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

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

• Status: Recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Other: electromagnetic pulsed therapy; Other: elliptical exercise

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

• Study Contact: Name: hagar El-Hadidy, lecturer; Phone Number: 01007453552; Email: hagarhadidy2016@gmail.com
• Study Contact Backup: Name: omnia ahmed; Phone Number: 01227805225; Email: omniasaeedmahmoud2021@gmail.com

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Ahram Canadian University
    • Contact: hagar El-Hadidy, lecturer; Email: hagarhadidy2016@gmail.com

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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)	Other: electromagnetic pulsed therapy; 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)	Other: elliptical exercise; 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	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	increase in vascular diameter of vessel denotes improved arterial disease	It will be measured after 8 weeks
claudication pain time	the starting onset time of pain appearance during treadmill test	It will be measured after 8 weeks
claudication pain distance	the distance at which onset of pain appeared during treadmill test	It will be measured after 8 weeks
Modified walking impairment questionnaire	it assess degree of walking impairment in vascular disease patients	It will be measured after 8 weeks
six minute walking test (pain free distance)	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)	total distance walked during six minute walking test will be calculated	it will be measured after 8 weeks
intermittent claudication questionnaire	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	it will assess general quality of life in the patients	it will be measured after 8 weeks
Short physical performance battery	total score or points will be assessed from this physical performance test	it will be measured after 8 weeks

Collaborators and Investigators

• Sponsor: Ahram Canadian University
• Investigators: Principal Investigator: hagar El-Hadidy, lecturer, Ahram Canadian University

Study record dates

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

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: P.T.REC/012/004285

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No