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Набор скоро начнётся NCT07679425

Effect of Pneumatic Compression on Diaphragmatic Excursion in Hemodialysis Patients With Low Back Dysfunction

Без фазы С лечением Low Back Disorder

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: Pneumatic compression device, Inspiratory muscle Trainer.
Кому может быть актуально
Состояния в реестре: Low Back Disorder. Базовые параметры: 40 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
Египет
Следующий шаг
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Обзор

This study will be conducted to investigate any significant effect of pneumatic compression on diaphragmatic excursion in patients with low back dysfunction .

Подробное описание

The prevalence of the musculoskeletal manifestations is high (76.4%) in the hemodialysis population .Pain is the most frequently reported symptom (44.9%). Seven studies (28%) reported back pain With a prevalence ranging from 14.29%-52%. In hemodialysis patients, Low back pain (LBP) can be attributed to sedentary lifestyle ،low physical performance, muscular weakness ،psychological factors, altered metabolic activity of the bones and joints, and rare causes such as tumor, spinal infection, and osteoporotic fractures.

Diaphragm is an important component of spine lumbar stability. In presence of low back pain ،there may be some alterations in this muscle like other muscles that are responsible for lumbar stabilization. Respiratory muscle training (RMT) has been proven to reduce pain intensity and improve respiratory muscle strength, physical function, balance, and consequently، the overall quality of life in several population groups.

Pneumatic compression device had a significant improvement in pulmonary functions and inspiratory muscle training. And pneumatic compression can be considered as an effective component for pulmonary rehabilitation in chronic obstructive pulmonary lung disease. patients. Up to investigated knowledge, No previous studies conducted to explore the effect of pneumatic compression versus Inspiratory muscle training on diaphragmatic function in patients with low back dysfunction .

Вмешательства

  • Устройство Pneumatic compression device
    Training program in the form of resisted inspiratory exercises using pneumatic compression device with abdominal sleeve on the top portion of the abdominal cavity beneath the xiphoid process. The patient used a pursed-lip breathing method to exhale after inhaling slowly through the nose such that the stomach slid out against the abdominal sleeve of the device. For 12 weeks, three times per week, the workout consisted of 10 sets with 4-5 breaths in each set and a rest period of 2-3 minutes.
  • Устройство Inspiratory muscle Trainer
    the subject underwent training in the form of six sets of five deep breaths against the trainer, with 1-2 minutes of rest in between sessions. Depending on their rate of perceived exertion, the patient determined the maximum training load at which they could effectively perform 10 breaths at maximum resistance. A load equivalent to 30% of the patient's maximum inspiratory effort was used to begin the training .This unique load gradually increased as the inspiratory muscle got stronger. At the co

Первичные конечные точки

  • Diaphragmatic excursion [Срок оценки: 12 weeks]
  • Pain intensity [Срок оценки: 12 weeks]
  • functional capacity [Срок оценки: 12 weeks]
Вторичные конечные точки (2)
  • Functional disability [Срок оценки: 12 weeks]
  • Health-related Quality of life [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

  • Patients have been on regular hemodialysis (three sessions a week) at least 6 months before the start of the study
  • Patients 'Age between 40 and 60 years old
  • Patients have not participated in any physical activity program at least 6 months before the start of the study
  • Patients have chronic back pain > 3months
  • Patients has non specific low back pain
  • Body mass index (BMI) from 25 to 34.9 kg/m2.
  • Patients are clinically and medically stable

Критерии исключения

  • Instability of patient's medical condition
  • Patients with chest infection
  • Inability to comprehend and follow instructions as in dementia or speech problems such as dysphasia,
  • uncontrolled diabetes mellitus,
  • Persistent systolic Blood Pressure (BP) greater than 200 mmHg, persistent diastolic BP greater than 120 mmHg
  • Chronic lung disease which result in significant oxygen desaturation on exercise or pulmonary congestion
  • Patients with lupus nephritis.
  • Patients with Spondylodiscitis , Compression fracture, Spinal stenosis

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
  • Hagar Atif Azab — Cairo

Идентификаторы

NCT: NCT07679425 · P.T.REC/012/005447

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗