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Набор скоро начнётся NCT07276828

Effect of Autogenic Training on Hemodialysis Patients

Без фазы С лечением Hemodialysis Patient Restless Leg Syndrome (RLS) Fatigue Sleep Disturbance

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: Autogenic training, conventional physical therapy and hemodialysis care.
Кому может быть актуально
Состояния в реестре: Hemodialysis Patient, Restless Leg Syndrome (RLS), Fatigue, Sleep Disturbance. Базовые параметры: 45 лет — 55 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
Египет
Следующий шаг
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Официальное название

Effect Of Autogenic Training On Restless Leg Syndrome And Sleep Disturbance In Hemodialysis

Обзор

goal of this interventional study to investigate the effect of autogenic training on sleep disturbance , restless leg syndrome and fatigue on hemodialysis patient Is there any significant effect of autogenic training on restless leg syndrome, sleep disturbance and fatigue in patients with hemodialysis? The intervention will include structured autogenic training sessions, and outcomes such as sleep quality and RLS severity and fatigue will be evaluated after 8 weeks of autogenic training on hemodialysis patients .

Подробное описание

Hemodialysis patients always face various problems such as fatigue and sleep disturbance due to the chronic nature and side effects of hemodialysis, which negatively affect their quality of life A variety of treatment regimens can be chosen to initially relieve symptoms of patients currently with RLS and fatigue, among available regimes, pharmacological treatments are mainly selected for cases with severe RLS, which, at times, lead to serious complications It is hypothesized that these patients, according to the above implications, require a treatment suitable to their somatopsychic necessity, that autogenic training should perform being a method of choice for these types of issues Few clinical trials have examined the efficacy of autogenic training in patients undergoing hemodialysis that suffering from fatigue, restless syndrome and sleep disturbance, this approach could be incorporated into routine care protocols, enhancing patient comfort, promoting self-management, and reducing reliance on medications and their complications.

Вмешательства

  • Поведенческое Autogenic training
    The Autogenic Training Program is a standardized mind-body relaxation technique that uses self-induced verbal formulas and passive concentration to promote autonomic regulation. The intervention includes guided sessions with 6 main exercises , The first exercise aims to relax muscles by repeating a verbal formula, "my right arm is heavy," emphasising heaviness. then feeling warm, initiated by the instruction ''my right arm is warm'', followed by cardiac activity using the formula ''my heartbeat
  • Другое conventional physical therapy and hemodialysis care
    control group will receive a conventional physiotherapy program that includes stretching exercises, strengthening exercises, range-of-motion training, and standard therapeutic procedures routinely used for patients with similar conditions. The sessions will follow a structured protocol delivered by a physiotherapist, without including any relaxation or autogenic training components.

Первичные конечные точки

  • Dialysis adequacy [Срок оценки: 8 weeks]
Вторичные конечные точки (3)
  • sleep disturbance [Срок оценки: 8 weeks]
  • restless leg syndrome [Срок оценки: 8 weeks]
  • fatigue [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

  • Age between 45 and 55 years.
  • Body Mass Index (BMI) between 25.0 and 29.9 kg/m².
  • Clinically and medically stable.
  • On hemodialysis for at least 6 months prior to enrollment.
  • Diagnosed with chronic kidney disease (CKD), defined by one or more of the following:

Evidence of kidney damage (e.g., albuminuria), or

Decreased kidney function with glomerular filtration rate (GFR) < 60 mL/min/1.73 m² for ≥ 3 months, irrespective of clinical diagnosis.

\*Systolic blood pressure < 140 mmHg, diastolic blood pressure < 90 mmHg, and heart rate < 80 bpm.

Критерии исключения

Uncontrolled pulmonary disease.

Severe vascular complications (e.g., critical limb ischemia).

Unstable angina.

Uncontrolled cardiac arrhythmia.

Decompensated heart failure.

Cognitive impairment.

Participants who miss more than two weeks of the program or request termination.

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
Простое слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Faculity of physical therapy — Cairo

Идентификаторы

NCT: NCT07276828 · P.T.REC/012/006063

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗