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Impact and Safety of Blood Flow Restriction in Patients With Peripheral Arterial Occlusive Disease

NCT07043114 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-06-29

No results posted yet for this study

Summary

In peripheral arterial occlusive disease (PAOD), there is a partial (stenosis) or complete occlusion of peripheral arteries, which leads to reduced arterial blood flow. The cause is atherosclerosis in about 95% of cases and in most cases the lower extremities are affected. The disease is further divided into different stages; stage II is relevant for the present study, specifically IIa. In this case, pain in the legs occurs after a few hundred meters of exertion, e.g. when walking, forcing patients to stop. This condition is also commonly known as intermittent claudication. The therapy of choice is regular gait training, a symptomatic therapy, as the initial cause, atherosclerosis, cannot be treated causally. In the present project, this gait training is supplemented by placing BFR cuffs proximally around the thighs of the patients while walking. The aim is to promote angioneogenesis, which leads to a reduction in symptoms and a corresponding increase in quality of life. A further effect of this can be greater muscle hypertrophy, which also has a positive effect.

Conditions

  • PAOD (Peripheral Arterial Obstructive Disease)

Interventions

OTHER

BFR-Walking

The training consists of the patients walking on a treadmill twice a week for a total of six weeks until their pain becomes too severe and they have to take a break. After a one-minute break, this is increased again until the pain reaches its maximum. This is done a total of three times per appointment. Additionally, patients will receive a individual BFR intervention bilaterally with a exercise pressure corresponding to 60% of their LOP.

Sponsors & Collaborators

  • University Hospital, Bonn

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2024-10-31
Completion
2024-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07043114 on ClinicalTrials.gov