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临床试验/NCT07319468
NCT07319468尚未招募不适用

Effect of Intra Dialytic Aerobic Exercises Versus Active Free Exercises on Cognitive Function and Functional Capacity in Hemodialytic Patients

Cairo University0 个研究点目标入组 69 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
69
主要终点
6-Minutes walk test

研究概览

简要总结

o Sixty-nine adult patients from both sexes. They were suffering from ESRD on maintenance hemodialysis, their age ranged from50-60 years old were selected from hemodialysis unit at Itay El Baroud central hospital. They were referred by the physician.

详细描述

Ⅰ-Subjects:

o Sixty-nine adult patients from both sexes. They were suffering from ESRD on maintenance hemodialysis, their age ranged from50-60 years old were selected from hemodialysis unit at Itay El Baroud central hospital. They were referred by the physician.

Study group (A): the study group consisted of (23) patients who received aerobic exercise in form of (foot pedal exerciser) for 20 Minutes for each session, 3 sessions per week, for 8 weeks plus maintain on their medical treatment and hemodialysis.

Study group (B): the study group consisted of (23) who received active free range of motion exercise (open kinetic chain active free range of motion) for 20 minutes for each session, 3 sessions per week, for 8 weeks plus maintain on their medical treatment and hemodialysis.

Control group (C): the control group consisted of (23) patients who were maintained on their medical treatment and hemodialysis.

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
Double (Participant, Investigator)

入排标准

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

入选标准

  • All patients were included according to the following criteria:
  • Age between 50-60years.
  • The patients had been on hemodialysis for at least 3 months with three sessions per week for 3-4hr per session.
  • The patients were diagnosed with end stage renal failure (stage5 CKD) on maintenance regular HD (three sessions/week (on alternate days), for four hours/session) for more than three months. (Receiving HD through uncomplicated arm arteriovenous (A-V) fistula
  • Under medical control
  • Both men and women were enrolled
  • Body math index ranged from 18,5- 24.9 kg/m²

排除标准

  • Patients who experienced or had one or more of the following were excluded from the study:
  • Patients with resting systolic blood pressure >200 mmHg and/or diastolic blood pressure >120 mmHg.
  • patients with neurological problems (e.g. stroke, head injury)
  • patients with musculoskeletal problems (e.g. sever osteoarthritis or difficulties in ambulation)
  • Patients with uncontrolled pulmonary disease. (e.g. exaggerated chronic obstructive pulmonary disease, acute asthma)
  • Patients with mental health problems and cognitive impairment due to inability to teach them how to make respiratory training.
  • Any patient who missed more than two weeks of the program or want to terminate the program.
  • Severe obesity (BMI >35)
  • Presence of malignant disease.
  • Patients with unstable angina, uncontrolled cardiac arrhythmia, decompensated heart failure, acute pericarditis or myocarditis.
  • The patients had hearing impairment or mental disorders.

结局指标

主要结局

6-Minutes walk test

时间窗: 8 weeks

The 6-min walk test (6MWT) is frequently used to measure physical function in transplanted patients

Fatigue Questionnaire (Fatigue Severity Scale)

时间窗: 8 weeks

The Fatigue Severity Scale it used to assess the level of fatigue. The Fatigue Severity Scale scores range from 9 to 36 where higher scores indicate worse fatigue and lower scores indicate improvement in fatigue.

次要结局

  • The Mini-Cog test(8 weeks)
  • Laboratory investigation (Urea analysis)(8 weeks)
  • Laboratory investigation (creatinine analysis)(8 weeks)

研究者

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

Faten Mahmoud

Consultant of Physical Therapy, Chest Hospital, Damanhour, Elbeheira

Cairo University

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