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Tai Chi for treating knee osteoarthritis: designing a long-term follow up randomized controlled trial.

ABSTRACT: Knee Osteoarthritis (KOA) is a major cause of pain and functional impairment among elders. Currently, there are neither feasible preventive intervention strategies nor effective medical remedies for the management of KOA. Tai Chi, an ancient Chinese mind-body exercise that is reported to enhance muscle function, balance and flexibility, and to reduce pain, depression and anxiety, may safely and effectively be used to treat KOA. However, current evidence is inconclusive. Our study examines the effects of a 12-week Tai Chi program compared with an attention control (wellness education and stretching) on pain, functional capacity, psychosocial variables, joint proprioception and health status in elderly people with KOA. The study will be completed by July 2009.Forty eligible patients, age > 55 yr, BMI < or = 40 kg/m2 with tibiofemoral osteoarthritis (American College of Rheumatology criteria) are identified and randomly allocated to either Tai Chi (10 modified forms from classical Yang style Tai Chi) or attention control (wellness education and stretching). The 60-minute intervention sessions take place twice weekly for 12 weeks. The study is conducted at an urban tertiary medical center in Boston, Massachusetts. The primary outcome measure is the Western Ontario and McMaster Universities (WOMAC) pain subscale at 12 weeks. Secondary outcomes include weekly WOMAC pain, function and stiffness scores, patient and physician global assessments, lower-extremity function, knee proprioception, depression, self-efficacy, social support, health-related quality of life, adherence and occurrence of adverse events after 12, 24 and 48 weeks.In this article, we present the challenges of designing a randomized controlled trial with long-term follow up. The challenges encountered in this design are: strategies for recruitment, avoidance of selection bias, the actual practice of Tai Chi, and the maximization of adherence/follow-up while conducting the clinical trial for the evaluation of the effectiveness of Tai Chi on KOA.ClinicalTrials.gov identifier: NCT00362453.

SUBMITTER: Wang C

PROVIDER: S-EPMC2529300 | biostudies-literature | 2008 Jul

REPOSITORIES: biostudies-literature

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Tai Chi for treating knee osteoarthritis: designing a long-term follow up randomized controlled trial.

Wang Chenchen C Schmid Christopher H CH Hibberd Patricia L PL Kalish Robert R Roubenoff Ronenn R Rones Ramel R Okparavero Aghogho A McAlindon Timothy T

BMC musculoskeletal disorders 20080729

<h4>Background</h4>Knee Osteoarthritis (KOA) is a major cause of pain and functional impairment among elders. Currently, there are neither feasible preventive intervention strategies nor effective medical remedies for the management of KOA. Tai Chi, an ancient Chinese mind-body exercise that is reported to enhance muscle function, balance and flexibility, and to reduce pain, depression and anxiety, may safely and effectively be used to treat KOA. However, current evidence is inconclusive. Our st ...[more]

PMID: 18664276

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Project description:BackgroundFew remedies effectively treat long-term pain and disability from knee osteoarthritis. Studies suggest that Tai Chi alleviates symptoms, but no trials have directly compared Tai Chi with standard therapies for osteoarthritis.ObjectiveTo compare Tai Chi with standard physical therapy for patients with knee osteoarthritis.DesignRandomized, 52-week, single-blind comparative effectiveness trial. (ClinicalTrials.gov: NCT01258985).SettingAn urban tertiary care academic hospital.Patients204 participants with symptomatic knee osteoarthritis (mean age, 60 years; 70% women; 53% white).InterventionTai Chi (2 times per week for 12 weeks) or standard physical therapy (2 times per week for 6 weeks, followed by 6 weeks of monitored home exercise).MeasurementsThe primary outcome was Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at 12 weeks. Secondary outcomes included physical function, depression, medication use, and quality of life.ResultsAt 12 weeks, the WOMAC score was substantially reduced in both groups (Tai Chi, 167 points [95% CI, 145 to 190 points]; physical therapy, 143 points [CI, 119 to 167 points]). The between-group difference was not significant (24 points [CI, -10 to 58 points]). Both groups also showed similar clinically significant improvement in most secondary outcomes, and the benefits were maintained up to 52 weeks. Of note, the Tai Chi group had significantly greater improvements in depression and the physical component of quality of life. The benefit of Tai Chi was consistent across instructors. No serious adverse events occurred.LimitationPatients were aware of their treatment group assignment, and the generalizability of the findings to other settings remains undetermined.ConclusionTai Chi produced beneficial effects similar to those of a standard course of physical therapy in the treatment of knee osteoarthritis.Primary funding sourceNational Center for Complementary and Integrative Health of the National Institutes of Health.

Project description:BackgroundTherapeutic exercise is a currently recommended nonpharmacological treatment for knee osteoarthritis (KOA). The optimal treatment dose (frequency or duration) has not been determined.ObjectiveTo examine dose-response relationships, minimal effective dose, and baseline factors associated with the timing of response from 2 exercise interventions in KOA.DesignSecondary analysis of a single-blind, randomized trial comparing 12-week Tai Chi and physical therapy exercise programs (Trial Registry #NCT01258985).SettingUrban tertiary care academic hospital PARTICIPANTS: A total of 182 participants with symptomatic KOA (mean age 61 years; BMI 32 kg/m2, 70% female; 55% white).MethodsWe defined dose as cumulative attendance-weeks of intervention, and treatment response as ≥20% and ≥50% improvement in pain and function. Using log-rank tests, we compared time-to-response between interventions, and used Cox regression to examine baseline factors associated with timing of response, including physical and psychosocial health, physical performance, outcome expectations, self-efficacy, and biomechanical factors.Main outcome measuresWeekly Western Ontario and McMasters Osteoarthritis Index (WOMAC) pain (0-500) and function (0-1700) scores.ResultsBoth interventions had an approximately linear dose-response effect resulting in a 9- to 11-point reduction in WOMAC pain and a 32- to 41-point improvement in function per attendance-week. There was no significant difference in overall time-to-response for pain and function between treatment groups. Median time-to-response for ≥20% improvement in pain and function was 2 attendance-weeks and for ≥50% improvement was 4-5 attendance-weeks. On multivariable models, outcome expectations were independently associated with incident function response (hazard ratio = 1.47, 95% confidence interval 1.004-2.14).ConclusionsBoth interventions have approximately linear dose-dependent effects on pain and function; their minimum effective doses range from 2-5 weeks; and patient perceived benefits of exercise influence the timing of response in KOA. These results may help clinicians to optimize patient-centered exercise treatments and better manage patient expectations.Level of evidenceII.

Project description:Objective: A pre/post pilot study was designed to investigate neurobiological mechanisms and plasma metabolites in an 8-week Tai-Chi (TC) group intervention in subjects with knee osteoarthritis. Methods: Twelve postmenopausal women underwent Tai-Chi group exercise for 8 weeks (60 min/session, three times/week). Outcomes were measured before and after Tai Chi intervention including pain intensity (VAS), Brief Pain Inventory (BPI), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), plasma metabolites (amino acids and lipids), as well as resting-state functional magnetic resonance imaging (rs-fMRI, 10 min, eyes open), diffusion tensor imaging (DTI, 12 min), and structural MRI (4.5 min) in a subgroup. Clinical data was analyzed using paired t-tests; plasma metabolites were analyzed using Wilcoxon signed-rank tests; and rs-fMRI data were analyzed using seed-based correlations of the left and right amygdala in a two-level mixed-effects model (FSL software). Correlations between amygdala-medial prefrontal cortex (mPFC) connectivity and corresponding changes in clinical outcomes were examined. DTI connectivity of each amygdala was modeled using a Bayesian approach and probabilistic tractography. The associations between neurobiological effects and pain/physical function were examined. Results: Significant pre/post changes were observed with reduced knee pain (VAS with most pain: p = 0.018; WOMAC-pain: p = 0.021; BPI with worst level: p = 0.018) and stiffness (WOMAC-stiffness, p = 0.020), that likely contributed to improved physical function (WOMAC-physical function: p = 0.018) with TC. Moderate to large effect sizes pre/post increase in rs-fMRI connectivity were observed between bilateral mPFC and the amygdala seed regions (i.e., left: d = 0.988, p = 0.355; right: d = 0.600, p = 0.282). Increased DTI connectivity was observed between bilateral mPFC and left amygdala (d = 0.720, p = 0.156). There were moderate-high correlations (r = 0.28-0.60) between TC-associated pre-post changes in amygdala-mPFC functional connectivity and pain/physical function improvement. Significantly higher levels of lysophosphatidylcholines were observed after TC but lower levels of some essential amino acids. Amino acid levels (alanine, lysine, and methionine) were lower after 8 weeks of TC and many of the lipid metabolites were higher after TC. Further, plasma non-HDL cholesterol levels were lower after TC. Conclusion: This pilot study showed moderate to large effect sizes, suggesting an important role that cortico-amygdala interactions related to TC have on pain and physical function in subjects with knee osteoarthritis pain. Metabolite analyses revealed a metabolic shift of higher lyso-lipids and lower amino acids that might suggest greater fatty acid catabolism, protein turnover and changes in lipid redistribution in response to TC exercise. The results also support therapeutic strategies aimed at strengthening functional and structural connectivity between the mPFC and the amygdala. Controlled clinical trials are warranted to confirm these observed preliminary effects.

Project description:BACKGROUND:Knee osteoarthritis (OA) causes pain and long-term disability with annual healthcare costs exceeding $185 billion in the United States. Few medical remedies effectively influence the course of the disease. Finding effective treatments to maintain function and quality of life in patients with knee OA is one of the national priorities identified by the Institute of Medicine. We are currently conducting the first comparative effectiveness and cost-effectiveness randomized trial of Tai Chi versus a physical-therapy regimen in a sample of patients with symptomatic and radiographically confirmed knee OA. This article describes the design and conduct of this trial. METHODS/DESIGN:A single-center, 52-week, comparative effectiveness randomized controlled trial of Tai Chi versus a standardized physical-therapy regimen is being conducted at an urban tertiary medical center in Boston, Massachusetts. The study population consists of adults???40 years of age with symptomatic and radiographic knee OA (American College of Rheumatology criteria). Participants are randomly allocated to either 12 weeks of Tai Chi (2x/week) or Physical Therapy (2x/week for 6 weeks, followed by 6 weeks of rigorously monitored home exercise). The primary outcome measure is pain (Western Ontario and McMaster Universities WOMAC) subscale at 12 weeks. Secondary outcomes include WOMAC stkiffness and function domain scores, lower extremity strength and power, functional balance, physical performance tests, psychological and psychosocial functioning, durability effects, health related quality of life, and healthcare utilization at 12, 24 and 52 weeks. DISCUSSION:This study will be the first randomized comparative-effectiveness and cost-effectiveness trial of Tai Chi versus Physical Therapy in a large symptomatic knee OA population with long-term follow up. We present here a robust and well-designed randomized comparative-effectiveness trial that also explores multiple outcomes to elucidate the potential mechanisms of mind-body effect for a major disabling disease with substantial health burdens and economic costs. Results of this study are expected to have important public health implications for the large and growing population with knee OA. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT01258985.

Project description:IntroductionStair ascent and descent require complex integration between sensory and motor systems; individuals with knee osteoarthritis (KOA) have an elevated risk for falls and fall injuries, which may be in part due to poor dynamic postural control during locomotion. Tai chi exercise has been shown to reduce fall risks in the ageing population and is recommended as one of the non-pharmocological therapies for people with KOA. However, neuromuscular mechanisms underlying the benefits of tai chi for persons with KOA are not clearly understood. Postural control deficits in performing a primary motor task may be more pronounced when required to simultaneously attend to a cognitive task. This single-blind, parallel design randomised controlled trial (RCT) aims to evaluate the effects of a 12-week tai chi programme versus balance and postural control training on neuromechanical characteristics during dual-task stair negotiation.Methods and analysisSixty-six participants with KOA will be randomised into either tai chi or balance and postural control training, each at 60?min per session, twice weekly for 12 weeks. Assessed at baseline and 12 weeks (ie, postintervention), the primary outcomes are attention cost and dynamic postural stability during dual-task stair negotiation. Secondary outcomes include balance and proprioception, foot clearances, self-reported symptoms and function. A telephone follow-up to assess symptoms and function will be conducted at 20 weeks. The findings will help determine whether tai chi is beneficial on dynamic stability and in reducing fall risks in older adults with KOA patients in community.Ethics and disseminationEthics approval was obtained from the Ethics Committee of the Affiliated Rehabilitation Hospital of Fujian University of Traditional Chinese Medicine (#2018KY-006-1). Study findings will be disseminated through presentations at scientific conferences or publications in peer-reviewed journals.Trial registration numberChiCTR1800018028.

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Tai Chi for treating knee osteoarthritis: designing a long-term follow up randomized controlled trial.

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Tai Chi for treating knee osteoarthritis: designing a long-term follow up randomized controlled trial.

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