Effect of Pulsed Electrmagnetic Field Versus Treadmill Training on Walking and Haemodynamic Parameters in Peripheral Arterial Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Ankle brachial pressure index ( ABPI )
研究概览
简要总结
my study is to determine the effect of pulsed electromagnetic field versus treadmill training in managemet of intemittent claudication in peripheral arterial disease
there is a lack of interventions that improves local peripheral blood circulation in ischemic lower limbs . (PEMFs) are a non-pharmacological and non-invasive treatment that can be applied on the affected body part, which penetrates through skin and reaches target tissues . However, there have been few clinical studies reporting the effects of PEMFs on hemodynamic response in people with PAD (
详细描述
Statement of the problem :
Is there any Difference between Pulsed ElectroMagnetic Field and Supervised Treadmill walking exercise on improving exercise performance and hemodynamic parameters in patients with peripheral arterial disease
The use of pulsed electromagnetic field (12hz to50hz) in improving microcirculation , microvascular blood perfusion , stimulation of nitric oxide release and stimulating angiogensis has introduced a new dimension to the physical therapy field , to the available knowledge puplished , there is no literature about analgesic and microcirculatory effect of PEMF on circulation improvement in patients with PAD , therefore the proplem of the study will be stated in a questionnary form for answering the following aspects : ( Chalidia B. etal 2011)
Significance of the study :
Treatment of PAD is critically important in order to minimize the risk of long term disability and improve quality of life . The need of this study developed from the lack in published studies about the effect of pulsed electromagnetic field in management of peripheral arterial diseases and also there was no available previous trials comparing the effect of PEMF and treadmill exercise on walking parameters , posterior tibial artery diameter and ABI on patients with PAD
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
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders are allowed to participate in the study .
- •The age range of patients will be from 45-65 years
- •All patients are diagnosed with PAD since at least ( 6 months to1 year) and suffer from IC
- •All patients will be suffering from moderate degree of pain in the calf according to claudication pain scale.
- •ABPI for all patients will be ranged from 0.65 to
- •All patients are medically and psycholigically stable .
- •Only ambulant patient without any aids will be selected
- •All patients are non smokers
排除标准
- •Patients with Severe grades of intermittent claudication that produce ischemic pain at rest
- •Presence of claudication symptoms less than 2 months
- •Patients with fontaine stage I PAD (asymptomatic)
- •Patient with fontaine stage III PAD (leg pain at rest )
- •Patients with ABPI ( Ankle Brachial Pressure Index ≤ 0.4 )
- •Patients who are unable to walk on the treadmill or unable to attend sessions at the physical therapy department at APH , 3 times a week .
- •Patients with unstable cardiovascular conditions (those with a known history of recent myocardial infarction, uncontrolled hypertension, ischemic attacks, stroke, congestive heart failure) will be excluded from this study.
- •Patients with neurological problems that cause leg pain .
- •Patients with active malignancy will be excluded from study Patients with acute tuberculosis, soft tissue infection, cellulities, hyperthyroidism, acute viral diseases, Patients with pace makers will be excluded from the study Patients with ischemic ulcers or gangrenes
- •Patients with marked dyspnea on exertion or with chronic obstructive pulmonary diseases (COPD).
- •Patients with a vascular surgical procedure or angioplasty within the previous year will be excluded from the study
- •Patients with musculoskeletal disorders ( Diagnosed with severe osteoporosis , severe osteoarthritis or joint replacement )
研究组 & 干预措施
pulsed electro magnetic field
30 patients will receive the physical therapy program in form of low frequency pulsed electro magnetic field application. with frequency 15hz, and low intensity with flux density of 20 Gauss (2mT), in pulse duration 200 usec , pulsed rectangular pulses for 60 min is applied to the dorsal surface of lower leg , ankle and foot in addition to their regular medications prescribed , 3 times per week for 8 week
干预措施: pulsed electromagnetic field (Device)
Treadmilltraining
- In this group, 30 patient will receive the physical therapy program in form of supervised treadmill walking exercise. The exercise program consists of intermittent walking bouts to moderate claudication pain alternating with periods of rest in between for a total of 40-50 minutes .
- At first , a 5 minutes- warm up period will be allowed, it will include stretching exercises for calf muscles , hamstrings and quadriceps (i.e. each for at least 10 -15 seconds) . Patients should start with walking on the treadmill at a comfortable speed, and should not stop at the onset of leg pain but instead , he/she would continue until moderate pain is reached. At this point, he/she has to rest until pain completely subsides, then walking is resumed again . The intensity of exercise will be determined by claudication pain scale, and should not exceed the score of 4 on this scale. The exercise can be progressed if the patient can walk continuously for 10 minutes without the need to stop.
干预措施: treadmill training (Other)
medications
It includes 20 patients who will not receive any physiotherapy intervention. They will receive medical treatment only and will act as a control group.
干预措施: Medication (Drug)
结局指标
主要结局
Ankle brachial pressure index ( ABPI )
时间窗: 8 weeks
it will be measured by doppler ultrasound
Posterior Tibial Artery Diameter ( PTA )
时间窗: 8 WEEKS
it will be measured by doppler ultrasound
次要结局
- claudication onset time (COT) or distance(8 WEEKS)
- a peak walking time (PWT) or peak walking distance.(8 WEEKS)
研究者
reham raafat mahmoud
REHAM RAAFAT
Cairo University