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

University Hospital Bonn (UKB)

Status: Completed

Conditions: PAOD (Peripheral Arterial Obstructive Disease)

Treatments: Other: BFR-Walking

Study type: Interventional

Funder types: Other

Identifiers

NCT07043114

2023_I

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Intervention Group

Experimental group

Description:

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

Treatment:

Other: BFR-Walking