Tai Chi and Aerobic Exercise for Fibromyalgia (FMEx)

• Change in Fibromyalgia Impact Questionnaire (FIQ) from baseline to 24 weeks [ Time Frame: Week 0, Week 24 ] [ Designated as safety issue: No ]
  Overall severity of FM, intensity of pain, physical function, fatigue, morning tiredness, depression, anxiety, job difficulty, and overall well-being
  
  

• Change in Fibromyalgia Impact Questionnaire at follow-up [ Time Frame: Week 0, Week 12, Week 52 ] [ Designated as safety issue: No ]
  Overall severity of FM, intensity of pain, physical function, fatigue, morning tiredness, depression, anxiety, job difficulty, and overall well-being
  
  
• FM Symptom Severity Scale [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
  FM symptoms
  
  
• Body Mass Index (BMI) [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
  General health
  
  
• Medical Outcome Study Short Form 36 (SF-36) [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
  General health/functional status
  
  
• Patient Global Assessment [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
  General health/functional status
  
  
• The Beck Depression Inventory II [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
  Depression
  
  
• The Chronic Pain Self-Efficacy Scale (CPSS) [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
  Chronic pain
  
  
• The Pittsburg Sleep Quality Index (PSQI) [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
  Sleep quality
  
  
• The Sleep Quality Numeric Rating Scale (NRS) [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
  Sleep quality
  
  
• 6-Minute Walk [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
  Walking ability and Endurance
  
  
• The Chair Stand Test [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
  Physical functioning
  
  
• The brief Outcome Expectation Scale (OES) [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
  Outcome expectations
  
  
• Health Assessment Questionnaire (HAQ) [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
  Healthcare cost and utilization
  
  
• PROMIS Health Assessment Questionnaire (HAQ) [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
  Health status
  
  
• Muscle Strength/Power and Balance [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
  Physical functioning as assessed by muscle strength and power, and balance
  
  
• CHAMPS Activities Questionnaire for Older Adults [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
  Activity levels
  
  

Fibromyalgia (FM) is a chronic musculoskeletal pain syndrome that causes substantial physical and psychological impairment and costs over $25 billion annually. Current pharmacological therapies may be expensive, cause serious adverse effects, and fail to effectively improve pain and function. Finding new and effective non-pharmacological treatments for FM patients is urgently needed.

We propose to conduct the first comparative effectiveness trial of Tai Chi vs. aerobic exercise (a recommended component of the current standard of care) and to evaluate effectiveness under different Tai Chi dosing schedules in a large FM population. We aim to (1) demonstrate that, compared to aerobic exercise, Tai Chi is a more effective intervention for managing the pain and improving the functional limitations that impact quality of life for FM patients, and 2) determine the optimal frequency and duration of a supervised Tai Chi intervention in relation to short and long-term effectiveness. To achieve this goal, we will conduct a single-blind, randomized controlled trial of Tai Chi vs. aerobic exercise in 216 patients who meet the American College of Rheumatology criteria for FM. Patients will be randomized to one of four Tai Chi intervention groups: 12 or 24 weeks of supervised Tai Chi given once or twice per week, or a supervised aerobic exercise control: 2x/week for 24 weeks. All groups will have a 52-week follow-up. The primary outcome will be the FM Impact Questionnaire total score at 24 weeks. Secondary outcomes include the measures of widespread pain, functional performance, psychological functioning, self-efficacy, sleep quality, and quality of life at 12, 24, and 52 weeks.

Successful completion of the proposed study will determine the ideal regimen of Tai Chi and demonstrate that Tai Chi can be a simple, effective, and durable treatment for this therapeutically challenging disorder.