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Pulsed Electromagnetic Field Versus Treadmill Walking in Peripheral Arterial Disease

Primary Purpose

Peripheral Arterial Disease

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pulsed electromagnetic field
treadmill training
Medication
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Both genders are allowed to participate in the study .
  • The age range of patients will be from 45-65 years
  • All patients are diagnosed with PAD since at least ( 6 months to1 year) and suffer from IC
  • All patients will be suffering from moderate degree of pain in the calf according to claudication pain scale.
  • ABPI for all patients will be ranged from 0.65 to 0. 9
  • All patients are medically and psycholigically stable .
  • Only ambulant patient without any aids will be selected
  • All patients are non smokers

Exclusion Criteria:

  • Patients with Severe grades of intermittent claudication that produce ischemic pain at rest
  • Presence of claudication symptoms less than 2 months
  • Patients with fontaine stage I PAD (asymptomatic)
  • Patient with fontaine stage III PAD (leg pain at rest )
  • Patients with ABPI ( Ankle Brachial Pressure Index ≤ 0.4 )
  • Patients who are unable to walk on the treadmill or unable to attend sessions at the physical therapy department at APH , 3 times a week .
  • Patients with unstable cardiovascular conditions (those with a known history of recent myocardial infarction, uncontrolled hypertension, ischemic attacks, stroke, congestive heart failure) will be excluded from this study.
  • Patients with neurological problems that cause leg pain .
  • Patients with active malignancy will be excluded from study Patients with acute tuberculosis, soft tissue infection, cellulities, hyperthyroidism, acute viral diseases, Patients with pace makers will be excluded from the study Patients with ischemic ulcers or gangrenes
  • Patients with marked dyspnea on exertion or with chronic obstructive pulmonary diseases (COPD).
  • 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 )

Sites / Locations

  • Faculty of Physical Therapy Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

pulsed electro magnetic field

Treadmilltraining

medications

Arm Description

30 patients will receive the physical therapy program in form of low frequency pulsed electro magnetic field application. with frequency 15hz, and low intensity with flux density of 20 Gauss (2mT), in pulse duration 200 usec , pulsed rectangular pulses for 60 min is applied to the dorsal surface of lower leg , ankle and foot in addition to their regular medications prescribed , 3 times per week for 8 week

In this group, 30 patient will receive the physical therapy program in form of supervised treadmill walking exercise. The exercise program consists of intermittent walking bouts to moderate claudication pain alternating with periods of rest in between for a total of 40-50 minutes . At first , a 5 minutes- warm up period will be allowed, it will include stretching exercises for calf muscles , hamstrings and quadriceps (i.e. each for at least 10 -15 seconds) . Patients should start with walking on the treadmill at a comfortable speed, and should not stop at the onset of leg pain but instead , he/she would continue until moderate pain is reached. At this point, he/she has to rest until pain completely subsides, then walking is resumed again . The intensity of exercise will be determined by claudication pain scale, and should not exceed the score of 4 on this scale. The exercise can be progressed if the patient can walk continuously for 10 minutes without the need to stop.

It includes 20 patients who will not receive any physiotherapy intervention. They will receive medical treatment only and will act as a control group.

Outcomes

Primary Outcome Measures

Ankle brachial pressure index ( ABPI )
it will be measured by doppler ultrasound
Posterior Tibial Artery Diameter ( PTA )
it will be measured by doppler ultrasound

Secondary Outcome Measures

claudication onset time (COT) or distance
it will be measured by Graded Treadmill Exercise Testing
a peak walking time (PWT) or peak walking distance.
it will be measured by Graded treadmill exercise testing

Full Information

First Posted
November 3, 2020
Last Updated
January 26, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04621097
Brief Title
Pulsed Electromagnetic Field Versus Treadmill Walking in Peripheral Arterial Disease
Official Title
Effect of Pulsed Electrmagnetic Field Versus Treadmill Training on Walking and Haemodynamic Parameters in Peripheral Arterial Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 15, 2018 (Actual)
Primary Completion Date
April 15, 2021 (Anticipated)
Study Completion Date
May 15, 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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
my study is to determine the effect of pulsed electromagnetic field versus treadmill training in managemet of intemittent claudication in peripheral arterial disease there is a lack of interventions that improves local peripheral blood circulation in ischemic lower limbs . (PEMFs) are a non-pharmacological and non-invasive treatment that can be applied on the affected body part, which penetrates through skin and reaches target tissues . However, there have been few clinical studies reporting the effects of PEMFs on hemodynamic response in people with PAD (
Detailed Description
Statement of the problem : Is there any Difference between Pulsed ElectroMagnetic Field and Supervised Treadmill walking exercise on improving exercise performance and hemodynamic parameters in patients with peripheral arterial disease The use of pulsed electromagnetic field (12hz to50hz) in improving microcirculation , microvascular blood perfusion , stimulation of nitric oxide release and stimulating angiogensis has introduced a new dimension to the physical therapy field , to the available knowledge puplished , there is no literature about analgesic and microcirculatory effect of PEMF on circulation improvement in patients with PAD , therefore the proplem of the study will be stated in a questionnary form for answering the following aspects : ( Chalidia B. etal 2011) Significance of the study : Treatment of PAD is critically important in order to minimize the risk of long term disability and improve quality of life . The need of this study developed from the lack in published studies about the effect of pulsed electromagnetic field in management of peripheral arterial diseases and also there was no available previous trials comparing the effect of PEMF and treadmill exercise on walking parameters , posterior tibial artery diameter and ABI on patients with PAD the results of this study may provide an easy non pharmacological modality for dealing with such cases . Also, the outcome of this study will guide physiotherapists to develop a new noninvasive treatment modality that may improve patient symptoms and promotes their social participation , this in turn may add to clinical role played by therapists in management of intermittent claudication in patients with peripheral arterial diseases. In Addition, increased knowledge of the influence of PEMF on microvascular function may have significant therapeutic potential and may be valuable for the intervention of diabetes-related lower limb vascular occlusion and amputation in the clinic. Does pulsed electromagnetic field will have an effect on posterior tibial artery diameter using Doppler ultrasound in patients with PAD and suffering from intermittent claudication ? Does pulsed electromagnetic field will be effective in improving the claudication pain time and distance , maximal walking free time and distance in patients with peripheral arterial disease ? Does pulsed electromagnetic field will be effective in improving the ABI ( ankle brachial pressure index in patients with peripheral arterial disease? Does non invasive pulsed electromagnetic field (PEMF) will be better than supervised treadmill walking exercise in management of intermittent claudication in patients with peripheral arterial disease ? Are there differences between PEMF and supervised treadmill walking exercise in improving exercise performance and hemodynamic parameters in patients with peripheral arterial diseases ? Purpose of the study Purposes of this study will be the following To evaluate the therapeutic efficacy of pulsed electromagnetic field On walking parameter (on Maximum walking Free time , Maximum walking Free distance, Claudication pain time , Claudication pain distance ) in management of intermittent claudication in patients with PAD . To evaluate the effect of non invasive pulsed electromagnetic field on ABI (ankle brachial pressure index) in patients with PAD suffering from intermittent claudication. To investigate the effect of non invasive PEMF on Posteriot Tibial Artery Diameter in patients with PAD suffering from intermittent claudication. To evaluate the effect of supervised treadmill walking exercise in managemet of intermittent claudication in patients with PAD to compare between the efficacy of non invasive pulsed electromagnetic field versus supervised treadmill walking exercise ( on distance and time till reaching maximum tolerated pain of intermittent claudication and also the efficacy on ankle brachial pressure index , pain intensity level ) in patients with peripheral arterial diseases suffering from intermittent claudication To gain knowledge about Non Invasive Pulsed Electromagnetic Field application and implementation in physical therapy field To share in designing an ideal protocol for the treatment of intermittent claudication in patients with PAD

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
group A : Pulsed electromagnetic field PLUS medications group B : Treadmill Training Plus Medications group C :medications only
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pulsed electro magnetic field
Arm Type
Experimental
Arm Description
30 patients will receive the physical therapy program in form of low frequency pulsed electro magnetic field application. with frequency 15hz, and low intensity with flux density of 20 Gauss (2mT), in pulse duration 200 usec , pulsed rectangular pulses for 60 min is applied to the dorsal surface of lower leg , ankle and foot in addition to their regular medications prescribed , 3 times per week for 8 week
Arm Title
Treadmilltraining
Arm Type
Experimental
Arm Description
In this group, 30 patient will receive the physical therapy program in form of supervised treadmill walking exercise. The exercise program consists of intermittent walking bouts to moderate claudication pain alternating with periods of rest in between for a total of 40-50 minutes . At first , a 5 minutes- warm up period will be allowed, it will include stretching exercises for calf muscles , hamstrings and quadriceps (i.e. each for at least 10 -15 seconds) . Patients should start with walking on the treadmill at a comfortable speed, and should not stop at the onset of leg pain but instead , he/she would continue until moderate pain is reached. At this point, he/she has to rest until pain completely subsides, then walking is resumed again . The intensity of exercise will be determined by claudication pain scale, and should not exceed the score of 4 on this scale. The exercise can be progressed if the patient can walk continuously for 10 minutes without the need to stop.
Arm Title
medications
Arm Type
Placebo Comparator
Arm Description
It includes 20 patients who will not receive any physiotherapy intervention. They will receive medical treatment only and will act as a control group.
Intervention Type
Device
Intervention Name(s)
pulsed electromagnetic field
Other Intervention Name(s)
BTL -5000 Magneto Therapy .
Intervention Description
it is a device for magnetotherapy and it is one of the most recent noninvasive physical therapy modality which is used in multiple physical therapy fields . it consist of an appliance, motorized bed and solenoid . the appliance must be connected to electrical supplying 230 =10% at a frequency of 50 or 60 HZ with earth connection . the intensity and spatial lay out of the generated magnetic field depend on the type of solenoid used
Intervention Type
Other
Intervention Name(s)
treadmill training
Other Intervention Name(s)
intermittent walking excercise
Intervention Description
supervised treadmill walking exercise. The exercise program consists of intermittent walking bouts to moderate claudication pain alternating with periods of rest in between for a total of 40-50 minutes .
Intervention Type
Drug
Intervention Name(s)
Medication
Intervention Description
regular medications
Primary Outcome Measure Information:
Title
Ankle brachial pressure index ( ABPI )
Description
it will be measured by doppler ultrasound
Time Frame
8 weeks
Title
Posterior Tibial Artery Diameter ( PTA )
Description
it will be measured by doppler ultrasound
Time Frame
8 WEEKS
Secondary Outcome Measure Information:
Title
claudication onset time (COT) or distance
Description
it will be measured by Graded Treadmill Exercise Testing
Time Frame
8 WEEKS
Title
a peak walking time (PWT) or peak walking distance.
Description
it will be measured by Graded treadmill exercise testing
Time Frame
8 WEEKS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both genders are allowed to participate in the study . The age range of patients will be from 45-65 years All patients are diagnosed with PAD since at least ( 6 months to1 year) and suffer from IC All patients will be suffering from moderate degree of pain in the calf according to claudication pain scale. ABPI for all patients will be ranged from 0.65 to 0. 9 All patients are medically and psycholigically stable . Only ambulant patient without any aids will be selected All patients are non smokers Exclusion Criteria: Patients with Severe grades of intermittent claudication that produce ischemic pain at rest Presence of claudication symptoms less than 2 months Patients with fontaine stage I PAD (asymptomatic) Patient with fontaine stage III PAD (leg pain at rest ) Patients with ABPI ( Ankle Brachial Pressure Index ≤ 0.4 ) Patients who are unable to walk on the treadmill or unable to attend sessions at the physical therapy department at APH , 3 times a week . Patients with unstable cardiovascular conditions (those with a known history of recent myocardial infarction, uncontrolled hypertension, ischemic attacks, stroke, congestive heart failure) will be excluded from this study. Patients with neurological problems that cause leg pain . Patients with active malignancy will be excluded from study Patients with acute tuberculosis, soft tissue infection, cellulities, hyperthyroidism, acute viral diseases, Patients with pace makers will be excluded from the study Patients with ischemic ulcers or gangrenes Patients with marked dyspnea on exertion or with chronic obstructive pulmonary diseases (COPD). 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 )
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
reham raafat, phd
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy Cairo University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Time Frame
within 6 months

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Pulsed Electromagnetic Field Versus Treadmill Walking in Peripheral Arterial Disease

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