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

NCT ID: NCT07043114

Last Updated: 2025-06-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-12-31

Brief 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.

Detailed Description

Any patient with stage IIa PAOD can be recruited. Patients will complete a walking training with an additionall BFR-pressure applied bilateraly and corresponding to 60% of the individual limb occlusion pressure. 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. After the first three weeks, the intensity of the training is increased by setting a higher speed on the treadmill.

Conditions

PAOD (Peripheral Arterial Obstructive Disease)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention Group

Patients with PAOD Typ II will perform a six-week walking training with BFR

Group Type: EXPERIMENTAL

BFR-Walking

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• PAOD Typ 2
• Eligibitly to exercise on a treadmill

Exclusion Criteria

• PAOD > Typ 2
• Iatrogenic changes in the vessels of the lower extremities (e.g. Stents)
• Sickle Cell Anemia
• Open Wounds/Infections on the lower extremities

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bonn

OTHER

Sponsor Role: lead

Responsible Party

Alexander Franz

Dr. med., B.Sc.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Bonn

Bonn, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

2023_I

Identifier Type: -

Identifier Source: org_study_id