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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06252181
Other study ID # P.T.REC/012/004285
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 15, 2022
Est. completion date March 10, 2024

Study information

Verified date February 2024
Source Ahram Canadian University
Contact hagar El-Hadidy, lecturer
Phone 01007453552
Email hagarhadidy2016@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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)


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date March 10, 2024
Est. primary completion date March 10, 2024
Accepts healthy volunteers No
Gender Male
Age group 65 Years to 75 Years
Eligibility Inclusion Criteria: - older patients - peripheral arterial disease patients Exclusion Criteria: - cardiac elders - respiratory elders - renal elders

Study Design


Intervention

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
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)

Locations

Country Name City State
Egypt Ahram canadian university Giza

Sponsors (1)

Lead Sponsor Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary ankle brachial index it is an vascular index used in assessment of peripheral arterial disease progression It will be measured after 8 weeks
Secondary posterior tibial artery diameter increase in vascular diameter of vessel denotes improved arterial disease It will be measured after 8 weeks
Secondary claudication pain time the starting onset time of pain appearance during treadmill test It will be measured after 8 weeks
Secondary claudication pain distance the distance at which onset of pain appeared during treadmill test It will be measured after 8 weeks
Secondary Modified walking impairment questionnaire it assess degree of walking impairment in vascular disease patients It will be measured after 8 weeks
Secondary 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
Secondary 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
Secondary intermittent claudication questionnaire it will assess health-related quality of life concerning the issue of intermittent claudication it will be measured after 8 weeks
Secondary short form 36 health questionnaire it will assess general quality of life in the patients it will be measured after 8 weeks
Secondary Short physical performance battery total score or points will be assessed from this physical performance test it will be measured after 8 weeks
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