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Effect of High Tone External Muscle Stimulation on Peripheral Arterial Disease

Primary Purpose

Diabetic Peripheral Neuropathy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
high tone external muscle stimulation- stationary bicycle
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetic Peripheral Neuropathy

Eligibility Criteria

50 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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).

    -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    high tone external muscle stimulation

    stationary bicycle

    Arm Description

    - 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.

    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.

    Outcomes

    Primary Outcome Measures

    measuring walking time in minutes
    maximum walking time the patient can walk in minutes without complain
    measuring walking distance in meter
    maximum walking distance the patient can walk in meter

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    September 8, 2020
    Last Updated
    September 14, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04555876
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2020 (Anticipated)
    Primary Completion Date
    November 1, 2020 (Anticipated)
    Study Completion Date
    February 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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: 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetic Peripheral Neuropathy

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    Participant
    Masking 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.
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    high tone external muscle stimulation
    Arm Type
    Experimental
    Arm Description
    - 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.
    Arm Title
    stationary bicycle
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    high tone external muscle stimulation- stationary bicycle
    Other Intervention Name(s)
    stationary bicycle
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    measuring walking time in minutes
    Description
    maximum walking time the patient can walk in minutes without complain
    Time Frame
    10 weeks
    Title
    measuring walking distance in meter
    Description
    maximum walking distance the patient can walk in meter
    Time Frame
    10 weeks
    Secondary Outcome Measure Information:
    Title
    Measuring serum Nitric Oxide
    Description
    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.
    Time Frame
    10 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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: 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). -

    12. IPD Sharing Statement

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    Effect of High Tone External Muscle Stimulation on Peripheral Arterial Disease

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