Clinical trial NCT04555876: Effect of High Tone External Muscle Stimulation on Peripheral Arterial Disease
Official title: High Tone External Muscle Stimulation On Endothelial Dysfunction And Walking Parameters In Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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.
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility criteria: 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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Primary outcomes:
measure: measuring walking time in minutes
timeFrame: 10 weeks
measure: measuring walking distance in meter
timeFrame: 10 weeks
Secondary outcomes:
measure: Measuring serum Nitric Oxide
timeFrame: 10 weeks
Other outcomes:
Locations:
Study officials:
References: