Effect of High Tone External Muscle Stimulation on Peripheral Arterial Disease

NCT04555876 | Unknown

• 1 other identifier: P.T.REC/012/002173
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Measuring serum Nitric Oxide

  10 weeks

Study Arms (2)

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.

Device: high tone external muscle stimulation- stationary bicycle

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.

Device: high tone external muscle stimulation- stationary bicycle

Interventions

high tone external muscle stimulation- stationary bicycle DEVICE

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

Also known as: stationary bicycle

high tone external muscle stimulation; stationary bicycle

Eligibility Criteria

• Age: 50 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle invistigator

Model Details: 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 Record Dates

• First Submitted: September 8, 2020
• First Posted: September 21, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: February 1, 2021
• Last Updated: September 21, 2020

Record last verified: 2020-09