Correlation Between Selected Hematological and Doppler Ultrasonic Parameters After Electrical Stimulation in Peripheral Arterial Diseased Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Arterial diameter
研究概览
简要总结
Forty patients of both sexes, aged between 50 and 60 years, were chosen from an outpatient vascular clinic in the El Sahel Education Hospital. Patients have been examined and referred to by a vascular specialist.
详细描述
The participants were divided randomly into two groups of equal numbers. The study group got low-frequency TENS (4 Hz frequency, pulse duration 200 μs) which was administered through surface electrodes for 45 min per session, supramaximal stimulation for T12, L1, and L2 sympathetic ganglions that innervate the lower extremity for 45 min per session, three times per week and for 12 weeks. Control Group that received placebo stimulation as provided by the same TENS device but with a zero volt after 10 s of stimulation.
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
- 50 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral Leriche-Fontaine stage-II PAD
- •Aged 50 to 60 years
- •Outpatients
- •Clinically stable
- •Not participating in any physical activity last 3 months
排除标准
- •Walking disorders related to orthopedic or neuromuscular disease
- •Renal insufficiency requiring dialysis (Renal diseases)
- •Known and documented myopathy
- •Progressive cancer
- •Associated progressive disease causing a deterioration in general health
- •Participation in another research protocol
- •Skin disorder making it impossible to use TENS
- •Absolute contraindication to physical activity
- •Presence of a pacemaker/defibrillator
研究组 & 干预措施
study group(A)
Group (A) included 20 patients who received low-frequency TENS (frequency 4 Hz, pulse duration 200 μs) for 45 min per session, three times per week, and for 12 weeks.
干预措施: Transcutaneous Electrical Nerve Stimulation(TENS) device (Device)
Control group(B)
The control group(B) included 20 patients who received placebo TENS stimulation but with a voltage level falling to zero after 10 s of stimulation
干预措施: Transcutaneous Electrical Nerve Stimulation(TENS) device (Device)
结局指标
主要结局
Arterial diameter
时间窗: change from baseline to after 12 weeks
Diameter of lower limb arteries measured by doppler ultrasonography
Mean platelet volume(MPV)
时间窗: change from baseline to after 12 weeks
Peripheral venous blood samples were obtained from each patient.
Ankle peak systolic velocity (APSV)
时间窗: change from baseline to after 12 weeks
is the mean of the peak systolic velocities of the anterior and posterior tibial arteries measured at the ankle level by doppler ultrasonography
Red cell distribution width (RDW)
时间窗: change from baseline to after 12 weeks
Peripheral venous blood samples were obtained from each patient.
次要结局
- Actual claudication distance(change from baseline to after 12 weeks)
研究者
Heba Ahmed Ali Abdeen
Assistant professor
Cairo University