High Tone External Muscle Stimulation On Endothelial Dysfunction And Walking Parameters In Peripheral Arterial Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- measuring walking time in minutes
研究概览
简要总结
to investigate the effect of high tone external muscle stimulation (HTEMS) on endothelial dysfunction and walking parameters in peripheral vascular disease.
详细描述
The patients will randomly be divided into two equal groups in number:
- Group A :
Thirty patients will participate in physical therapy program in form of high-tone external muscle stimulation (HTEMS), with Frequencies continuously will be scanned from 4096 Hz to 31768 Hz, allowing for a much higher power of up to 5000 mW to be introduced 3 times per week, for 10 weeks plus supervised regular aerobic exercise program on stationary bicycle with moderate intensity, ( score 12-14 on Borg scale for rate of perceived exertion) 40 minutes per session, 3 times per week, for 10 weeks . 2. Group B:
Thirty patients will participate in a supervised regular aerobic exercise program only on stationary bicycle with moderate intensity, (score 12-14 on Borg scale for rate of perceived exertion) 40 minutes per session, 3 times per week, for 10 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
The patients will randomly be divided into two equal groups in number:
- Group A :
Thirty patients will participate in physical therapy program in form of high-tone external muscle stimulation (HTEMS), with Frequencies continuously will be scanned from 4096 Hz to 31768 Hz, allowing for a much higher power of up to 5000 mW to be introduced 3 times per week, for 10 weeks plus supervised regular aerobic exercise program on stationary bicycle with moderate intensity, ( score 12-14 on Borg scale for rate of perceived exertion) 40 minutes per session, 3 times per week, for 10 weeks . 2. Group B:
Thirty patients will participate in a supervised regular aerobic exercise program only on stationary bicycle with moderate intensity, (score 12-14 on Borg scale for rate of perceived exertion) 40 minutes per session, 3 times per week, for 10 weeks.
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
- •1- Both genders are allowed to participate in the study. 2- The age range of patients will be from 50-60 years 3- All patients are diabetic from 5-7 years. 4- ABPI for all patients will be ranged from 0.65 to
- •9 5- All patients are medically and psychologically stable. 6- Only ambulant patient without any aids will be selected 7- All patients are non smokers.
排除标准
- •Patients with ABPI ( Ankle Brachial Pressure Index ≤ 0.4 )
- •Patients who are unable to walk on treadmill or unable to attend sessions at the physical therapy department at Cairo university hospitals, 3 times a week.
- •Patients with unstable cardiovascular conditions (those with a known history of recent myocardial infarction, uncontrolled hypertension, ischemic attacks, stroke, and congestive heart failure) will be excluded from this study.
- •Patients with neurological problems that cause leg pain and polyneuropathy.
- •Patients with active malignancy will be excluded from study
- •Patients with ischemic ulcers or gangrenes
- •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
high tone external muscle stimulation
- HiTop 191 appliance (gbo Medizintechnik AG, Rimbach, Germany) Device HiToP® 4 touch gbo Medizintechnik AG, this modern high-tech design with brushed aluminum surface and the 15" TFT LC D full color touch screen monitor offer to the health care professional an indispensable feature.
干预措施: high tone external muscle stimulation- stationary bicycle (Device)
stationary bicycle
supervised regular aerobic exercise program on stationary bicycle with moderate intensity, (score 12-14 on Borg scale for rate of perceived exertion) 40 minutes per session, 3 times per week, for 10 weeks.
干预措施: high tone external muscle stimulation- stationary bicycle (Device)
结局指标
主要结局
measuring walking time in minutes
时间窗: 10 weeks
maximum walking time the patient can walk in minutes without complain
measuring walking distance in meter
时间窗: 10 weeks
maximum walking distance the patient can walk in meter
次要结局
- Measuring serum Nitric Oxide(10 weeks)
研究者
Rania Abdel Baset
principle invistigator
Cairo University
