title: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier: NCT01420640 , registered 18 August 2011.
authors: Center for Complementary and Integrative Medicine/Division of Rheumatology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA. CWang2@tuftsmedicalcenter.org.
authors: Chenchen
authors: C
authors: Wang
authors: Center for Complementary and Integrative Medicine/Division of Rheumatology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA. TMcalindon@tuftsmedicalcenter.org.
authors: Timothy
authors: T
authors: McAlindon
authors: Nutrition, Exercise Physiology, and Sarcopenia Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, USA. Roger.Fielding@tufts.edu.
authors: Roger A
authors: RA
authors: Fielding
authors: Center for Complementary and Integrative Medicine/Division of Rheumatology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA. WHarvey@tuftsmedicalcenter.org.
authors: William F
authors: WF
authors: Harvey
authors: Center for Complementary and Integrative Medicine/Division of Rheumatology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA. JDriban@tufts.edu.
authors: Jeffrey B
authors: JB
authors: Driban
authors: The Institute for Clinical Research and Health Policy Studies, Tufts Clinical and Translational Science Institute Tufts Medical Center, Tufts University, Boston, MA, USA. LPrice1@tuftsmedicalcenter.org.
authors: Lori Lyn
authors: LL
authors: Price
authors: Center for Complementary and Integrative Medicine/Division of Rheumatology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA. RKalish@tufts.medicalcenter.org.
authors: Robert
authors: R
authors: Kalish
authors: Center for Complementary and Integrative Medicine/Division of Rheumatology, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA. ASchmid@tuftsmedicalcenter.org.
authors: Anna
authors: A
authors: Schmid
authors: Neuroscience and Aging Laboratory, Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, Boston, USA. Tammy.Scott@tufts.edu.
authors: Tammy M
authors: TM
authors: Scott
authors: Department of Biostatistics and Center for Evidence Based Medicine, Brown University School of Public Health, Providence, RI, USA. Christopher_Schmid@brown.edu.
authors: Christopher H
authors: CH
authors: Schmid
mesh_terms: D000328:Adult; D002985:Clinical Protocols; D015444:Exercise; D005356:Fibromyalgia / Q000628:therapy*; D006801:Humans; D018401:Sample Size; D026302:Tai Ji; D016896:Treatment Outcome
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