Pulsed Electromagnetic Field Versus Treadmill Walking in Peripheral Arterial Disease

NCT04621097 | Unknown DMC

• 1 other identifier: P.T.REC/012/002122
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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 (

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• Ankle brachial pressure index ( ABPI )

  it will be measured by doppler ultrasound

  8 weeks

• Posterior Tibial Artery Diameter ( PTA )

  it will be measured by doppler ultrasound

  8 WEEKS

Secondary Outcomes (2)

• claudication onset time (COT) or distance

  8 WEEKS

• a peak walking time (PWT) or peak walking distance.

  8 WEEKS

Study Arms (3)

pulsed electro magnetic field

EXPERIMENTAL

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

Device: pulsed electromagnetic field

Treadmilltraining

EXPERIMENTAL

* 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.

Other: treadmill training

medications

PLACEBO COMPARATOR

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

Drug: Medication

Interventions

pulsed electromagnetic field DEVICE

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

Also known as: BTL -5000 Magneto Therapy .

pulsed electro magnetic field

treadmill training OTHER

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 .

Also known as: intermittent walking excercise

Treadmilltraining

Medication DRUG

regular medications

medications

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Dosage Forms

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques

Study Officials

• reham raafat, phd

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: REHAM RAAFAT

Model Details: group A : Pulsed electromagnetic field PLUS medications group B : Treadmill Training Plus Medications group C :medications only

Study Record Dates

• First Submitted: November 3, 2020
• First Posted: November 9, 2020
• Study Start: December 15, 2018
• Primary Completion: April 15, 2021
• Study Completion: May 15, 2021
• Last Updated: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: within 6 months

Locations

EG (1)