Pulmonary Functions in Sickle Cell Disease: Response to Acu-TENS

Официальное название

Pulmonary Functions in Sickle Cell Disease: Response of Adding Acu-TENS to Inspiratory Muscle Training

Обзор

pulmonary complications are common in sickle cell disease patients. Respiratory training using inspiratory muscle trainer (IMT) is usually a good choice to improve these complications. Recently, acupuncture like transcutaneous electrical nerve stimulation (AC-tens) may also improve these complications.

Подробное описание

sickle cell disease patients whose number will be forty patients will be divided to group I who will trained with IMT (threshold inspiratory muscle training) and treated with AC-tens (the number of patients will be 20) or group II who will trained with IMT (the number of patients will be 20) . The number of sessions per week will be three sessions for IMT or AC-tens for 12 weeks. the IMT will be performed for six sets of respiratory training cycles and the set will contain 10 respiratory cycles. Also the session of AC-tens will be 45 minute on bilateral Ex-B1 acupoint. the parameters of AC-tens will be four hertz and 200 microsecond pulse duration.

Вмешательства

• Поведенческое inspiratory muscle training and acupucnture like transcutanoeus electrical nerve stimulation
  sickle cell disease patients whose number will be 20 patients will be trained with IMT (threshold inspiratory muscle training) and treated with AC-tens. The number of sessions per week will be three sessions for IMT or AC-tens for 12 weeks. the IMT will be performed for six sets of respiratory training cycles and the set will contain 10 respiratory cycles. Also the session of AC-tens will be 45 minute on bilateral Ex-B1 acupoint. the parameters of AC-tens will be four hertz and 200 microsecond p
• Поведенческое inspiratory muscle training
  sickle cell disease patients whose number will be 20 patients who will trained with IMT (threshold inspiratory muscle training). The number of sessions per week will be three sessions for IMT for 12 weeks. the IMT will be performed for six sets of respiratory training cycles and the set will contain 10 respiratory cycles.

Первичные конечные точки

• FEV1/FVC ratio [Срок оценки: it will be assessed after12 weeks]

Вторичные конечные точки (7)

• forced expiratory volume at the first second of expiration [Срок оценки: it will be assessed after12 weeks]
• forced vital capacity [Срок оценки: it will be assessed after12 weeks]
• six minute walk distance [Срок оценки: it will be assessed after12 weeks]
• physical summary of short form 36 [Срок оценки: it will be assessed after12 weeks]
• mental summary of short form 36 [Срок оценки: it will be assessed after12 weeks]
• right diaphragmatic excrusion [Срок оценки: it will be measured after 12 weeks]
• left diaphragmatic excrusion [Срок оценки: it will be measured after 12 weeks]

Критерии участия

Критерии включения

• sickle cell disease patients
• non obese patients

Критерии исключения

• patients with any systemic or chest or renal or hepatic or neurological diseases
• women with lactation or pregnancy
• patients atacks of vasoocclusive crisis

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

Профилактика

Центры проведения

Египет · 1 центр

• faculty of physical therapy Cairo university — Dokki

Идентификаторы

NCT: NCT06757829 · IRB00014233-17

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗