Electrical Stimulation for Respiratory and Leg Muscles Impact on COPD Patients

Официальное название

Electrical Stimulation for Respiratory and Leg Muscles Impact on Pulmonary Function and Leg Restless Syndrome in COPD Patients

Обзор

Electrical neuromuscular stimulation electrode patches will be applied over the intercostal respiratory muscles and leg muscles In addition to conventional pulmonary rehabilitation

Подробное описание

Intervention group: active NMES (350 μs pulses - 50 Hz frequency) will be applied at the lower third of the thigh, just above the patella, and the proximal electrode 5-10 cm below the anterior superior iliac spine for quadriceps muscle stimulation, and for intercostal muscles stimulation, NMES will be bilaterally, parallel to the ribs, in the intercostal space. The proximal electrode will be positioned close to the sternum, and the distal electrode laterally, close to the midaxillary line. In addition to conventional pulmonary rehabilitation program that comprised diaphragmatic and pursed lips breathing.

control group: placebo NMES at the same points in addition to the same conventional pulmonary rehabilitation program

Вмешательства

• Устройство experimental group
  Electrical neuromuscular stimulation electrode patches will be applied over the intercostal respiratory muscles and leg muscles (placed superficially just below each knee, over the head of the fibula, in close proximity to the common peroneal nerve).
• Устройство control group
  Placebo electrical neuromuscular stimulation electrode patches will be applied over the intercostal respiratory muscles and leg muscles (placed superficially just below each knee, over the head of the fibula, in close proximity to the common peroneal nerve).

Первичные конечные точки

• dynamic gait index [Срок оценки: 10 weeks]

Вторичные конечные точки (6)

• pulmonary functions [Срок оценки: 10 weeks]
• Dyspnea [Срок оценки: 10 weeks]
• International restless leg syndrome questionnaire [Срок оценки: 10 weeks]
• visual analogue scale [Срок оценки: 10 weeks]
• Sleep quality [Срок оценки: 10 weeks]
• Chronic Respiratory Disease Questionnaire [Срок оценки: 10 weeks]

Критерии участия

Критерии включения

• Patient undergoes four main clinical criteria for the diagnosis of RLS according to the international restless leg syndrome study group (IRLSSG) including

• an urge to move legs that is usually associated with paresthesia.
• alleviation of the symptoms by moving the legs.
• aggravation or exacerbation of the symptoms particularly at rest or during sitting or lying down in the bed.
• worsening of the signs at night. patients with diagnosed with grade I and grade II COPD their ages ranged between 45-55 o All patients will be clinically and medically stable when attending the study

Критерии исключения

• History of Deep venous thrombosis

• History of Bleeding disorders
• Have an implantable device like a pacemaker
• Recent Infected wound
• History of allergic response to the electrodes, gel or tape
• patients who participating in any other exercise program
• Loss of sensation or numbness

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

Египет · 1 центр

• Faculty of Physical Therapy — Dokki

Идентификаторы

NCT: NCT06670443 · P.T.REC/012/005638

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗