Pulmonary Functions in Sickle Cell Disease: Response of Adding Acu-TENS to Inspiratory Muscle Training
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- FEV1/FVC ratio
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •sickle cell disease patients
- •non obese patients
排除标准
- •patients with any systemic or chest or renal or hepatic or neurological diseases
- •women with lactation or pregnancy
- •patients atacks of vasoocclusive crisis
研究组 & 干预措施
group I
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 pulse duration.
干预措施: inspiratory muscle training and acupucnture like transcutanoeus electrical nerve stimulation (Behavioral)
Group II
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.
干预措施: inspiratory muscle training (Behavioral)
结局指标
主要结局
FEV1/FVC ratio
时间窗: it will be assessed after12 weeks
will be measured by spirometry
次要结局
- forced expiratory volume at the first second of expiration(it will be assessed after12 weeks)
- forced vital capacity(it will be assessed after12 weeks)
- six minute walk distance(it will be assessed after12 weeks)
- physical summary of short form 36(it will be assessed after12 weeks)
- mental summary of short form 36(it will be assessed after12 weeks)
- right diaphragmatic excrusion(it will be measured after 12 weeks)
- left diaphragmatic excrusion(it will be measured after 12 weeks)
研究者
Ali Mohamed Ali ismail
Department of Physical Therapy for Cardiovascular/Respiratory Disorder and Geriatrics, Faculty of Physical Therapy
Cairo University