to be given aerobic exercise during hemodialysis three times a week for eight weeks. It aimed to evaluate the patients in the weeks before the start of the treatment and the week after the end of the treatment. Personal information form for evaluation, dialysis adequacy, quality of life questionnaire-kidney disease quality of life-36, piper fatigue scale, hospital anxiety and depression scale (hads), Pittsburgh sleep scale, five times sit and stand test, 10 m walking test , tinetti balance and walking test, and 2-minute step test were planned to be used.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •To receive HD treatment for a minimum of 6 months, for 4 hours per day, three days per week
  • •Being 18 years or older
  • •A score of 3 and/or below in the Sarcopenia Screening Test (SARC-F)

排除标准

  • •Having a history of myocardial infarction in the last 3 months
  • •Having angina pectoris, arrhythmia, or uncontrolled hypertension
  • •Having communication and/or cognitive issues that prevent them from meeting the requirements of the tests
  • •Becoming pregnant or going through infertility treatment
  • •Having a psychiatric diagnosis

研究组 & 干预措施

core stabılızatıon

Active Comparator

use of ıntradıalıtıc core stabılızatıon ın hemodıalysıs patıents

干预措施: exercıse (Other)

aerobıc exercıse

Active Comparator

use of ıntradıalıtıc aerobıc exercıse ın hemodıalysıs patıents

干预措施: exercıse (Other)

结局指标

主要结局

Kidney Disease Quality of Life-36 (KDQOL-36)

时间窗: Two months

The KDQOL-36 is a measure of kidney disease-related quality of life that comprises four subscales: generic core \[Physical Component Summary (PCS, 12 items) and Mental Component Summary (MCS, 12 items)\]; Symptoms/Problems (12 items); Burden of Kidney Disease (4 items), and Effects of Kidney Disease (8 items).

10 Metre Walk Test

时间窗: Two months

The 10 meter walk test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.

Dialysis adequacy

时间窗: one month

Dialysis adequacy is determined as the urea reduction rate (URR) and unitless Kt/V value. In calculating the Kt/V value; K-is the urea clearance coefficient of the dialyzer (ml/min), t refers to dialysis time (min), and V signifies the urea distribution volume (ml).

2 Minute Step Test

时间窗: Two months

The test, known as the 2-minute step test (TMST), simply requires that tested individuals march in place as fast as possible for 2 minutes while lifting their knees to a height midway between their patella and iliac crest when standing.

Five times sit-to-stand test

时间窗: Two months

The Five-Times Sit to Stand Test measures one aspect of transfer skill. The test provides a method to quantify functional lower extremity strength and/or identify movement strategies a patient uses to complete transitional movements.

次要结局

  • Pittsburgh Sleep Quality Index (PSQI)(Two months)
  • Piper Fatigue Scale(Two months)
  • Hospital Anxiety and Depression Scale (HADS)(Two months)
  • Tinetti Gait and Balance Test(Two months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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