Effect of High Tone External Muscle Stimulation on Peripheral Arterial Disease

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

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

Study Overview

• Status: Unknown
• Conditions: Diabetic Peripheral Neuropathy
• Intervention / Treatment: Device: high tone external muscle stimulation- stationary bicycle

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

1. Patients with ABPI ( Ankle Brachial Pressure Index ≤ 0.4 )
2. 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.
3. 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.
4. Patients with neurological problems that cause leg pain and polyneuropathy.
5. Patients with active malignancy will be excluded from study
6. Patients with ischemic ulcers or gangrenes
7. Patients with a vascular surgical procedure or angioplasty within the previous year will be excluded from the study

8. Patients with musculoskeletal disorders (Diagnosed with severe osteoporosis, severe osteoarthritis or joint replacement).

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: high tone external muscle stimulation- stationary bicycle; 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; Other Names: stationary bicycle
Experimental: 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.	Device: high tone external muscle stimulation- stationary bicycle; 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; Other Names: stationary bicycle

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): February 1, 2021

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (Actual): September 21, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2020
• Last Update Submitted That Met QC Criteria: September 14, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Neuromuscular Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: P.T.REC/012/002173

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No