Effect of High Tone External Muscle Stimulation on Peripheral Arterial Disease

Diabetic Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04555876
• Other study ID #: P.T.REC/012/002173
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: September 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: February 1, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 60 Years

Eligibility

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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Related Conditions & MeSH terms

• Diabetic Peripheral Neuropathy
• Peripheral Arterial Disease
• Peripheral Nervous System Diseases
• Peripheral Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measuring walking time in minutes	maximum walking time the patient can walk in minutes without complain	10 weeks
Primary	measuring walking distance in meter	maximum walking distance the patient can walk in meter	10 weeks
Secondary	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