Acceptability and feasibility of a community-based strength, balance, and Tai Chi rehabilitation program in improving physical function and balance of patients after total knee arthroplasty: study protocol for a pilot randomized controlled trial

Cathy W T Lo, Matthew A Brodie, William W N Tsang, Chun-Hoi Yan, Priscillia L Lam, Chun-Ming Chan, Stephen R Lord, Arnold Y L Wong, Cathy W T Lo, Matthew A Brodie, William W N Tsang, Chun-Hoi Yan, Priscillia L Lam, Chun-Ming Chan, Stephen R Lord, Arnold Y L Wong

Abstract

Background: The rate of falls in patients after total knee arthroplasty (TKA) is high and related to lower limb muscle weakness and poor balance control. However, since routine post-TKA rehabilitation is uncommon, it is paramount to explore alternative strategies to enhance balance and physical functioning in post-TKA patients. As Tai Chi is a proven strategy for improving balance in older people, the proposed study aims to determine the feasibility and acceptability of a 12-week community-based post-TKA multimodal Tai Chi program and to collect preliminary data with respect to the efficacy of such a program in improving balance and physical functioning in post-TKA patients as compared to usual postoperative care.

Methods: A single-blinded 2-arm pilot randomized controlled trial will recruit 52 community-dwelling post-TKA patients (aged > 60 years) in Hong Kong. In addition, 26 untreated asymptomatic controls will be recruited for comparison purposes. The TKA patients will be randomized into either a 12-week multimodal Tai Chi rehabilitation group or a postoperative usual care group (26 each). Participants will perform the outcome assessments at baseline, 6, 12, 24, and 52 weeks after TKA, while asymptomatic controls will have the same assessments at baseline, 12, and 52 weeks after baseline. The rate of recruitment, retention, and attrition, as well as adherence to the intervention, will be measured and used to determine the feasibility of the study and whether a full-scale effectiveness trial is warranted. Further, qualitative interviews will be conducted to explore the acceptability and possible barriers to the implementation of the intervention. Primary and secondary outcomes including both patient-reported surveys and performance-based tests will be compared within and between groups.

Discussion: The study will determine the feasibility and acceptability/potential efficacy of community-based rehabilitation for post-TKA patients and assess whether the intervention has the potential to be assessed in a future fully powered effectiveness trial. The findings will also be used to refine the study design and guide the conduction of a future definitive randomized controlled trial.

Trial registration: ClinicalTrials.gov NCT03615638. Registered on 30 May 2018. https://ichgcp.net/clinical-trials-registry/NCT03565380.

Keywords: Balance; Coordination; Falls; Lower limb muscle strength; Multi-faceted intervention; Prevention; Rehabilitation; Tai Chi; Total knee replacement.

Conflict of interest statement

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Fig. 1
Fig. 1
A flowchart of the single-blinded 2-arm randomized controlled trial and non-randomized asymptomatic control comparative study. The multimodal program will run once per week over 12 weeks

References

    1. Levinger P, Menz H, Wee E, Feller J, Bartlett J, Bergman N. Physiological risk factors for falls in people with knee osteoarthritis before and early after knee replacement surgery. Knee Surg Sports Traumatol Arthrosc. 2011;19(7):1082–1089. doi: 10.1007/s00167-010-1325-8.
    1. George LK, Ruiz D, Jr, Sloan FA. The effects of total knee arthroplasty on physical functioning in the older population. Arthritis Rheum. 2008;58(10):3166–3171. doi: 10.1002/art.23888.
    1. Levinger P, Menz H, Morrow A, Wee E, Feller J, Bartlett J, et al. Lower limb proprioception deficits persist following knee replacement surgery despite improvements in knee extension strength. Knee Surg Sports Tr A. 2012;20(6):1097–1103. doi: 10.1007/s00167-011-1710-y.
    1. Matsumoto H, Okuno M, Nakamura T, Yamamoto K, Osaki M, Hagino H. Incidence and risk factors for falling in patients after total knee arthroplasty compared to healthy elderly individuals. Yonago Acta Medica. 2014;57(4):137–154.
    1. Matsumoto H, Okuno M, Nakamura T, Yamamoto K, Hagino H. Fall incidence and risk factors in patients after total knee arthroplasty. Arch Orthop Trauma Surg. 2012;132(4):555–563. doi: 10.1007/s00402-011-1418-y.
    1. Piva SR, Gil AB, Almeida GJM, Digioia AM, Levison TJ, Fitzgerald GK. A balance exercise program appears to improve function for patients with total knee arthroplasty: a randomized clinical trial. Phys Ther. 2010;90(6):880–894. doi: 10.2522/ptj.20090150.
    1. Pozzi F, Snyder-Mackler L, Zeni J. Physical exercise after knee arthroplasty: a systematic review of controlled trials. Eur J Phys Rehab Med. 2013;49(6):877–892.
    1. Lowe CJM, Barker KL, Dewey M, Sackley CM. Effectiveness of physiotherapy exercise after knee arthroplasty for osteoarthritis: systematic review and meta-analysis of randomised controlled trials. BMJ. 2007;335(7624):1–9. doi: 10.1136/.
    1. Frost H, Lamb SE, Robertson S. A randomized controlled trial of exercise to improve mobility and function after elective knee arthroplasty. Feasibility, results and methodological difficulties. Clin Rehabil. 2002;16(2):200–209. doi: 10.1191/0269215502cr483oa.
    1. Tsang WNW, Hui-Chan WYC. Effect of 4- and 8-wk intensive tai chi training on balance control in the elderly. Med Sci Sports Exerc. 2004;36(4):648–657. doi: 10.1249/.
    1. Chan W-N, Tsang WW-N. Effect of Tai Chi Training on dual-tasking performance that involves stepping down among stroke survivors: a pilot study. Evid Based Complement Alternat Med. 2017;2017(1):1–12. doi: 10.1155/2017/9134173.
    1. Song R, Lee EO, Lam P, Bae SC. Effects of tai chi exercise on pain, balance, muscle strength, and perceived difficulties in physical functioning in older women with osteoarthritis: a randomized clinical trial. J Rheumatol. 2003;30(9):2039–2044.
    1. Voukelatos A, Cumming RG, Lord SR, Rissel C. A randomized, controlled trial of tai chi for the prevention of falls: the Central Sydney tai chi trial. J Am Geriatr Soc. 2007;55(8):1185–1191. doi: 10.1111/j.1532-5415.2007.01244.x.
    1. Gianoudis J, Bailey CA, Ebeling PR, Nowson CA, Sanders KM, Hill K, et al. Effects of a targeted multimodal exercise program incorporating high-speed power training on falls and fracture risk factors in older adults: a community-based randomized controlled trial. J Bone Miner Res. 2014;29(1):182–191. doi: 10.1002/jbmr.2014.
    1. Piva SR, Schneider MJ, Moore CG, Catelani MB, Gil AB, Klatt BA, et al. Effectiveness of later-stage exercise programs vs usual medical care on physical function and activity after total knee replacement: a randomized clinical trial. JAMA Netw Open. 2019;2(2):e1–15. doi: 10.1001/jamanetworkopen.2019.0018.
    1. Wong AY, Lo C, Brodie M, Tsang W, Yan C, Lord S. Static and dynamic balance of patients at 1 year after total knee arthroplasty. Osteoarthr Cartil. 2019;27:S126. doi: 10.1016/j.joca.2019.02.185.
    1. Kwan MMS, Tsang WWN, Lin S-I, Greenaway M, Close JCT, Lord SR. Increased concern is protective for falls in Chinese older people: the chopstix fall risk study. J Gernontol A Biol Sci Med Sci. 2013;68(8):946–953. doi: 10.1093/gerona/gls338.
    1. Lancaster GA, Dodd S, Williamson PR. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004;10(2):307–312. doi: 10.1111/j..2002.384.doc.x.
    1. Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J Clin Epidemiol. 2012;65(3):301–308. doi: 10.1016/j.jclinepi.2011.07.011.
    1. Fitzgerald GK, Childs JD, Ridge TM, Irrgang JJ. Agility and perturbation training for a physically active individual with knee osteoarthritis. Phys Ther. 2002;82(4):372–382. doi: 10.1093/ptj/82.4.372.
    1. Borg G. Psychophysical scaling with applications in physical work and the perception of exertion. Scand J Work Environ Health. 1990;16(Suppl 1):55–58. doi: 10.5271/sjweh.1815.
    1. Hanney W. Overload principle in physical therapy. Encyclopedia of Lifestyle Medicine & Healt. 2012;1:851–852.
    1. Piva SR, Moore CG, Schneider M, Gil AB, Almeida GJ, Irrgang JJ. A randomized trial to compare exercise treatment methods for patients after total knee replacement: protocol paper. BMC Musculoskelet Disord. 2015;16:1–11. doi: 10.1186/s12891-015-0761-5.
    1. Sherrington C, Michaleff ZA, Fairhall N, Paul SS, Tiedemann A, Whitney J, et al. Exercise to prevent falls in older adults: an updated systematic review and meta-analysis. Br J Sports Med. 2017;51(24):1750–1758. doi: 10.1136/bjsports-2016-096547.
    1. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348:g1687. doi: 10.1136/bmj.g1687.
    1. Sherrington C, Whitney JC, Lord SR, Herbert RD, Cumming RG, Close JC. Effective exercise for the prevention of falls: a systematic review and meta-analysis. J Am Geriatr Soc. 2008;56(12):2234–2243. doi: 10.1111/j.1532-5415.2008.02014.x.
    1. Brodie MA, Dean RT, Beijer TR, Canning CG, Smith ST, Menant JC, et al. Symmetry matched auditory cues improve gait steadiness in most people with Parkinson’s disease but not in healthy older people. Parkinson’s Dis. 2015;5(1):105–116. doi: 10.3233/JPD-140430.
    1. Bolton JE, Wilkinson RC. Responsiveness of pain scales: a comparison of three pain intensity measures in chiropractic patients. J Manip Physiol Ther. 1998;21(1):1–7.
    1. Nilsdotter AK, Toksvig-Larsen S, Roos EM. 245 A 5 year prospective study of patient relevant outcomes after total knee replacement. Osteoarthr Cartil. 2007;15:601–606.
    1. Lautenschlager NT, Almeida OP, Flicker L, Janca A. Can physical activity improve the mental health of older adults? Ann Gen Hosp Psychiatry. 2004;3(12):1–5.
    1. Drubbel I, Numans ME, Kranenburg G, Bleijenberg N, de Wit NJ, Schuurmans MJ. Screening for frailty in primary care: a systematic review of the psychometric properties of the frailty index in community-dwelling older people. BMC Geriatr. 2014;14(27):1–13.3.
    1. Kwan MM, Tsang WW, Close JC, Lord SR. Development and validation of a chinese version of the falls efficacy scale international. Arch Gerontol Geriatr. 2013;56(1):169–174. doi: 10.1016/j.archger.2012.10.007.
    1. Padgett PK, Jacobs JV, Kasser SL. Is the BESTest at its best? A suggested brief version based on interrater reliability, validity, internal consistency, and theoretical construct. Phys Ther. 2012;92(9):1197–1207. doi: 10.2522/ptj.20120056.
    1. Brodie MA, Canning CG, Beijer TR, Lord SR. Uncontrolled head oscillations in people with Parkinson's disease may reflect an inability to respond to perturbations while walking. Physiol Meas. 2015;36(5):873–881. doi: 10.1088/0967-3334/36/5/873.
    1. Brodie MA, Menz HB, Smith ST, Delbaere K, Lord SR. Good lateral harmonic stability combined with adequate gait speed is required for low fall risk in older people. Gerontology. 2015;61(1):69–78. doi: 10.1159/000362836.
    1. Wong AY, Parent EC, Dhillon SS, Prasad N, Kawchuk GN. Do participants with low back pain who respond to spinal manipulative therapy differ biomechanically from nonresponders, untreated controls or asymptomatic controls? Spine (Phila Pa 1976) 2015;40(17):1329–1337. doi: 10.1097/BRS.0000000000000981.
    1. Wong AY, Kawchuk G, Parent E, Prasad N. Within- and between-day reliability of spinal stiffness measurements obtained using a computer controlled mechanical indenter in individuals with and without low back pain. Man Ther. 2013;18(5):395–402. doi: 10.1016/j.math.2013.02.003.
    1. Hauer K, Yardley L, Beyer N, Kempen G, Dias N, Campbell M, et al. Validation of the falls efficacy scale and falls efficacy scale international in geriatric patients with and without cognitive impairment: results of self-report and interview-based questionnaires. Gerontology. 2010;56(2):190–199. doi: 10.1159/000236027.
    1. Parkinson S, Eatough V, Holmes J, Stapley E, Midgley N. Framework analysis: a worked example of a study exploring young people’s experiences of depression. Qual Res Psychol. 2016;13(2):109–129. doi: 10.1080/14780887.2015.1119228.
    1. Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013;13:1–8. doi: 10.1186/1471-2288-13-117.
    1. Makridis K, Karachalios T. A brief history of total knee arthroplasty. In: Karachalios T, editor. Total knee arthroplasty: long term outcomes. London: Springer London; 2015. pp. 1–6.
    1. Horstmann T, Vornholt-Koch S, Brauner T, Grau S, Mündermann A. Impact of total hip arthroplasty on pain, walking ability, and cardiovascular fitness. J Orthop Res. 2012;30(12):2025–2030. doi: 10.1002/jor.22163.
    1. Swinkels A, Newman JH, Allain TJ. A prospective observational study of falling before and after knee replacement surgery. Age & Ageing. 2009;38(2):175–181. doi: 10.1093/ageing/afn229.
    1. Smith TO. Pearson M, Latham SK. Are people following hip and knee arthroplasty at greater risk of experiencing a fall and fracture? Data from the Osteoarthritis Initiative. Arch Orthop Trauma Surg. 2016;136(6):865–872. doi: 10.1007/s00402-016-2445-5.
    1. Lo CWT, Tsang WWN, Yan CH, Lord SR, Hill KD, Wong AYL. Risk factors for falls in patients with total hip arthroplasty and total knee arthroplasty: a systematic review and meta-analysis. Osteroarthr Cartilage. 2019;27(7):979–993. doi: 10.1016/j.joca.2019.04.006.
    1. Larsen K, Hansen TB, Soballe K, Kehlet H. Patient-reported outcome after fast-track knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2012;20(6):1128–1135. doi: 10.1007/s00167-012-1919-4.
    1. Winther SB, Foss OA, Wik TS, Davis SP, Engdal M, Jessen V, et al. 1-year follow-up of 920 hip and knee arthroplasty patients after implementing fast-track. Acta Orthop. 2015;86(1):78–85. doi: 10.3109/17453674.2014.957089.
    1. Dominick GM, Zeni JA, White DK. Association of psychosocial factors with physical activity and function after total knee replacement: an exploratory study. Arch Phys Med Rehabil. 2016;97(9 Suppl):S218–S225. doi: 10.1016/j.apmr.2015.09.028.
    1. Lam P. New horizons ... developing tai chi for health care. Aust Fam Physician. 1998;27(1–2):100–101.
    1. Tsai P-F, Chang JY, Beck C, Kuo Y-F, Keefe FJ. A pilot cluster-randomized trial of a 20-week tai chi program in elders with cognitive impairment and osteoarthritic knee: effects on pain and other health outcomes. J Pain Symptom Manag. 2013;45(4):60–69. doi: 10.1016/j.jpainsymman.2012.04.009.

Source: PubMed

3
Subskrybuj