Tai Chi and Aerobic Exercise for Fibromyalgia (FMEx)

NCT01420640 | Completed DMC

• 1 other identifier: 1R01AT006367-01A1
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia; Tai Chi; mind-body exercise; aerobic exercise; exercise; pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Change in Fibromyalgia Impact Questionnaire at follow-up

  Week 0, Week 12, Week 52

• FM Symptom Severity Scale

  Week 0, Week 12, Week 24, Week 52

• Body Mass Index (BMI)

  Week 0, Week 12, Week 24, Week 52

• Medical Outcome Study Short Form 36 (SF-36)

  Week 0, Week 12, Week 24, Week 52

• Patient Global Assessment

  Week 0, Week 12, Week 24, Week 52

Study Arms (2)

Tai Chi

ACTIVE COMPARATOR

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

Aerobic Exercise Training

ACTIVE COMPARATOR

Behavioral: Aerobic Exercise Training

Interventions

Lower frequency, shorter period of Tai Chi BEHAVIORAL

12 weeks of supervised Tai Chi classes, 1x/week

Tai Chi

Higher frequency, shorter period of Tai Chi BEHAVIORAL

12 weeks of supervised Tai Chi classes, 2x/week

Tai Chi

Shorter frequency, longer period of Tai Chi BEHAVIORAL

24 weeks of supervised Tai Chi classes, 1x/week

Tai Chi

Higher frequency, longer period of Tai Chi BEHAVIORAL

24 weeks of supervised Tai Chi classes, 2x/week

Tai Chi

Aerobic Exercise Training BEHAVIORAL

24 weeks of supervised aerobic exercise training, 2x/week

Aerobic Exercise Training

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts Medical Center: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (7)

• 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.

  PMID: 15006825 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.

  PMID: 15741197 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.

  PMID: 19877092 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.

  PMID: 20818876 BACKGROUND

• 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.

  PMID: 34419131 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.

  PMID: 29563100 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.

  PMID: 25633475 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Motor Activity; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Chenchen Wang, MD, MSc

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: August 19, 2011
• Study Start: January 1, 2012
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 10, 2016

Record last verified: 2016-02

Locations

US (1)