NCT06252181

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2024

Completed
Last Updated

February 9, 2024

Status Verified

February 1, 2024

Enrollment Period

1.2 years

First QC Date

February 2, 2024

Last Update Submit

February 2, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • ankle brachial index

    it is an vascular index used in assessment of peripheral arterial disease progression

    It will be measured after 8 weeks

Secondary Outcomes (9)

  • posterior tibial artery diameter

    It will be measured after 8 weeks

  • claudication pain time

    It will be measured after 8 weeks

  • claudication pain distance

    It will be measured after 8 weeks

  • Modified walking impairment questionnaire

    It will be measured after 8 weeks

  • six minute walking test (pain free distance)

    It will be measured after 8 weeks

  • +4 more secondary outcomes

Study Arms (2)

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)

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)

Other: elliptical exercise

Interventions

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

group number 1

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)

group number 2

Eligibility Criteria

Age65 Years - 75 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsself-representation of gender identity.
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • older patients
  • peripheral arterial disease patients

You may not qualify if:

  • cardiac elders
  • respiratory elders
  • renal elders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahram canadian university

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • hagar El-Hadidy, lecturer

    Ahram Canadian University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of physical therapy for Internal Medicine and Geriatrics

Study Record Dates

First Submitted

February 2, 2024

First Posted

February 9, 2024

Study Start

December 15, 2022

Primary Completion

March 10, 2024

Study Completion

March 10, 2024

Last Updated

February 9, 2024

Record last verified: 2024-02

Locations