CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
Blood Flow Restriction (by using smart-cuff pro devices, acting as pressurized tourniquet) combined low load strengh training +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04996680
NCT04996680N/ACompleted

Vascular Occlusion for Optimizing Functional Improvement in Patients With Knee Osteoarthritis

University Hospital, Ghent·interventional·Posted Aug 9, 2021·Updated May 20, 2024

In Brief

A clinical study evaluating Blood Flow Restriction (by using smart-cuff pro devices, acting as pressurized tourniquet) combined low load strengh training, Standardised low load strength training, and 1 other intervention for Blood Flow Restriction. Completed, enrolled 120 participants across 1 site.

Detailed Summary

Recent research in strength training physiology revealed that implementation of occlusion garments around the proximal aspect of the lower limbs in combination with low load strength training causes a reduced blood flow and thus providing a high metabolic stimulus, causing a training effect similar to high load training. This study will investigate the added effect of BFR focussing on functional outcome, pain-management and lower limb strength in patients with knee osteoarthritis. Therefore, 234 patiens will be divided into three equal groups (n=78), (control group, sham group and BFR-group) which will be subjected to a 12-week during standard strength training program, 2 times a week for 60 minutes. The first group, which will be submitted to low load resistance training commonly used in contemporary physiotherapy for OA, will serve as a control group whereas both the BFRT and Sham groups will objectify the additional value of implementing vascular occlusion in respective low load resistance training protocol.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium

Timeline

N/ACompletedFinished
20222023202420252026
First PostedAug 9, 2021
Enrollment StartJul 14, 2021
Primary CompletionFeb 27, 2024
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 4.9 years ago

Interventions

Blood Flow Restriction (by using smart-cuff pro devices, acting as pressurized tourniquet) combined low load strengh trainingdevice

This group will undergo standard, traditional low load strength training consisting of calf, thigh, glute and core exercises, combined with optimal pressurized blood flow restriction

Standardised low load strength trainingother

This group will undergo standard, traditional low load strength training consisting of calf, thigh, glute and core exercises

Sham-BFR (by using smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength trainingdevice

This group will undergo standard, traditional low load strength training consisting of calf, thigh, glute and core exercises, combined with blood flow restriction, but pressurized so the occlusion cuff has no significant effect on the lower limb blood flow.