Effect of High Tone External Muscle Stimulation on Peripheral Arterial Disease

Study Overview
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Brief Summary
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to investigate the effect of high tone external muscle stimulation (HTEMS) on endothelial dysfunction and walking parameters in peripheral vascular disease.

Detailed Description
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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 . 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.

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

Conditions
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Diabetic Peripheral Neuropathy

Intervention / Treatment
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* Device: high tone external muscle stimulation- stationary bicycle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 0. 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. Exclusion Criteria: 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). -

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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 . 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high tone external muscle stimulation<br>- 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. | Device: high tone external muscle stimulation- stationary bicycle<br>* 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<br>* Other names: stationary bicycle;|
| Experimental: stationary bicycle<br>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. | Device: high tone external muscle stimulation- stationary bicycle<br>* 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<br>* Other names: stationary bicycle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measuring walking time in minutes | maximum walking time the patient can walk in minutes without complain | 10 weeks | 
| measuring walking distance in meter | maximum walking distance the patient can walk in meter | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring serum Nitric Oxide | Three millimeter of venous blood will be drawn from the anticubital vein of each patient before conduction and after completion of the study. Blood sample will be drawn for Nitric Oxide (NO) measurement. | 10 weeks |