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临床试验/NCT04555876
NCT04555876Unknown不适用

High Tone External Muscle Stimulation On Endothelial Dysfunction And Walking Parameters In Peripheral Arterial Disease

Cairo University0 个研究点目标入组 60 人开始时间: 2020年11月1日最近更新:
适应症
干预措施

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:

  1. 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:

  1. 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

Experimental
  • 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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rania Abdel Baset

principle invistigator

Cairo University

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