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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AT006367-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tai Chi | Active Comparator |
| |
| Aerobic Exercise Training | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lower frequency, shorter period of Tai Chi | Behavioral | 12 weeks of supervised Tai Chi classes, 1x/week |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chenchen Wang, MD, MSc | Tufts Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15006825 | Background | Wang C, Collet JP, Lau J. The effect of Tai Chi on health outcomes in patients with chronic conditions: a systematic review. Arch Intern Med. 2004 Mar 8;164(5):493-501. doi: 10.1001/archinte.164.5.493. | |
| 15741197 | Background | Wang C, Roubenoff R, Lau J, Kalish R, Schmid CH, Tighiouart H, Rones R, Hibberd PL. Effect of Tai Chi in adults with rheumatoid arthritis. Rheumatology (Oxford). 2005 May;44(5):685-7. doi: 10.1093/rheumatology/keh572. Epub 2005 Mar 1. No abstract available. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| D009043 | Motor Activity |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| Higher frequency, shorter period of Tai Chi | Behavioral | 12 weeks of supervised Tai Chi classes, 2x/week |
|
| Shorter frequency, longer period of Tai Chi | Behavioral | 24 weeks of supervised Tai Chi classes, 1x/week |
|
| Higher frequency, longer period of Tai Chi | Behavioral | 24 weeks of supervised Tai Chi classes, 2x/week |
|
| Aerobic Exercise Training | Behavioral | 24 weeks of supervised aerobic exercise training, 2x/week |
|
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 |
| 19877092 | Background | Wang C, Schmid CH, Hibberd PL, Kalish R, Roubenoff R, Rones R, McAlindon T. Tai Chi is effective in treating knee osteoarthritis: a randomized controlled trial. Arthritis Rheum. 2009 Nov 15;61(11):1545-53. doi: 10.1002/art.24832. |
| 20818876 | Background | Wang C, Schmid CH, Rones R, Kalish R, Yinh J, Goldenberg DL, Lee Y, McAlindon T. A randomized trial of tai chi for fibromyalgia. N Engl J Med. 2010 Aug 19;363(8):743-54. doi: 10.1056/NEJMoa0912611. |
| 34419131 | Derived | Park M, Bannuru RR, Price LL, Harvey WF, Driban JB, Wang C. Effective recruitment strategies in an exercise trial for patients with fibromyalgia. Trials. 2021 Aug 21;22(1):557. doi: 10.1186/s13063-021-05502-3. |
| 29563100 | Derived | Wang C, Schmid CH, Fielding RA, Harvey WF, Reid KF, Price LL, Driban JB, Kalish R, Rones R, McAlindon T. Effect of tai chi versus aerobic exercise for fibromyalgia: comparative effectiveness randomized controlled trial. BMJ. 2018 Mar 21;360:k851. doi: 10.1136/bmj.k851. |
| 25633475 | Derived | Wang C, McAlindon T, Fielding RA, Harvey WF, Driban JB, Price LL, Kalish R, Schmid A, Scott TM, Schmid CH. A novel comparative effectiveness study of Tai Chi versus aerobic exercise for fibromyalgia: study protocol for a randomized controlled trial. Trials. 2015 Jan 30;16:34. doi: 10.1186/s13063-015-0548-x. |
| D009422 |
| Nervous System Diseases |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |