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A novel comparative effectiveness study of Tai Chi versus aerobic exercise for fibromyalgia: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:Fibromyalgia is a chronic musculoskeletal pain syndrome that causes substantial physical and psychological impairment and costs the US healthcare system over $25 billion annually. Current pharmacological therapies may cause serious adverse effects, are expensive, and fail to effectively improve pain and function. Finding new and effective non-pharmacological treatments for fibromyalgia patients is urgently needed. We are currently conducting the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise (a recommended component of the current standard of care) in a large fibromyalgia population. This article describes the design and conduct of this trial. METHODS/DESIGN:A single-center, 52-week, randomized controlled trial of Tai Chi versus aerobic exercise is being conducted at an urban tertiary medical center in Boston, Massachusetts. We plan to recruit 216 patients with fibromyalgia. The study population consists of adults ?21 years of age with fibromyalgia who meet American College of Rheumatology 1990 and 2010 diagnostic criteria. Participants are randomized to one of four Tai Chi intervention groups: 12 or 24 weeks of supervised Tai Chi held once or twice per week, or a supervised aerobic exercise control held twice per week for 24 weeks. The primary outcome is the change in Revised Fibromyalgia Impact Questionnaire total score from baseline to 24 weeks. Secondary outcomes include measures of widespread pain, symptom severity, functional performance, balance, muscle strength and power, psychological functioning, sleep quality, self-efficacy, durability effects, and health-related quality of life at 12, 24, and 52 week follow-up. DISCUSSION:This study is the first comparative effectiveness randomized trial of Tai Chi versus aerobic exercise in a large fibromyalgia population with long-term follow up. We present here a robust and well-designed trial to determine the optimal frequency and duration of a supervised Tai Chi intervention with regard to short- and long-term effectiveness. The trial also explores multiple outcomes to elucidate the potential mechanisms of Tai Chi and aerobic exercise and the generalizability of these interventions across instructors. Results of this study are expected to have important public health implications for patients with a major disabling disease that incurs substantial health burdens and economic costs. TRIAL REGISTRATION:ClinicalTrials.gov identifier: NCT01420640 , registered 18 August 2011.

SUBMITTER: Wang C

PROVIDER: S-EPMC4323027 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature

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A novel comparative effectiveness study of Tai Chi versus aerobic exercise for fibromyalgia: study protocol for a randomized controlled trial.

Wang Chenchen C McAlindon Timothy T Fielding Roger A RA Harvey William F WF Driban Jeffrey B JB Price Lori Lyn LL Kalish Robert R Schmid Anna A Scott Tammy M TM Schmid Christopher H CH

Trials 20150130

<h4>Background</h4>Fibromyalgia is a chronic musculoskeletal pain syndrome that causes substantial physical and psychological impairment and costs the US healthcare system over $25 billion annually. Current pharmacological therapies may cause serious adverse effects, are expensive, and fail to effectively improve pain and function. Finding new and effective non-pharmacological treatments for fibromyalgia patients is urgently needed. We are currently conducting the first comparative effectiveness ...[more]

PMID: 25633475

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Project description:OBJECTIVES:To determine the effectiveness of tai chi interventions compared with aerobic exercise, a current core standard treatment in patients with fibromyalgia, and to test whether the effectiveness of tai chi depends on its dosage or duration. DESIGN:Prospective, randomized, 52 week, single blind comparative effectiveness trial. SETTING:Urban tertiary care academic hospital in the United States between March 2012 and September 2016. PARTICIPANTS:226 adults with fibromyalgia (as defined by the American College of Rheumatology 1990 and 2010 criteria) were included in the intention to treat analyses: 151 were assigned to one of four tai chi groups and 75 to an aerobic exercise group. INTERVENTIONS:Participants were randomly assigned to either supervised aerobic exercise (24 weeks, twice weekly) or one of four classic Yang style supervised tai chi interventions (12 or 24 weeks, once or twice weekly). Participants were followed for 52 weeks. Adherence was rigorously encouraged in person and by telephone. MAIN OUTCOME MEASURES:The primary outcome was change in the revised fibromyalgia impact questionnaire (FIQR) scores at 24 weeks compared with baseline. Secondary outcomes included changes of scores in patient's global assessment, anxiety, depression, self efficacy, coping strategies, physical functional performance, functional limitation, sleep, and health related quality of life. RESULTS:FIQR scores improved in all five treatment groups, but the combined tai chi groups improved statistically significantly more than the aerobic exercise group in FIQR scores at 24 weeks (difference between groups=5.5 points, 95% confidence interval 0.6 to 10.4, P=0.03) and several secondary outcomes (patient's global assessment=0.9 points, 0.3 to 1.4, P=0.005; anxiety=1.2 points, 0.3 to 2.1, P=0.006; self efficacy=1.0 points, 0.5 to 1.6, P=0.0004; and coping strategies, 2.6 points, 0.8 to 4.3, P=0.005). Tai chi treatment compared with aerobic exercise administered with the same intensity and duration (24 weeks, twice weekly) had greater benefit (between group difference in FIQR scores=16.2 points, 8.7 to 23.6, P<0.001). The groups who received tai chi for 24 weeks showed greater improvements than those who received it for 12 weeks (difference in FIQR scores=9.6 points, 2.6 to 16.6, P=0.007). There was no significant increase in benefit for groups who received tai chi twice weekly compared with once weekly. Participants attended the tai chi training sessions more often than participants attended aerobic exercise. The effects of tai chi were consistent across all instructors. No serious adverse events related to the interventions were reported. CONCLUSION:Tai chi mind-body treatment results in similar or greater improvement in symptoms than aerobic exercise, the current most commonly prescribed non-drug treatment, for a variety of outcomes for patients with fibromyalgia. Longer duration of tai chi showed greater improvement. This mind-body approach may be considered a therapeutic option in the multidisciplinary management of fibromyalgia. TRIAL REGISTRATION:ClinicalTrials.gov NCT01420640.

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:BackgroundCompared with optimal blood pressure (BP), the prehypertension increases the risk of incident hypertension, cardiovascular (CV) events, and death. Moderate intensity of regular physical activity can reduce BP. However, aerobic exercise has some limitations. As a safe, low-impact, enjoyable, and inexpensive form of exercise that requires minimal equipment and space, Tai Chi is expected as a viable alternative to aerobic exercise. The study aimed to assess the effect of Tai Chi intervention program, compared with aerobic exercise, on the BP in prehypertension patients.MethodsThis study is a 12-month, two-center, single-blind, parallel, randomized controlled trial. Three hundred forty-two patients with prehypertension [with a systolic blood pressure (SBP) in the range of 120 mmHg to 139 mmHg and/or a diastolic blood pressure (DBP) in the range of 80 mmHg to 89 mmHg] are randomized to one of two intervention groups in a 1:1 ratio: Tai Chi or aerobic exercise. BP monitoring methods of office blood pressure, ambulatory blood pressure monitoring (ABPM), and home blood pressure monitoring (HBPM) are used at the same time to detect BP in multiple dimensions. The primary outcome is the comparison of SBP change from baseline to 12 months in Tai Chi group and SBP change from baseline to 12 months in aerobic exercise group. The secondary endpoints are as following: (1) the comparison of DBP of office blood pressure change from baseline to 12 months between Tai Chi group and aerobic exercise group, (2) the comparison of BP and the variability of BP assessed through ABPM change from baseline to 12 months between Tai Chi group and aerobic exercise group, (3) the comparison of BP assessed through HBPM change from baseline to 12 months between Tai Chi group and aerobic exercise group.DiscussionThis will be the first randomized controlled trial to specifically study the benefits of Tai Chi on the blood pressure control in patients with prehypertension. The successful completion of this study will help to provide evidence for whether Tai Chi is more desirable than aerobic exercise.Trial registrationTrial registration number: Chinese Clinical Trial Registry, ChiCTR1900024368. Registered on 7 July 2019, http://www.chictr.org.cn/edit.aspx?pid=39478&htm=4.

Project description:BackgroundPrevious research has suggested that tai chi offers a therapeutic benefit in patients with fibromyalgia.MethodsWe conducted a single-blind, randomized trial of classic Yang-style tai chi as compared with a control intervention consisting of wellness education and stretching for the treatment of fibromyalgia (defined by American College of Rheumatology 1990 criteria). Sessions lasted 60 minutes each and took place twice a week for 12 weeks for each of the study groups. The primary end point was a change in the Fibromyalgia Impact Questionnaire (FIQ) score (ranging from 0 to 100, with higher scores indicating more severe symptoms) at the end of 12 weeks. Secondary end points included summary scores on the physical and mental components of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). All assessments were repeated at 24 weeks to test the durability of the response.ResultsOf the 66 randomly assigned patients, the 33 in the tai chi group had clinically important improvements in the FIQ total score and quality of life. Mean (+/-SD) baseline and 12-week FIQ scores for the tai chi group were 62.9+/-15.5 and 35.1+/-18.8, respectively, versus 68.0+/-11 and 58.6+/-17.6, respectively, for the control group (change from baseline in the tai chi group vs. change from baseline in the control group, -18.4 points; P<0.001). The corresponding SF-36 physical-component scores were 28.5+/-8.4 and 37.0+/-10.5 for the tai chi group versus 28.0+/-7.8 and 29.4+/-7.4 for the control group (between-group difference, 7.1 points; P=0.001), and the mental-component scores were 42.6+/-12.2 and 50.3+/-10.2 for the tai chi group versus 37.8+/-10.5 and 39.4+/-11.9 for the control group (between-group difference, 6.1 points; P=0.03). Improvements were maintained at 24 weeks (between-group difference in the FIQ score, -18.3 points; P<0.001). No adverse events were observed.ConclusionsTai chi may be a useful treatment for fibromyalgia and merits long-term study in larger study populations. (Funded by the National Center for Complementary and Alternative Medicine and others; ClinicalTrials.gov number, NCT00515008.)

Project description:Chronic obstructive pulmonary disease (COPD) is a chronic, progressively debilitating condition that is prevalent in the US and worldwide. Patients suffer from progressive dyspnea and exercise intolerance. Physical exercise is beneficial, but conventional pulmonary rehabilitation programs are underutilized. There remains a need for novel interventions that improve symptoms, quality-of-life, and functional capacity. Tai chi is an increasingly popular mind-body exercise that includes physical exercise, breathing training, mindful awareness, and stress management--components that are essential to the self-management of COPD. There are, however, limited data on the effectiveness of tai chi as a therapeutic intervention in this population.The Primary Aims are to evaluate the efficacy, safety, and feasibility of a 12-week tai chi program for patients with COPD. We utilize a randomized controlled trial design, with participants assigned in a 2:1 ratio to either a group tai chi program (N = 63) or a time/attention-matched education control (N = 31). Our primary outcomes are COPD-specific quality-of-life and exercise capacity. Secondary outcomes include dyspnea, mood, functional status, self-efficacy, and lung function. Cardiopulmonary exercise testing is done in a subset of patients (N = 50). To explore optimal training duration, a subgroup of patients in tai chi are randomly assigned to complete an additional 12 weeks training (total 24 weeks) (Exploratory Aim 1). To explore the impact of a simplified seated intervention including only a subset of tai chi's training components, a third randomly assigned group (N = 31) receives a 12- week mind-body breathing program (N = 31) (Exploratory Aim 2).Results of the BEAM study (Breathing, Education, Awareness, Movement) will provide preliminary evidence regarding the value of tai chi for improving quality of life and exercise capacity in patients with COPD, including information regarding optimal duration. They will also inform the feasibility and potential benefit of an alternative mind-body breathing intervention, and provide insight regarding how isolated mind-body exercise components contribute to the overall effects of tai chi. Should the results be positive, tai chi and related mind-body practices may offer a novel exercise option that is potentially accessible to a large proportion of patients with COPD.This trial is registered in Clinical Trials.gov, ID number NCT01551953. Date of Registration March 1 2012.

Project description:BackgroundFibromyalgia is characterized by chronic generalized pain, fatigue, sleep disorders and other symptoms. Physical exercise is recommended as the first choice of non-pharmacological therapy. Thus, the aim of this study is to evaluate the effectiveness and cost-effectiveness of modified Pilates exercises compared to aerobic exercises in the treatment of patients with fibromyalgia.MethodsIn this randomized controlled trial with blinded assessor, 98 patients who meet the fibromyalgia classification criteria of the American College of Rheumatology 2010, aged between 20 and 75 years, and with pain intensity greater than or equal to 3 points in the Pain Numerical Rating Scale, will be randomly divided into Aerobic Group (aerobic exercises on treadmills or stationary bikes) and Pilates Group (modified Pilates exercises), and treated twice a week for eight weeks on the Center for Excellence in Clinical Research in Physical Therapy at Universidade Cidade de São Paulo, Brazil. The following outcomes will be evaluated by a blinded assessor at baseline, eight weeks, six months, and 12 months after randomization: impact of fibromyalgia assessed by the Fibromyalgia Impact Questionnaire, pain intensity by the Pain Numerical Rating Scale, kinesiophobia by the Tampa Scale of Kinesiophobia, specific disability by the Patient-Specific Functional Scale, functional capacity by the 6-min Walk Test, quality of sleep by the Pittsburgh Sleep Quality Index, and health-related quality of life by EQ-5D-3L and SF-6D questionnaires.DiscussionIt is expected that the Pilates exercises will be more effective than aerobic exercises in improving clinical outcomes and that this improvement will be maintained over the medium to long term. This study aims to clarify whether the Pilates method can be incorporated into the clinical practice of physical therapists treating patients with fibromyalgia. The study will also provide information on which exercise will be most cost-effective, information that can be used by insurers and public health systems.Trial registrationThis study was prospectively registered at the Clinical Trials Registry (NCT03050606) in February 2017.

Project description:Background:The newly compiled Bafa Wubu of Tai Chi (Eight Methods and Five Footworks) is a fitness routine that has been developed in accordance with the appeal of the General Administration of Sport of China and promoted both in China and abroad. This paper aims to compare the differences in energy consumption and related parameters between the two types of Tai Chi. Methods:A total of 60 healthy participants were recruited; 37 males (aged 37.4?±?10.4?years) and 23 females (aged 31.9?±?12.8?years). The maximal exercise capacity of participants was measured at baseline. Then, they received Tai Chi training for 12-week and their energy metabolism was measured dynamically. Results:A set of the Bafa Wubu of Tai Chi requires approximately 3?min, while a set of 24 form simplified Tai Chi approximately 5?min and 40?s. The average oxygen uptake/kg (VO2/kg, 10.8?±?2.52?ml/kg/min vs. 12.9?±?2.59?ml/kg/min, P?=?0.000), the highest VO2/kg (19.3?±?6.03?ml/kg/min vs. 24.1?±?7.50?ml/kg/min, p?=?0.000, the average metabolic equivalent (METs,2.3?±?0.16 METs vs. 3.2?±?0.14 METs, p?=?0.000), the highest oxygen pulse (VO2/HR, 11.1?±?0.99?ml vs. 13.9?±?0.93?ml, p?=?0.000) and rate of perceived exertion (RPE, 10.7?±?0.70 vs. 1.3?±?0.62, p?=?0.000) gained immediately after Bafa Wubu of Tai Chi exercise were significantly lower than those in 24 form simplified Tai Chi; heart rate recovery (HRR,1.5?±?0.41 vs. 1.3?±?0.45, p?=?0.008) at 1?min after the practice was significantly higher than after the 24 form simplified Tai Chi. Meanwhile, the average heart rate (HR, 104.1?±?11.41?bpm vs. 105.7?±?9.68?bpm, p?=?0.696) and the highest respiratory quotient (RQ, 1.0?±?0.06 vs. 0.9?±?0.09, p?=?0.643) were not significantly different. The intensity of Tai Chi was described as the highest oxygen uptake of the participants when they performed the Tai Chi divided by their individual maximal oxygen uptake. Tai Chi intensity during Bafa Wubu of Tai Chi (50%?±?11.7% vs. 64%?±?12.5%) was significantly lower than during 24 form simplified Tai Chi. Conclusion:The newly compiled Bafa Wubu of Tai Chi is characterized by lower energy consumption than 24 form simplified Tai Chi. Trial registration:Ethics Committee of Sports Science Experiment, Beijing Sport University- 2018010H. Registered 19 June 2018.

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:BackgroundA majority of lung cancer patients are diagnosed at advanced stages. Although there is considerable evidence of the benefits of aerobic exercise and tai-chi for lung cancer patients, little is known about the comparative effectiveness of the 2 exercise modes in advanced lung cancer patients.ObjectivesTo explore the feasibility and preliminary effects of aerobic exercise and tai-chi interventions on survival and well-being among advanced lung cancer patients.MethodsIn an assessor-blinded, exploratory randomized controlled trial, 30 advanced lung cancer patients were randomized to an aerobic exercise group, a tai-chi group (both attending 12-week, twice-weekly supervised sessions), or a self-management control group (receiving written exercise guidelines). The primary outcomes focused on feasibility including intervention completion, exercise adherence, and adverse events, while the secondary outcomes addressed preliminary effects and included 1-year survival, cancer symptoms (Pittsburgh Sleep Quality Index, Hospital Anxiety and Depression Score, Brief Fatigue Inventory), quality of life (EORTC QLQ-C30, QLQ-LC13), physical performance (6-minute walk test, up-and-go, sit-to-stand, 1-leg standing), activity levels (actigraph), and circadian rhythms (salivary cortisol).ResultsIntervention feasibility was established with a satisfactory completion rate at post-intervention for the aerobic exercise group (80%) and the tai-chi group (78%). The tai-chi group attained higher adherence than the exercise group in terms of attendance in supervised sessions (89% vs 75% of scheduled classes) and self-practice (225% vs 87% of the prescribed amount). Higher adherence to self-practice in the tai-chi group remained at the 6-month follow-up (81% vs 38% of the prescribed amount). No adverse event as a result of the intervention was reported. Effect-related outcomes did not show statistically significant changes in any group, except an improvement post-intervention in the up-and-go (-2.26, 95% CI: -4.04, -0.48) and sit-to-stand tests (4.52, 95% CI: 2.19, 6.85) in the aerobic exercise group.ConclusionsThe findings support the feasibility of aerobic exercise and tai-chi interventions in advanced lung cancer patients. A future study with a larger sample from multiple sites is recommended to confirm the comparative effects of the 2 exercise interventions relative to the self-management group and to enhance the generalizability of the findings.

Project description:ImportancePrehypertension increases the risk of developing hypertension and other cardiovascular diseases. Early and effective intervention for patients with prehypertension is highly important.ObjectiveTo assess the efficacy of Tai Chi vs aerobic exercise in patients with prehypertension.Design, setting, and participantsThis prospective, single-blinded randomized clinical trial was conducted between July 25, 2019, and January 24, 2022, at 2 tertiary public hospitals in China. Participants included 342 adults aged 18 to 65 years with prehypertension, defined as systolic blood pressure (SBP) of 120 to 139 mm Hg and/or diastolic BP (DBP) of 80 to 89 mm Hg.InterventionsParticipants were randomized in a 1:1 ratio to a Tai Chi group (n = 173) or an aerobic exercise group (n = 169). Both groups performed four 60-minute supervised sessions per week for 12 months.Main outcomes and measuresThe primary outcome was SBP at 12 months obtained in the office setting. Secondary outcomes included SBP at 6 months and DBP at 6 and 12 months obtained in the office setting and 24-hour ambulatory BP at 12 months.ResultsOf the 1189 patients screened, 342 (mean [SD] age, 49.3 [11.9] years; 166 men [48.5%] and 176 women [51.5%]) were randomized to 1 of 2 intervention groups: 173 to Tai Chi and 169 to aerobic exercise. At 12 months, the change in office SBP was significantly different between groups by -2.40 (95% CI, -4.39 to -0.41) mm Hg (P = .02), with a mean (SD) change of -7.01 (10.12) mm Hg in the Tai Chi group vs -4.61 (8.47) mm Hg in the aerobic exercise group. The analysis of office SBP at 6 months yielded similar results (-2.31 [95% CI, -3.94 to -0.67] mm Hg; P = .006). Additionally, 24-hour ambulatory SBP (-2.16 [95% CI, -3.84 to -0.47] mm Hg; P = .01) and nighttime ambulatory SBP (-4.08 [95% CI, -6.59 to -1.57] mm Hg; P = .002) were significantly reduced in the Tai Chi group compared with the aerobic exercise group.Conclusions and relevanceIn this study including patients with prehypertension, a 12-month Tai Chi intervention was more effective than aerobic exercise in reducing SBP. These findings suggest that Tai Chi may help promote the prevention of cardiovascular disease in populations with prehypertension.Trial registrationChinese Clinical Trial Registry Identifier: ChiCTR1900024368.

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A novel comparative effectiveness study of Tai Chi versus aerobic exercise for fibromyalgia: study protocol for a randomized controlled trial.

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A novel comparative effectiveness study of Tai Chi versus aerobic exercise for fibromyalgia: study protocol for a randomized controlled trial.

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