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Набор скоро начнётся NCT07319468

Effect of Exercises on Hemodialysis

Без фазы С лечением Hemodialytic Patients

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Aerobic exercises, Open kinetic chain active free range of motion, No intervention.
Кому может быть актуально
Состояния в реестре: Hemodialytic Patients. Базовые параметры: 50 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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.

II- Instrumentation 6-Minutes walk test: The 6-min walk test (6MWT) is frequently used to measure physical function in transplanted patients.

* Fatigue Questionnaire (Fatigue Severity Scale) it was used to assess the level of fatigue. * Laboratory investigation: urea and creatinine are commonly used to monitor the effects of exercise on urea clearance and kidney function improvement in transplant patients. * The Mini-Cog test: is a quick, simple, and effective screening tool for early cognitive impairment in hemodialysis patients, making it ideal for busy clinical settings.

B-Therapeutic Equipment:

Foot pedal exerciser (fig.9):

* Simple horizontal foot pedal exerciser used during hemodialysis sessions. * Dual pedals with non-slip straps for foot stability. * Manual resistance adjustment via a single control knob (non-electric). * Provides gradual increase in workload intensity. * Compact and light weight design suitable for use while lying on the dialysis bed. * Enables controlled, low-impact circular movement of the feet. * Aims to improve circulation and strengthen lower limb muscles without requiring active sitting. * Approximate device dimensions: 50 cm (length) x 40 cm (width) x 23 cm (height). * Maximum recommended user weight: 70 kg. Participants completed the 30-min aerobic exercise sessions during the first 2 hrs. of each dialysis session, 3 times per week for 8 weeks, using a simulated bike riding. Patients will perform active free exercise for upper limb (the arm that hasn't shunt) and lower limbs. Each exercise session consisted of three phases: warm up, conditioning, and cool down.

Вмешательства

  • Устройство Aerobic exercises
    Foot pedal exerciser: * Simple horizontal foot pedal exerciser used during hemodialysis sessions. * Dual pedals with non-slip straps for foot stability. * Manual resistance adjustment via a single control knob (non-electric). * Provides gradual increase in workload intensity. * Compact and light weight design suitable for use while lying on the dialysis bed. * Enables controlled, low-impact circular movement of the feet. * Aims to improve circulation and strengthen lower limb muscles without re
  • Другое Open kinetic chain active free range of motion
    Participants completed the 30-min aerobic exercise sessions during the first 2 hrs. of each dialysis session, 3 times per week for 8 weeks, using a simulated bike riding. Patients will perform active free exercise for upper limb (the arm that hasn't shunt) and lower limbs. Each exercise session consisted of three phases: warm up, conditioning, and cool down.
  • Другое No intervention
    the control group will receive only the standard medical care provided by dialysis center without any physical therapy intervention

Первичные конечные точки

  • Fatigue Questionnaire (Fatigue Severity Scale) [Срок оценки: 8 weeks]
  • 6-Minutes walk test [Срок оценки: 8 weeks]
Вторичные конечные точки (3)
  • Laboratory investigation (Urea analysis) [Срок оценки: 8 weeks]
  • The Mini-Cog test [Срок оценки: 8 weeks]
  • Laboratory investigation (creatinine analysis) [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07319468 · NO:P.T.R.EC/012/004902

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗