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

January 28, 2021 updated by: ola mohamed elsayed mostafa elgohary
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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 .

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: farag abdel-moniem ali, professor
  • Phone Number: 01005446559

Study Locations

  • Egypt
      • Cairo, Egypt
        • Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

  1. Age was ranged from 45 -55years.
  2. Patients who have intermittent claudicating pain during activities not at rest.

  3. BMI between 25-29.9 kg

    -

Exclusion Criteria:

  1. patients who was not willing to participate in the study.
  2. patients who have severe foot ulcer, and who were diagnosed as Peripheral arterial insufficiency grade III, IV.
  3. patients who have the ABI is less than 0.50

  4. Patients who have past history of (unstable cardiovascular diseases, marked dyspnea on exertion or with chronic obstructive pulmonary diseases (COPD), liver and kidney diseases).

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: aerobic training program
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.
Device: Electronic Treadmill device

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
Active Comparator: myofascial release technique
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.
Other: myofascial release technique

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ankle brachial pressure index ( ABPI )
Time Frame: 8 weeks
it will measure by stethoscope and doppler
8 weeks
amount of blood flow velocity
Time Frame: 8 weeks
it will be measured by doppler ultrasound
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
claudication onset time (COT) or distance
Time Frame: 8 weeks
it will be measured by Graded Treadmill Exercise Testing
8 weeks
a peak walking time (PWT) or peak walking distance.
Time Frame: 8 weeks
it will be measured by Graded Treadmill Exercise Testing
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ola mohamed elsayed mostafa elgohary

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: nisrenn EL-NAHAS, profesor, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • aeobic training,MFR and PAD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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