Fibromyalgia Clinical Trial
Official title:
Tai Chi and Aerobic Exercise for Fibromyalgia
The investigators will conduct a large randomized controlled trial comparing the effectiveness of Tai Chi mind-body exercise and standard-of-care aerobic exercise for fibromyalgia. In addition, the investigators will determine the optimal frequency and duration of a Tai Chi intervention for short and long-term effectiveness.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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