Treadmill Training with TENS Impact on Walking Distance, Pain and Peak Velocity in Patients with Peripheral Arterial Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Doppler ultrasonography
研究概览
简要总结
Fifty patients from both sexes with PAD, stage II fontaine will participate in this study. Their ages will be from 40-75 years old. They will be selected from kasr el ainy (faculty of medicine), Cairo University, Giza, Egypt. The patients will be randomly assigned into two equal groups:
Group (A): 25 patients will receive transcutaneous electrical nerve stimulation (TENS) for 45 minutes per session applied on calf muscle, combined with treadmill three days per week for twelve weeks in addition to the routine medical treatment.
Group (B): 25 patients will receive treadmill training for 45 minutes per session, three days per week for twelve weeks in addition to the routine medical treatment
详细描述
Procedures of the study:
a) Evaluating procedures: It will be performed before treatment and 12 weeks after treatment program.
History and physical examination:
Complete history taking will be conducted to collect data about patient's general condition, current medication, measuring blood pressure, heart rate and physical activity.
Anthropometric measurement:
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Fifty patients who had intermittent claudication secondary to PAD
- •Ambulation during a graded treadmill test limited by leg pain consistent with intermittent claudication (stage II of the Fontaine classification of PAD)
- •Ankle-brachial index (ABI) of 0.90 or lower at rest or 0.73 or lower after exercise
- •Their age will be ranged from 40-75 years old
- •Body mass index (BMI) from 18.5 to 40 kg/m2
- •they are able to take part in an outpatient rehabilitation program
- •they are clinically stable
- •they are sedentary activity level according to Global Physical Activity Questionnaire (GPAQ).
排除标准
- •• Absence of PAD
- •Inability to obtain an ABI measure because of non compressible vessels
- •Asymptomatic PAD determined from the medical history and verified during the graded treadmill test
- •Use of cilostazol and pentoxifylline initiated within 3 months before the investigation
- •Exercise tolerance limited by factors other than leg pain
- •Active cancer, renal disease, or liver disease
- •The presence of a contraindication to the use of TENS, such as a pacemaker or skin lesion.
- •walking disorders related to orthopedic or neuromuscular disease
- •associated progressive disease causing deterioration in general health
- •implanted pacemaker or defibrillator
- •uncontrolled diabetes
研究组 & 干预措施
Treadmill with TENS training
SIDEA-Germany treadmill & MH8001 Portable tens Treadmill walking initially will begin exercising at 2 mph (3.2 km/h) at a 0% grade. They will walk until their claudication pain and determine site of pain then we will apply TENS on pain site and starting frequency at 2 HZ, then will increase inclination of treadmill gradually together with increasing frequancy of TENS up to 120 HZ if patient will report any feeling of pain, pain became moderately severe (4 of 5 on the claudication scale), throughout 45-minute exercise session. When a participant will be able to walk for 8 minutes at the initial workload without having to stop because of moderately severe claudication, the treadmill grade will be increased by increments of 0.5% until an 8-10% grade will be achieved. Subsequently, exercise intensity will be increased during training sessions by increasing the treadmill speed by increments of 0.1-0.2 mph (0.2-0.3 km/h) as tolerated
干预措施: TREADMILL(SIDEA-Germany treadmill ) with TENS (Other)
Treadmill training
Over the past 30 years, treadmill-based SET programs have been shown to be consistently beneficial in improving walking ability as assessed by graded treadmill testing and to be effective in patients with PAD both with and without classic symptoms of claudication. Treadmill-based exercise therapy for patients with PAD consists of intermittent bouts of walking exercise to moderate to moderately severe discomfort (4 of 5 on the claudication scale) followed by short periods of rest until symptoms resolve. These exercise/rest bouts are repeated over a 30- to 45-minute exercise session. Exercise capability is most commonly measured as COT/COD and PWT/PWD.
干预措施: TREADMILL(SIDEA-Germany treadmill ) with TENS (Other)
结局指标
主要结局
Doppler ultrasonography
时间窗: 12 weeks( three months)
Doppler ultrasonography: (a General Electric Logic P6 machine equipped with a linear probe with 7.5-12 MHz frequency and a curvilinear probe with 2.5-7.5 MHz frequency ) Duplex ultrasound (DUS) is an integral component of diagnostic testing for the evaluation and management of arterial disease. this technology, which combines the acquisition of blood flow (pulsed Doppler spectral analysis) and anatomic (B-mode and color Doppler imaging) ultrasonography has the advantage of non-invasively measuring blood flow velocity in a quick and continuous manner based on the velocity of sound. DUS rapidly expanded into peripheral arterial, visceral arterial, and peripheral venous applications, Duplex scanning will be performed by an experienced operator. APSV is the mean of the peak systolic velocities of the anterior and posterior tibial arteries (PTAs) measured at the ankle level.
次要结局
- The Walking Estimated Limitation Calculated by History (WELCH) questionnaire: to estimate walking capacity(12 weeks( three months))
- Maximal Treadmill Walking Time(12 weeks( three months))
- Ankle brachial pressure index (ABI)(12 weeks( three months))
- Skeletal muscle oxygen saturation (SmO2)(12 weeks( three months))
- Treadmill exercise testing(12 weeks( three months))
- Quality of Life questionnaire for patients with peripheral artery disease, QOLPAD(12 weeks( three months))
- Short-physical performance battery(12 weeks( three months))
研究者
Hadeer Kamal Abdelazim Hussein Elhashash
Assisstant lecturer of physical therapy for cardiovascular, respiratory and geriatrics
Cairo University