Tai Chi and Aerobic Exercise for Fibromyalgia (FMEx)

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.

Inclusion Criteria:

- Age 21 years or older.

- Fulfills the American College of Rheumatology (ACR) 1990 classification criteria for
FM: (1) a history of widespread musculoskeletal pain on the right and left sides of
the body as well as above and below the waist for a minimum duration of 3 months, and
(2) pain in 11 or more of 18 specific tender points with moderate or greater
tenderness reported upon digital palpation.27

- Fulfills the ACR 2010 diagnostic criteria for FM: (WPI ≥7 AND SS ≥5) OR (WPI 3-6 AND
SS ≥9) and does not have a disorder that would otherwise explain the pain28

- Willing to complete the 12-week or 24-week study, including once or twice-a-week
exercise sessions.

- Willing to abstain from Tai Chi or other new formalized exercise programs until
completion of the study if randomized to the Aerobic Exercise.

- Willing to abstain from Aerobic Exercise or other new formalized exercise programs
until completion of the study if randomized to Tai Chi

Exclusion Criteria:

- Prior experience with Tai Chi or other similar types of Complementary and Alternative
Medicine in the past 1 year such as Qi gong and yoga since these share some of the
principles of Tai Chi.

- Dementia, neurological disease, cancer, cardiovascular disease, pulmonary disease,
metabolic disease, renal disease, liver disease, or other serious medical conditions
limiting ability to participate in the Tai Chi or Aerobic Exercise programs, as
determined by the study physicians.

- Any other diagnosed medical condition known to contribute to FM symptomatology that
is not under adequate control for the study period such as thyroid disease,
inflammatory arthritis, systemic lupus erythematosus, rheumatoid arthritis, myositis,
vasculitis or Sjogren's syndrome.

- Inability to pass the Mini-Mental Status examination (with a score below 24) 29

- Enrollment in any other clinical trial within the last 30 days

- Plan to permanently relocate from the region during the trial period

- Positive urine pregnancy test at baseline or planning pregnancy within the study
period

- Not English-Speaking: English is the only language to be used during the exercise
training program. Our self-reported outcome measures are obtained from validated
English-version questionnaires. In addition, using other languages would likely
require separate classes, recruitment and instructors which are beyond our current
study scope