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

Not Applicable

Recruiting

• Conditions: Peripheral Arterial Disease
• Interventions: Other: electromagnetic pulsed therapy; Other: elliptical exercise

• Registration Number: NCT06252181
• Lead Sponsor: Ahram Canadian University

Brief Summary

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

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 Timeline

• Study Start: 2022-12-15
• Status Verified: 2024-02
• Study First Submitted: 2024-02-02
• Study First Submitted QC: 2024-02-02
• Last Update Submitted: 2024-02-02
• Study First Posted: 2024-02-09
• Last Update Posted: 2024-02-09
• Primary Completion: 2024-03-10
• Study Completion: 2024-03-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• older patients
• peripheral arterial disease patients

Exclusion Criteria

• cardiac elders
• respiratory elders
• renal elders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group number 1	electromagnetic pulsed therapy	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)
group number 2	elliptical exercise	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)

Primary Outcome Measures

Name	Time	Method
ankle brachial index	It will be measured after 8 weeks	it is an vascular index used in assessment of peripheral arterial disease progression

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ahram canadian university; 🇪🇬 Giza, Egypt