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EFFECT OF AEROBIC TRAINING VERSUS MYOFACIAL RELEASE ON CLAUDICATION AMONG PREPHERAIL ARTERAIL INSUFFIECENCY PATIENTS

Primary Purpose

Peripheral Arterial Disease

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Electronic Treadmill device

myofascial release technique

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

45 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:The patients had been met the following criteria to be involved in this study:

1. Patients from both sexes who were medically diagnosed as peripheral arterial insufficiency with type II claudication at single lower limb 2- Peripheral arterial insufficiency patients, who have ABI inbetween0.90-0.50

Age was ranged from 45 -55years.
Patients who have intermittent claudicating pain during activities not at rest.
BMI between 25-29.9 kg
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Exclusion Criteria:

patients who was not willing to participate in the study.
patients who have severe foot ulcer, and who were diagnosed as Peripheral arterial insufficiency grade III, IV.
patients who have the ABI is less than 0.50
Patients who have past history of (unstable cardiovascular diseases, marked dyspnea on exertion or with chronic obstructive pulmonary diseases (COPD), liver and kidney diseases).
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Sites / Locations

Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

aerobic training program

myofascial release technique

Arm Description

group a:twenty patients who will receive aerobic training program combine with traditional burger exercises for 45 mints, 3 times per week for two months as a total treatment period in addition to their medical treatment.

group B: twenty patients who will receive myofascial release technique combine with traditional burger exercises for 45 mints, 3 times per week for two months as a total treatment period in addition to their medical treatment.

Outcomes

Primary Outcome Measures

Ankle brachial pressure index ( ABPI )

it will measure by stethoscope and doppler

amount of blood flow velocity

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

NCT ID

NCT04734600

First Posted

January 28, 2021

Last Updated

January 28, 2021

Sponsor

ola mohamed elsayed mostafa elgohary

Collaborators

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT04734600

Brief Title

EFFECT OF AEROBIC TRAINING VERSUS MYOFACIAL RELEASE ON CLAUDICATION AMONG PREPHERAIL ARTERAIL INSUFFIECENCY PATIENTS

Official Title

EFFECT OF AEROBIC TRAINING VERSUS MYOFACIAL RELEASE ON CLAUDICATION AMONG PREPHERAIL ARTERAIL INSUFFIECENCY PATIENTS

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2021 (Anticipated)

Primary Completion Date

April 15, 2021 (Anticipated)

Study Completion Date

May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

ola mohamed elsayed mostafa elgohary

Collaborators

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This study is trying to answer the following research question: "Are there any differences between effects of aerobic training and myofascial release on claudication among peripheral arterial insuffiency patients?

Detailed Description

Peripheral arterial disease is a systemic disorder and for the most part progressive. The condition is associated with life and limb-threatening complications. Symptoms of PAD range from intermittent claudication-defined as fatigue or discomfort in calf, buttock, or thigh muscles on exertion that is relieved by rest-to critical limb ischemia-defined as distal leg pain at rest with or without ischemic ulcers Despite many advances in endovascular surgery, amputations of digits and limbs are not uncommon. Thus, the present-day approach is to prevent the disorder in the first place. There are many evidences that support changes in lifestyle can significantly decrease the rate of progression of the disease and improve the quality of life in addition to aerobic training exercise and manual therapy .

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

40 patient having single leg intermittent claudication pain

Masking

Participant

Masking Description

AEROBIC TRAINING VERSUS MYOFACIAL RELEASE ON CLAUDICATION AMONG PREPHERAIL ARTERAIL INSUFFIECENCY PATIENTS

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

aerobic training program

Arm Type

Experimental

Arm Description

Arm Title

myofascial release technique

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Electronic Treadmill device

Intervention Description

group A:PN-7001M Panasonic Treadmill 130 kg, frequency 50 HZ, input voltage AC220 V, input power 100W+_ 10 will usefor aerobic training program ,start by 1pbm grading to 2pbm speed and increase according to patient abilities during sessions ,0% treadmill inclination angle for two month as a total treatment period for study group patients. Patients in this group will participate in aerobic training as march walking on treadmill for 45 mints duration for session 3 times per week, start with 5 mints warm up beginning and 5 mints cooling down at end session, in addition to their medical program and burger exercises

Intervention Type

Other

Intervention Name(s)

myofascial release technique

Intervention Description

group B:The myofascial release technique group will receive a 45 mints session time, for3 times per week for two months in addition to their medical program and burger exercises. Before the MF will starte, patient will rested in a relaxed prone position for 15 to 30 mints and also after end session time, MF protocol will applied as follow sequence over all period of total treatment sessions (8) week.: thoracolumbar cross hand facial release technique for at least 5 mints for every barrier depth area, started by one hand will place on high thoracic area with pressure applied cephalic, the other hand was placed directly on the lower lumbo -sacrum area pushing caudal and arms are crossed to maximize as leverage as the barrier sense of softening will occurre and release sense on fascia under hand (release done at transverse alternative with longitudinal direction)alternation same methods to affected leg

Primary Outcome Measure Information:

Title

Ankle brachial pressure index ( ABPI )

Description

it will measure by stethoscope and doppler

Time Frame

8 weeks

Title

amount of blood flow velocity

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

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria:The patients had been met the following criteria to be involved in this study: 1. Patients from both sexes who were medically diagnosed as peripheral arterial insufficiency with type II claudication at single lower limb 2- Peripheral arterial insufficiency patients, who have ABI inbetween0.90-0.50 Age was ranged from 45 -55years. Patients who have intermittent claudicating pain during activities not at rest. BMI between 25-29.9 kg - Exclusion Criteria: patients who was not willing to participate in the study. patients who have severe foot ulcer, and who were diagnosed as Peripheral arterial insufficiency grade III, IV. patients who have the ABI is less than 0.50 Patients who have past history of (unstable cardiovascular diseases, marked dyspnea on exertion or with chronic obstructive pulmonary diseases (COPD), liver and kidney diseases). -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

ola elgohary

Phone

01227191398

ola_elgoharyy@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

farag abdel-moniem ali, professor

Phone

01005446559

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

nisrenn EL-NAHAS, profesor

Organizational Affiliation

Cairo University

Official's Role

Study Director

Facility Information:

Facility Name

Physical Therapy

City

Cairo

Country

Egypt

Facility Contact:

First Name & Middle Initial & Last Name & Degree

FARAG ABD-ELMONEIM ALY, professor

Phone

01005446559

First Name & Middle Initial & Last Name & Degree

niseen GHAREB EL-NAHAS, pofessor

Phone

0100227242

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27754945

Citation

McDermott MM, Polonsky TS. Home-Based Exercise: A Therapeutic Option for Peripheral Artery Disease. Circulation. 2016 Oct 18;134(16):1127-1129. doi: 10.1161/CIRCULATIONAHA.116.023691. No abstract available.

Results Reference

background

PubMed Identifier

24177266

Citation

Prevost A, Lafitte M, Pucheu Y, Couffinhal T; on behalf the CEPTA educational team. Education and home based training for intermittent claudication: functional effects and quality of life. Eur J Prev Cardiol. 2015 Mar;22(3):373-9. doi: 10.1177/2047487313512217. Epub 2013 Oct 31.

Results Reference

background

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EFFECT OF AEROBIC TRAINING VERSUS MYOFACIAL RELEASE ON CLAUDICATION AMONG PREPHERAIL ARTERAIL INSUFFIECENCY PATIENTS

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