Top

Trials

Published in:

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

Effect of low-load resistance training with different degrees of blood flow restriction in patients with knee osteoarthritis: study protocol for a randomized trial

Authors: Hao-Nan Wang, Yan Chen, Lin Cheng, Shen-Tao Wang, De-Xin Hu, Li-Na Wang, Guo-Xin Ni

Published in: Trials | Issue 1/2022

Abstract

Background

Knee osteoarthritis (KOA) is a common degenerative disease that causes pain, functional impairment, and reduced quality of life. Resistance training is considered as an effective approach to reduce the risk of muscle weakness in patients with KOA. Blood flow restriction (BFR) with low-load resistance training has better clinical outcomes than low-load resistance training alone. However, the degree of BFR which works more effectively with low-load resistance training has not been determined. The purpose of this study is to evaluate the effectiveness of different degrees of BFR with low-load resistance training in patients with KOA on pain, self-reported function, physical function performance, muscle strength, muscle thickness, and quality of life.

Methods

This is a study protocol for a randomized, controlled trial with blinded participants. One hundred individuals will be indiscriminately assigned into the following groups: two training groups with a BFR at 40% and 80% limb occlusion pressure (LOP), a training group without BFR, and a health education group. The three intervention groups will perform strength training for the quadriceps muscles twice a week for 12 weeks, while the health education group will attend sessions once a week for 12 weeks. The primary outcome is pain. The secondary outcomes include self-reported function, physical function performance, muscle strength of the knee extensors, muscle mass of the quadriceps, quality of life, and adverse events. Intention-to-treat analysis will be conducted for individuals who withdraw during the trial.

Discussion

Previous studies have shown that BFR with low-load resistance training is more effective than low-load resistance training alone; however, a high degree of BFR may cause discomfort during training. If a 40% LOP for BFR could produce similar clinical outcomes as an 80% LOP for BFR, resistance training with a low degree of BFR can be chosen for patients with KOA who are unbearable for a high degree of BFR.

Trial registration

Chinese Clinical Trial Registry ChiCTR2000037859 (http://www.chictr.org.cn/edit.aspx?pid=59956&htm=4). Registered on 2 September 2020

Sharma L. Osteoarthritis of the Knee. N Engl J Med. 2021;384(1):51–9. https://doi.org/10.1056/NEJMcp1903768.CrossRefPubMed

Dillon CF, Rasch EK, Gu Q, Hirsch R. Prevalence of knee osteoarthritis in the United States: arthritis data from the Third National Health and Nutrition Examination Survey 1991-94. J Rheumatol. 2006;33(11):2271–9.PubMed

Tang X, Wang S, Zhan S, Niu J, Tao K, Zhang Y, et al. The prevalence of symptomatic knee osteoarthritis in China: results from the China Health and Retirement Longitudinal Study. Arthritis & rheumatology (Hoboken, NJ). 2016;68:648–53.CrossRef

Cross M, Smith E, Hoy D, Nolte S, Ackerman I, Fransen M, et al. The global burden of hip and knee osteoarthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014;73(7):1323–30. https://doi.org/10.1136/annrheumdis-2013-204763.CrossRefPubMed

Neogi T, Zhang Y. Epidemiology of osteoarthritis. Rheum Dis Clin North Am. 2013;39(1):1–19. https://doi.org/10.1016/j.rdc.2012.10.004.CrossRefPubMed

Vina ER, Kwoh CK. Epidemiology of osteoarthritis: literature update. Curr Opin Rheumatol. 2018;30(2):160–7. https://doi.org/10.1097/BOR.0000000000000479.CrossRefPubMedPubMedCentral

Johnson VL, Hunter DJ. The epidemiology of osteoarthritis. Best Pract Res Clin Rheumatol. 2014;28(1):5–15. https://doi.org/10.1016/j.berh.2014.01.004.CrossRefPubMed

Takagi S, Omori G, Koga H, Endo K, Koga Y, Nawata A, et al. Quadriceps muscle weakness is related to increased risk of radiographic knee OA but not its progression in both women and men: the Matsudai Knee Osteoarthritis Survey. Knee Surg Sports Traumatol Arthrosc. 2018;26(9):2607–14. https://doi.org/10.1007/s00167-017-4551-5.CrossRefPubMed

Dell'isola A, Wirth W, Steultjens M, Eckstein F, Culvenor AG. Knee extensor muscle weakness and radiographic knee osteoarthritis progression. Acta Orthop. 2018;89(4):406–11. https://doi.org/10.1080/17453674.2018.1464314.CrossRefPubMedPubMedCentral

10.

Muraki S, Akune T, Teraguchi M, Kagotani R, Asai Y, Yoshida M, et al. Quadriceps muscle strength, radiographic knee osteoarthritis and knee pain: the ROAD study. BMC Musculoskelet Disord. 2015;16(1):305. https://doi.org/10.1186/s12891-015-0737-5.CrossRefPubMedPubMedCentral

11.

Lee SY, Ro HJ, Chung SG, Kang SH, Seo KM, Kim DK. Low skeletal muscle mass in the lower limbs is independently associated to knee osteoarthritis. PLoS One. 2016;11(11):e0166385. https://doi.org/10.1371/journal.pone.0166385.CrossRefPubMedPubMedCentral

12.

Cheon YH, Kim HO, Suh YS, Kim MG, Yoo WH, Kim RB, et al. Relationship between decreased lower extremity muscle mass and knee pain severity in both the general population and patients with knee osteoarthritis: Findings from the KNHANES V 1-2. PLoS One. 2017;12(3):e0173036. https://doi.org/10.1371/journal.pone.0173036.CrossRefPubMedPubMedCentral

13.

Liao CD, Chen HC, Kuo YC, Tsauo JY, Huang SW, Liou TH. Effects of muscle strength training on muscle mass gain and hypertrophy in older adults with osteoarthritis: a systematic review and meta-analysis. Arthritis Care Res. 2020;72(12):1703–18. https://doi.org/10.1002/acr.24097.CrossRef

14.

American College of Sports Medicine position stand. Progression models in resistance training for healthy adults. Med Sci Sports Exerc. 2009;41(3):687–708. https://doi.org/10.1249/MSS.0b013e3181915670.CrossRef

15.

Jan MH, Lin JJ, Liau JJ, Lin YF, Lin DH. Investigation of clinical effects of high- and low-resistance training for patients with knee osteoarthritis: a randomized controlled trial. Phys Ther. 2008;88(4):427–36. https://doi.org/10.2522/ptj.20060300.CrossRefPubMed

16.

Takarada Y, Nakamura Y, Aruga S, Onda T, Miyazaki S, Ishii N. Rapid increase in plasma growth hormone after low-intensity resistance exercise with vascular occlusion. J Appl Physiol (1985). 2000;88:61–5.CrossRef

17.

Reeves GV, Kraemer RR, Hollander DB, Clavier J, Thomas C, Francois M, et al. Comparison of hormone responses following light resistance exercise with partial vascular occlusion and moderately difficult resistance exercise without occlusion. J Appl Physiol (1985). 2006;101:1616–22.CrossRef

18.

Moore DR, Burgomaster KA, Schofield LM, Gibala MJ, Sale DG, Phillips SM. Neuromuscular adaptations in human muscle following low intensity resistance training with vascular occlusion. Eur J Appl Physiol. 2004;92(4-5):399–406. https://doi.org/10.1007/s00421-004-1072-y.CrossRefPubMed

19.

Segal N, Davis MD, Mikesky AE. Efficacy of blood flow-restricted low-load resistance training for quadriceps strengthening in men at risk of symptomatic knee osteoarthritis. Geriatr Orthop Surg Rehabil. 2015;6(3):160–7. https://doi.org/10.1177/2151458515583088.CrossRefPubMedPubMedCentral

20.

Segal NA, Williams GN, Davis MC, Wallace RB, Mikesky AE. Efficacy of blood flow-restricted, low-load resistance training in women with risk factors for symptomatic knee osteoarthritis. PM R. 2015;7(4):376–84. https://doi.org/10.1016/j.pmrj.2014.09.014.CrossRefPubMed

21.

Bryk FF, Dos Reis AC, Fingerhut D, Araujo T, Schutzer M, Cury Rde P, et al. Exercises with partial vascular occlusion in patients with knee osteoarthritis: a randomized clinical trial. Knee Surg Sports Traumatol Arthrosc. 2016;24(5):1580–6. https://doi.org/10.1007/s00167-016-4064-7.CrossRefPubMed

22.

Ferraz RB, Gualano B, Rodrigues R, Kurimori CO, Fuller R, Lima FR, et al. Benefits of resistance training with blood flow restriction in knee osteoarthritis. Med Sci Sports Exerc. 2018;50(5):897–905. https://doi.org/10.1249/MSS.0000000000001530.CrossRefPubMed

23.

Jessee MB, Buckner SL, Dankel SJ, Counts BR, Abe T, Loenneke JP. The influence of cuff width, sex, and race on arterial occlusion: implications for blood flow restriction research. Sports Med. 2016;46(6):913–21. https://doi.org/10.1007/s40279-016-0473-5.CrossRefPubMed

24.

Loenneke JP, Fahs CA, Rossow LM, Sherk VD, Thiebaud RS, Abe T, et al. Effects of cuff width on arterial occlusion: implications for blood flow restricted exercise. Eur J Appl Physiol. 2012;112(8):2903–12. https://doi.org/10.1007/s00421-011-2266-8.CrossRefPubMed

25.

Soligon SD, Lixandrão ME, Biazon T, Angleri V, Roschel H, Libardi CA. Lower occlusion pressure during resistance exercise with blood-flow restriction promotes lower pain and perception of exercise compared to higher occlusion pressure when the total training volume is equalized. Physiol Int. 2018;105(3):276–84. https://doi.org/10.1556/2060.105.2018.3.18.CrossRefPubMed

26.

Wang HN, Chen Y, Cheng L, Cai YH, Li W, Ni GX. Efficacy and safety of blood flow restriction training in patients with knee osteoarthritis: a systematic review and meta-analysis. Arthritis Care Res. 2021. https://doi.org/10.1002/acr.24787.

27.

Gay C, Chabaud A, Guilley E, Coudeyre E. Educating patients about the benefits of physical activity and exercise for their hip and knee osteoarthritis. Systematic literature review. Ann Phys Rehabil Med. 2016;59(3):174–83. https://doi.org/10.1016/j.rehab.2016.02.005.CrossRefPubMed

28.

Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7. https://doi.org/10.7326/0003-4819-158-3-201302050-00583.CrossRefPubMedPubMedCentral

29.

Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ (Clinical research ed). 2008;337:a2390.CrossRef

30.

Fernandes L, Hagen KB, Bijlsma JW, Andreassen O, Christensen P, Conaghan PG, et al. EULAR recommendations for the non-pharmacological core management of hip and knee osteoarthritis. Ann Rheum Dis. 2013;72(7):1125–35. https://doi.org/10.1136/annrheumdis-2012-202745.CrossRefPubMed

31.

Kellgren JH, Lawrence JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957;16(4):494–502. https://doi.org/10.1136/ard.16.4.494.CrossRefPubMedPubMedCentral

32.

Giles L, Webster KE, McClelland J, Cook JL. Quadriceps strengthening with and without blood flow restriction in the treatment of patellofemoral pain: a double-blind randomised trial. Br J Sports Med. 2017;51(23):1688–94. https://doi.org/10.1136/bjsports-2016-096329.CrossRefPubMed

33.

Powers CM, Ho KY, Chen YJ, Souza RB, Farrokhi S. Patellofemoral joint stress during weight-bearing and non-weight-bearing quadriceps exercises. J Orthop Sports Phys Ther. 2014;44(5):320–7. https://doi.org/10.2519/jospt.2014.4936.CrossRefPubMed

34.

Astephen JL, Deluzio KJ, Caldwell GE, Dunbar MJ. Biomechanical changes at the hip, knee, and ankle joints during gait are associated with knee osteoarthritis severity. J Orthop Res. 2008;26(3):332–41. https://doi.org/10.1002/jor.20496.CrossRefPubMed

35.

Hislop AC, Collins NJ, Tucker K, Deasy M, Semciw AI. Does adding hip exercises to quadriceps exercises result in superior outcomes in pain, function and quality of life for people with knee osteoarthritis? A systematic review and meta-analysis. Br J Sports Med. 2020;54(5):263–71. https://doi.org/10.1136/bjsports-2018-099683.CrossRefPubMed

36.

Thomas SG, Pagura SM, Kennedy D. Physical activity and its relationship to physical performance in patients with end stage knee osteoarthritis. J Orthop Sports Phys Ther. 2003;33(12):745–54. https://doi.org/10.2519/jospt.2003.33.12.745.CrossRefPubMed

37.

Reynolds JM, Gordon TJ, Robergs RA. Prediction of one repetition maximum strength from multiple repetition maximum testing and anthropometry. J Strength Cond Res. 2006;20(3):584–92.PubMed

38.

Abadie BR, Wentworth MC. Prediction of one repetition maximal strength from a 5-10 repetition submaximal strength test in college-aged females. J. Exerc. Physiol. Online. 2000;3(3):1–8.

39.

McNair PJ, Colvin M, Reid D. Predicting maximal strength of quadriceps from submaximal performance in individuals with knee joint osteoarthritis. Arthritis Care Res. 2011;63(2):216–22. https://doi.org/10.1002/acr.20368.CrossRef

40.

Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990;13(4):227–36. https://doi.org/10.1002/nur.4770130405.CrossRefPubMed

41.

Tubach F, Ravaud P, Baron G, Falissard B, Logeart I, Bellamy N, et al. Evaluation of clinically relevant changes in patient reported outcomes in knee and hip osteoarthritis: the minimal clinically important improvement. Ann Rheum Dis. 2005;64(1):29–33. https://doi.org/10.1136/ard.2004.022905.CrossRefPubMed

42.

Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988;15(12):1833–40.PubMed

43.

Symonds T, Hughes B, Liao S, Ang Q, Bellamy N. Validation of the Chinese Western Ontario and McMaster Universities Osteoarthritis Index in patients from Mainland China with osteoarthritis of the knee. Arthritis Care Res. 2015;67(11):1553–60. https://doi.org/10.1002/acr.22631.CrossRef

44.

Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991;39(2):142–8. https://doi.org/10.1111/j.1532-5415.1991.tb01616.x.CrossRefPubMed

45.

Alghadir A, Anwer S, Brismée JM. The reliability and minimal detectable change of Timed Up and Go test in individuals with grade 1-3 knee osteoarthritis. BMC Musculoskelet Disord. 2015;16(1):174. https://doi.org/10.1186/s12891-015-0637-8.CrossRefPubMedPubMedCentral

46.

Harper SA, Roberts LM, Layne AS, Jaeger BC, Gardner AK, Sibille KT, et al. Blood-flow restriction resistance exercise for older adults with knee osteoarthritis: a pilot randomized clinical trial. J Clin Med. 2019;8(2). https://doi.org/10.3390/jcm8020265.

47.

Hall M, Hinman RS, Wrigley TV, Kasza J, Lim BW, Bennell KL. Knee extensor strength gains mediate symptom improvement in knee osteoarthritis: secondary analysis of a randomised controlled trial. Osteoarthr Cartil. 2018;26(4):495–500. https://doi.org/10.1016/j.joca.2018.01.018.CrossRef

48.

Wessel J. Isometric strength measurements of knee extensors in women with osteoarthritis of the knee. J Rheumatol. 1996;23(2):328–31.PubMed

49.

Kim D, Loenneke JP, Thiebaud RS, Abe T, Bemben MG. The acute muscular effects of cycling with and without different degrees of blood flow restriction. Acta Physiol Hung. 2015;102(4):428–41. https://doi.org/10.1556/036.102.2015.4.10.CrossRefPubMed

50.

Giles LS, Webster KE, McClelland JA, Cook J. Can ultrasound measurements of muscle thickness be used to measure the size of individual quadriceps muscles in people with patellofemoral pain? Phys Ther Sport. 2015;16(1):45–52. https://doi.org/10.1016/j.ptsp.2014.04.002.CrossRefPubMed

51.

Giles LS, Webster KE, McClelland JA, Cook J. Atrophy of the quadriceps is not isolated to the vastus medialis oblique in individuals with patellofemoral pain. J Orthop Sports Phys Ther. 2015;45(8):613–9. https://doi.org/10.2519/jospt.2015.5852.CrossRefPubMed

52.

Fransen M, McConnell S, Harmer AR, Van der Esch M, Simic M, Bennell KL. Exercise for osteoarthritis of the knee: a Cochrane systematic review. Br J Sports Med. 2015;49(24):1554–7. https://doi.org/10.1136/bjsports-2015-095424.CrossRefPubMed

53.

Jansen MJ, Viechtbauer W, Lenssen AF, Hendriks EJ, de Bie RA. Strength training alone, exercise therapy alone, and exercise therapy with passive manual mobilisation each reduce pain and disability in people with knee osteoarthritis: a systematic review. J Physiother. 2011;57(1):11–20. https://doi.org/10.1016/S1836-9553(11)70002-9.CrossRefPubMed

54.

White IR, Royston P, Wood AM. Multiple imputation using chained equations: Issues and guidance for practice. Stat Med. 2011;30(4):377–99. https://doi.org/10.1002/sim.4067.CrossRefPubMed

Title: Effect of low-load resistance training with different degrees of blood flow restriction in patients with knee osteoarthritis: study protocol for a randomized trial
Authors: Hao-Nan Wang
Yan Chen
Lin Cheng
Shen-Tao Wang
De-Xin Hu
Li-Na Wang
Guo-Xin Ni
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Knee Osteoarthritis
Knee Osteoarthritis
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-021-05946-7

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Effect of low-load resistance training with different degrees of blood flow restriction in patients with knee osteoarthritis: study protocol for a randomized trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

Please log in to get access to this content

Other articles of this Issue 1/2022

The Positive Choices trial: update to study protocol for a phase-III RCT trial of a whole-school social-marketing intervention to promote sexual health and reduce health inequalities

Health Information and Monitoring of Sexually Transmitted Infections (SIM study): a single-center, parallel, three-arm randomized controlled trial protocol for enhancing adherence to syphilis treatment and follow-up

Caries inhibition with CO2-laser during orthodontic treatment: a study protocol for a randomized split-mouth controlled clinical trial

Self-guided virtual reality therapy for social anxiety disorder: a study protocol for a randomized controlled trial

Cerebral mechanism of opposing needling for managing acute pain after unilateral total knee arthroplasty: study protocol for a randomized, sham-controlled clinical trial

Design of a multinational randomized controlled trial to assess the effects of structured and individualized exercise in patients with metastatic breast cancer on fatigue and quality of life: the EFFECT study