Tai Chi and Aerobic Exercise for Fibromyalgia (FMEx)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Tai Chi and Aerobic Exercise for Fibromyalgia

Conditions
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Fibromyalgia

Intervention / Treatment
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* Behavioral: Lower frequency, shorter period of Tai Chi
* Behavioral: Higher frequency, shorter period of Tai Chi
* Behavioral: Shorter frequency, longer period of Tai Chi
* Behavioral: Higher frequency, longer period of Tai Chi
* Behavioral: Aerobic Exercise Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tai Chi<br> | Behavioral: Lower frequency, shorter period of Tai Chi<br>* 12 weeks of supervised Tai Chi classes, 1x/week<br>Behavioral: Higher frequency, shorter period of Tai Chi<br>* 12 weeks of supervised Tai Chi classes, 2x/week<br>Behavioral: Shorter frequency, longer period of Tai Chi<br>* 24 weeks of supervised Tai Chi classes, 1x/week<br>Behavioral: Higher frequency, longer period of Tai Chi<br>* 24 weeks of supervised Tai Chi classes, 2x/week<br>|
| Active Comparator: Aerobic Exercise Training<br> | Behavioral: Aerobic Exercise Training<br>* 24 weeks of supervised aerobic exercise training, 2x/week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fibromyalgia Impact Questionnaire (FIQ) from baseline to 24 weeks | Overall severity of FM, intensity of pain, physical function, fatigue, morning tiredness, depression, anxiety, job difficulty, and overall well-being | Week 0, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fibromyalgia Impact Questionnaire at follow-up | Overall severity of FM, intensity of pain, physical function, fatigue, morning tiredness, depression, anxiety, job difficulty, and overall well-being | Week 0, Week 12, Week 52 | 
| FM Symptom Severity Scale | FM symptoms | Week 0, Week 12, Week 24, Week 52 | 
| Body Mass Index (BMI) | General health | Week 0, Week 12, Week 24, Week 52 | 
| Medical Outcome Study Short Form 36 (SF-36) | General health/functional status | Week 0, Week 12, Week 24, Week 52 | 
| Patient Global Assessment | General health/functional status | Week 0, Week 12, Week 24, Week 52 | 
| The Beck Depression Inventory II | Depression | Week 0, Week 12, Week 24, Week 52 | 
| The Chronic Pain Self-Efficacy Scale (CPSS) | Chronic pain | Week 0, Week 12, Week 24, Week 52 | 
| The Pittsburg Sleep Quality Index (PSQI) | Sleep quality | Week 0, Week 12, Week 24, Week 52 | 
| The Sleep Quality Numeric Rating Scale (NRS) | Sleep quality | Week 0, Week 12, Week 24, Week 52 | 
| 6-Minute Walk | Walking ability and Endurance | Week 0, Week 12, Week 24, Week 52 | 
| The Chair Stand Test | Physical functioning | Week 0, Week 12, Week 24, Week 52 | 
| The brief Outcome Expectation Scale (OES) | Outcome expectations | Week 0, Week 12, Week 24, Week 52 | 
| Health Assessment Questionnaire (HAQ) | Healthcare cost and utilization | Week 0, Week 12, Week 24, Week 52 | 
| PROMIS Health Assessment Questionnaire (HAQ) | Health status | Week 0, Week 12, Week 24, Week 52 | 
| Muscle Strength/Power and Balance | Physical functioning as assessed by muscle strength and power, and balance | Week 0, Week 12, Week 24, Week 52 | 
| CHAMPS Activities Questionnaire for Older Adults | Activity levels | Week 0, Week 12, Week 24, Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, Tai Chi, mind-body exercise, aerobic exercise, exercise, pain