Peripheral Arterial DiseaseNCT06252181
Pain and Hemodynamics in Peripheral Arterial Disease: Response to Pulsed Electromagnetic Treatment
A study testing electromagnetic pulsed therapy and elliptical exercise in people with Peripheral Arterial Disease, run by Ahram Canadian University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 65 to 75 years, men only
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- electromagnetic pulsed therapy and elliptical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2022to 10 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- older patients
- peripheral arterial disease patients
Who cannot join
- cardiac elders
- respiratory elders
- renal elders
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahram canadian university
Giza
hagar El-Hadidy, lecturer, hagarhadidy2016@gmail.com
About this study
Official title: 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
Read the 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)
- Conditions
- Peripheral Arterial Disease
- Being tested
- electromagnetic pulsed therapy, elliptical exercise
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electromagnetic pulsed therapyOther
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 exerciseOther
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)
| Study group | Role | What they receive |
|---|---|---|
| group number 1 | Experimental | 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) Receives: Other: electromagnetic pulsed therapy |
| group number 2 | Active comparator | 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) Receives: Other: elliptical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
ankle brachial index
it is an vascular index used in assessment of peripheral arterial disease progression
Measured: It will be measured after 8 weeks
Secondary outcomes (9)
posterior tibial artery diameter
increase in vascular diameter of vessel denotes improved arterial disease
Measured: It will be measured after 8 weeks
claudication pain time
the starting onset time of pain appearance during treadmill test
Measured: It will be measured after 8 weeks
claudication pain distance
the distance at which onset of pain appeared during treadmill test
Measured: It will be measured after 8 weeks
Modified walking impairment questionnaire
it assess degree of walking impairment in vascular disease patients
Measured: 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
Measured: 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
Measured: it will be measured after 8 weeks
intermittent claudication questionnaire
it will assess health-related quality of life concerning the issue of intermittent claudication
Measured: it will be measured after 8 weeks
short form 36 health questionnaire
it will assess general quality of life in the patients
Measured: it will be measured after 8 weeks
Short physical performance battery
total score or points will be assessed from this physical performance test
Measured: it will be measured after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start15 Dec 2022
- Primary completion10 Mar 2024 (estimated)
- Study completion10 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hagar Ahmed El-Hadidy, Ahram Canadian University
- Investigators
- hagar El-Hadidy, lecturer, Principal investigator, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06252181
- Sponsor's protocol ID
- P.T.REC/012/004285
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Hemodynamics in Peripheral Arterial Disease: Response to Pulsed Electromagnetic Treatment in Elderly
- ClinicalTrials.gov ID
- NCT06252181
- Acronym / sponsor ID
- P.T.REC/012/004285
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 10 Mar 2024 (estimated)
- Study completion
- 10 Mar 2024 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group number 1 | Experimental | Other: electromagnetic pulsed therapygroup 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 | Active comparator | Other: elliptical exercisepatients (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) |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- older patients
- peripheral arterial disease patients
Key exclusion criteria (3 listed)
- cardiac elders
- respiratory elders
- renal elders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electromagnetic pulsed therapypatients (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 | Other | group number 1 |
| elliptical exercisepatients (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) | Other | group number 2 |
Primary outcome
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
9 secondary outcomes
posterior tibial artery diameter
Time frame: It will be measured after 8 weeks
claudication pain time
Time frame: It will be measured after 8 weeks
claudication pain distance
Time frame: It will be measured after 8 weeks
Modified walking impairment questionnaire
Time frame: It will be measured after 8 weeks
six minute walking test (pain free distance)
Time frame: It will be measured after 8 weeks
six minute walking test (total walked distance)
Time frame: it will be measured after 8 weeks
intermittent claudication questionnaire
Time frame: it will be measured after 8 weeks
short form 36 health questionnaire
Time frame: it will be measured after 8 weeks
Short physical performance battery
Time frame: it will be measured after 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hagar El-Hadidy, lecturer principal investigator
Ahram Canadian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electromagnetic pulsed therapy and elliptical exercise in people with Peripheral Arterial Disease, run by Ahram Canadian University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact hagar El-Hadidy, lecturer (01007453552, hagarhadidy2016@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ankle brachial index (time frame: It will be measured after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.