دورية أكاديمية

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

التفاصيل البيبلوغرافية
العنوان: Blood flow restriction with different load levels in patients with knee osteoarthritis: protocol of a randomized controlled trial.
المؤلفون: Jardim RAC; Postgraduate Program of Health Sciences, Department of Biological Sciences and Health, Federal University of Amapá - UNIFAP, Macapá, AP, Brazil. rogerandcarv@gmail.com., de Sousa TS; Postgraduate Program of Health Sciences, Department of Biological Sciences and Health, Federal University of Amapá - UNIFAP, Macapá, AP, Brazil., Dos Santos WNN; Physical Therapy Course, Department of Biological Sciences and Health, Federal University of Amapá - UNIFAP, Macapá, AP, Brazil., Matos AP; Postgraduate Program of Health Sciences, Department of Biological Sciences and Health, Federal University of Amapá - UNIFAP, Macapá, AP, Brazil., Iosimuta NCR; Postgraduate Program of Health Sciences, Department of Biological Sciences and Health, Federal University of Amapá - UNIFAP, Macapá, AP, Brazil.
المصدر: Trials [Trials] 2022 Jan 15; Vol. 23 (1), pp. 41. Date of Electronic Publication: 2022 Jan 15.
نوع المنشور: Clinical Trial Protocol; Journal Article
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BioMed Central, 2006-
مواضيع طبية MeSH: Osteoarthritis, Knee*/diagnosis , Osteoarthritis, Knee*/therapy , Resistance Training*, Aged ; Blood Flow Restriction Therapy ; Female ; Humans ; Male ; Middle Aged ; Muscle Strength ; Quality of Life ; Randomized Controlled Trials as Topic ; Regional Blood Flow
مستخلص: 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.
(© 2022. The Author(s).)
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فهرسة مساهمة: Keywords: Blood flow restriction training; Kaatsu training; Muscle strength; Osteoarthritis of knee; Resistance training
تواريخ الأحداث: Date Created: 20220116 Date Completed: 20220118 Latest Revision: 20220120
رمز التحديث: 20221213
مُعرف محوري في PubMed: PMC8761307
DOI: 10.1186/s13063-022-05998-3
PMID: 35033169
قاعدة البيانات: MEDLINE
الوصف
تدمد:1745-6215
DOI:10.1186/s13063-022-05998-3