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

NCT07043114 | Completed

• 1 other identifier: 2023_I
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

PAOD (Peripheral Arterial Obstructive Disease)

Outcome Measures

Primary Outcomes (2)

• Muscle Strength

  Isometric Maximal Strength of the Knee Extensors analyzed by Dynamometer (N)

  Pre- (Baseline) to Post-Intervention Phase (after twelve weeks of training intervention)

• Quality of Life Score

  Quality of Life assessed by Short-Form 36 Survey

  Pre- (Baseline) to Post-Intervention Phase (after twelve weeks of training intervention)

Study Arms (1)

Intervention Group

EXPERIMENTAL

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

Other: BFR-Walking

Interventions

BFR-Walking 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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PAOD Typ 2
• Eligibitly to exercise on a treadmill

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bonn: lead

Study Sites (1)

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med., B.Sc.

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: June 29, 2025
• Study Start: August 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)