Completed

NCT Number: NCT07043114

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

PAOD (Peripheral Arterial Obstructive Disease)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Bonn

Bonn, North Rhine-Westphalia, 53127, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Muscle Strength

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

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

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

Quality of Life assessed by Short-Form 36 Survey

Sponsors and collaborators

Lead sponsor

University Hospital, Bonn

Other

Registry information

Official study title

Influence of Walking Training in Combination With Blood Flow Restriction Training on Muscle Hypertrophy and Quality of Life in PAOD IIa

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Jun 29, 2025
Registry last updated: Jun 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting

Resoloy Initial Safety Evaluation

NCT07648017

CLTI Defined as Rutherford Category 4 or 5, PAOD (Peripheral Arterial Obstructive Disease)

Tashkent, Uzbekistan

View Trial Details