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Open Access 01-12-2022 | Knee Osteoarthritis | Study protocol

Blood flow restriction with different load levels in patients with knee osteoarthritis: protocol of a randomized controlled trial

Authors: Roger Andrey Carvalho Jardim, Tamara Silva de Sousa, Wueyla Nicoly Nascimento dos Santos, Areolino Pena Matos, Natália Camargo Rodrigues Iosimuta

Published in: Trials | Issue 1/2022

Abstract

Background

The effectiveness of blood flow restriction training (BFR) in elderly with knee osteoarthritis (OA) is comparable to performing high-intensity protocols (70 to 80% of 1 RM [repetition maximum]) that are known to be effective for improving the muscle strength of knee extensors, with the advantage of generating less particular rating of perceived exertion and pain immediately after training. However, despite being a promising alternative, little is known about the best way to apply the BFR, such as level of pressure and combination or not with other therapeutic modalities. The purpose of this study is to evaluate whether different levels of blood flow restriction with low load (BFR + LL) and no load (BFR + rest) are non-inferior to high-intensity resistance exercise (HIRE+BFRplacebo) for pain reduction in patients with knee OA.

Methods/design

This clinical trial is a non-inferiority, five-arm, randomized, active-controlled, single trial which will be carried out in 165 patients of both sexes with knee OA, aged 50 years and older. Participants will be randomly allocated into 5 exercise groups (40% of BFR + LL; 80% of BFR + LL; 40% of BFR + rest; 80% BFR + rest, and HIRE+BFR placebo). A mixed linear model will be used to examine the effect of group-by-time interaction on pain intensity on the WOMAC subscale (primary outcome) and on disease severity, physical functional data, balance data, quality of life, global perceived effect scale, and muscle strength (secondary outcomes). Participants will be analyzed for intention-to-treat, and the statistical assessor blinded to the groups. The collection of outcomes 72 h after completion of the 16 weeks of interventions will be the primary measurement point. Follow-up secondary timepoints will be collected at 20, 28, 40, 52, and 64 weeks after the end of interventions, except for pain during the training, which will be measured immediately at the end of each session. Only the comparison of the primary outcome between the HIRE group with each BFR group will be analyzed in the non-inferiority framework, the other comparisons between the BFR groups for the primary outcome, and all secondary outcomes will be interpreted in the superiority framework.

Discussion

The results of this clinical trial can point out more clearly to ways to optimize the BFR training with the minimum of pain immediately after training, which will allow the offer of an effective and more adherent strengthening training to patients with knee OA.

Trial registration

Registro Brasileiro de Ensaios Clínicos, RBR-93rx9q. Registered on 23 July 2020. Version 1.0.

Available only for authorised users

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Title: Blood flow restriction with different load levels in patients with knee osteoarthritis: protocol of a randomized controlled trial
Authors: Roger Andrey Carvalho Jardim
Tamara Silva de Sousa
Wueyla Nicoly Nascimento dos Santos
Areolino Pena Matos
Natália Camargo Rodrigues Iosimuta
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Knee Osteoarthritis
Osteoarthrosis
Osteoarthrosis
Knee Osteoarthritis
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-022-05998-3

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Blood flow restriction with different load levels in patients with knee osteoarthritis: protocol of a randomized controlled trial

Abstract

Background

Methods/design

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial registration

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