Electrical Stimulation for Respiratory and Leg Muscles Impact on Pulmonary Function and Leg Restless Syndrome in COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- dynamic gait index
研究概览
简要总结
Electrical neuromuscular stimulation electrode patches will be applied over the intercostal respiratory muscles and leg muscles In addition to conventional pulmonary rehabilitation
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
experimental group
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 bilateral, 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
干预措施: experimental group (Device)
control group
control group: placebo NMES at the same points in addition to the same conventional pulmonary rehabilitation program
干预措施: control group (Device)
结局指标
主要结局
dynamic gait index
时间窗: 10 weeks
It will be measured by dynamic gait index which includes eight items, walking on level surfaces, changing speeds, head turns in horizontal and vertical directions, walking and turning 180 degrees to stop, stepping over and around obstacles, and stair ascent and descent. Each item is scored on a scale of 0 to 3, with 3 indicating normal performance and 0 representing severe impairment. The best possible score on the DGI is a 24
次要结局
- pulmonary functions(10 weeks)
- Dyspnea(10 weeks)
- International restless leg syndrome questionnaire(10 weeks)
- visual analogue scale(10 weeks)
- Sleep quality(10 weeks)
- Chronic Respiratory Disease Questionnaire(10 weeks)
研究者
marwa mahmoud elsayed mahmoud
Assistant Professor
Cairo University