An interventional study of Lower frequency, shorter period of Tai Chi and Higher frequency, shorter period of Tai Chi in Fibromyalgia, sponsored by Tufts Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2016-02-10.
Sponsored by Tufts Medical Center · Not applicable, Interventional, and Treatment
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.
1,336 studies on the registry are indexed under Fibromyalgia; 266 are open to participants now.
This study's enrollment of 224 is above the median of 60 across 1,035 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Tufts Medical Center is the lead sponsor of 194 studies on the registry; 28 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 16 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
12 weeks of supervised Tai Chi classes, 1x/week
12 weeks of supervised Tai Chi classes, 2x/week
24 weeks of supervised Tai Chi classes, 1x/week
24 weeks of supervised Tai Chi classes, 2x/week
24 weeks of supervised aerobic exercise training, 2x/week
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
Time frame: Week 0, Week 24
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
Time frame: Week 0, Week 12, Week 52
FM Symptom Severity Scale
FM symptoms
Time frame: Week 0, Week 12, Week 24, Week 52
Body Mass Index (BMI)
General health
Time frame: Week 0, Week 12, Week 24, Week 52
Medical Outcome Study Short Form 36 (SF-36)
General health/functional status
Time frame: Week 0, Week 12, Week 24, Week 52
Patient Global Assessment
General health/functional status
Time frame: Week 0, Week 12, Week 24, Week 52
The Beck Depression Inventory II
Depression
Time frame: Week 0, Week 12, Week 24, Week 52
The Chronic Pain Self-Efficacy Scale (CPSS)
Chronic pain
Time frame: Week 0, Week 12, Week 24, Week 52
The Pittsburg Sleep Quality Index (PSQI)
Sleep quality
Time frame: Week 0, Week 12, Week 24, Week 52
The Sleep Quality Numeric Rating Scale (NRS)
Sleep quality
Time frame: Week 0, Week 12, Week 24, Week 52
6-Minute Walk
Walking ability and Endurance
Time frame: Week 0, Week 12, Week 24, Week 52
The Chair Stand Test
Physical functioning
Time frame: Week 0, Week 12, Week 24, Week 52
The brief Outcome Expectation Scale (OES)
Outcome expectations
Time frame: Week 0, Week 12, Week 24, Week 52
Health Assessment Questionnaire (HAQ)
Healthcare cost and utilization
Time frame: Week 0, Week 12, Week 24, Week 52
PROMIS Health Assessment Questionnaire (HAQ)
Health status
Time frame: Week 0, Week 12, Week 24, Week 52
Muscle Strength/Power and Balance
Physical functioning as assessed by muscle strength and power, and balance
Time frame: Week 0, Week 12, Week 24, Week 52
CHAMPS Activities Questionnaire for Older Adults
Activity levels
Time frame: Week 0, Week 12, Week 24, Week 52
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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