Pain and Hemodynamics in Peripheral Arterial Disease: Response to Pulsed Electromagnetic Treatment

February 2, 2024 updated by: Hagar Ahmed El-Hadidy, Ahram Canadian University

Pain and Hemodynamics in Peripheral Arterial Disease: Response to Pulsed Electromagnetic Treatment in Elderly

patients with peripheral arterial disease are recommended to perform all exercise forms including elliptical type. electromagnetic treatment addition to exercise may increase benefits of this exercise

Study Overview

Detailed Description

patients (40 elderly) with peripheral arterial disease who take their medications will be divided to older patients group that receive one hour elliptical exercise (n=20 patients, exercise will be applied 3 times per the week for eight week) and a group (n=20) that receive 3 sessions per weeks of 8-week electromagnetic one-hour therapy and one hour elliptical exercise (exercise will be applied 3 times per the week for eight week)

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • 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 Backup

Study Locations

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

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • older patients
  • peripheral arterial disease patients

Exclusion Criteria:

  • cardiac elders
  • respiratory elders
  • renal elders

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
Intervention / Treatment
Experimental: group number 1
group of peripheral arterial disease elderly (n=20) that take their medications and will receive 3 sessions per weeks of 8-week electromagnetic one-hour therapy and one hour elliptical exercise (exercise will be applied 3 times per the week for eight week)
patients (20 elderly) with peripheral arterial disease who take their medications will receive one hour elliptical exercise ( exercise will be applied 3 times per the week for eight week) and 3 sessions per weeks of 8-week electromagnetic one-hour pulsed therapy
Active Comparator: group number 2
patients (20 elderly) with peripheral arterial disease who take their medications will receive one hour elliptical exercise ( exercise will be applied 3 times per the week for eight week)
patients (20 elderly) with peripheral arterial disease who take their medications will receive one hour elliptical exercise (n=20 patients, exercise will be applied 3 times per the week for eight week)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ankle brachial index
Time Frame: It will be measured after 8 weeks
it is an vascular index used in assessment of peripheral arterial disease progression
It will be measured after 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
posterior tibial artery diameter
Time Frame: It will be measured after 8 weeks
increase in vascular diameter of vessel denotes improved arterial disease
It will be measured after 8 weeks
claudication pain time
Time Frame: It will be measured after 8 weeks
the starting onset time of pain appearance during treadmill test
It will be measured after 8 weeks
claudication pain distance
Time Frame: It will be measured after 8 weeks
the distance at which onset of pain appeared during treadmill test
It will be measured after 8 weeks
Modified walking impairment questionnaire
Time Frame: It will be measured after 8 weeks
it assess degree of walking impairment in vascular disease patients
It will be measured after 8 weeks
six minute walking test (pain free distance)
Time Frame: It will be measured after 8 weeks
pain free distance walked during six minute walking test will be calculated
It will be measured after 8 weeks
six minute walking test (total walked distance)
Time Frame: it will be measured after 8 weeks
total distance walked during six minute walking test will be calculated
it will be measured after 8 weeks
intermittent claudication questionnaire
Time Frame: it will be measured after 8 weeks
it will assess health-related quality of life concerning the issue of intermittent claudication
it will be measured after 8 weeks
short form 36 health questionnaire
Time Frame: it will be measured after 8 weeks
it will assess general quality of life in the patients
it will be measured after 8 weeks
Short physical performance battery
Time Frame: it will be measured after 8 weeks
total score or points will be assessed from this physical performance test
it will be measured after 8 weeks

Collaborators and Investigators

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

Investigators

  • Principal Investigator: hagar El-Hadidy, lecturer, Ahram canadian university

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 (Actual)

December 15, 2022

Primary Completion (Estimated)

March 10, 2024

Study Completion (Estimated)

March 10, 2024

Study Registration Dates

First Submitted

February 2, 2024

First Submitted That Met QC Criteria

February 2, 2024

First Posted (Actual)

February 9, 2024

Study Record Updates

Last Update Posted (Actual)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 2, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

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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