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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07043114
Enrollment
10
Registered
2025-06-29
Start date
2023-08-01
Completion date
2024-12-31
Last updated
2025-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PAOD (Peripheral Arterial Obstructive Disease)

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.

Interventions

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

University Hospital, Bonn
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Muscle StrengthPre- (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 ScorePre- (Baseline) to Post-Intervention Phase (after twelve weeks of training intervention)Quality of Life assessed by Short-Form 36 Survey

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026