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Vascular Occlusion for Optimizing Functional Improvement in Patients With Knee Osteoarthritis

NCT04996680 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-05-20

No results posted yet for this study

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.

Conditions

  • Blood Flow Restriction

Interventions

DEVICE

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

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

OTHER

Standardised low load strength training

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

DEVICE

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

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.

Sponsors & Collaborators

  • Fund for Scientific Research, Flanders, Belgium

    collaborator OTHER

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Erik Witvrouw, Prof. dr. · Rehabilitation science & Physiotherapy Ghent University

  • Jan Victor, Prof. Dr. · Orthopedics & Traumatology Ghent University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-14
Primary Completion
2024-02-27
Completion
2024-02-27
FDA Device
Yes

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04996680 on ClinicalTrials.gov