Tai Chi and Aerobic Exercise for Fibromyalgia (FMEx)

Fibromyalgia Clinical Trial

— FMEx  

Official title:

Tai Chi and Aerobic Exercise for Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01420640
• Other study ID #: 1R01AT006367-01A1
• Secondary ID: 1R01AT006367-01A
• Status: Completed
• Phase: N/A
• First received: August 18, 2011
• Last updated: February 9, 2016
• Start date: January 2012
• Est. completion date: November 2015

Study information

• Verified date: February 2016
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• Lower frequency, shorter period of Tai Chi
12 weeks of supervised Tai Chi classes, 1x/week
• Higher frequency, shorter period of Tai Chi
12 weeks of supervised Tai Chi classes, 2x/week
• Shorter frequency, longer period of Tai Chi
24 weeks of supervised Tai Chi classes, 1x/week
• Higher frequency, longer period of Tai Chi
24 weeks of supervised Tai Chi classes, 2x/week
• Aerobic Exercise Training
24 weeks of supervised aerobic exercise training, 2x/week

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. Review. — View Citation

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. Epub 2005 Mar 1. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	FM Symptom Severity Scale	FM symptoms	Week 0, Week 12, Week 24, Week 52	No
Secondary	Body Mass Index (BMI)	General health	Week 0, Week 12, Week 24, Week 52	No
Secondary	Medical Outcome Study Short Form 36 (SF-36)	General health/functional status	Week 0, Week 12, Week 24, Week 52	No
Secondary	Patient Global Assessment	General health/functional status	Week 0, Week 12, Week 24, Week 52	No
Secondary	The Beck Depression Inventory II	Depression	Week 0, Week 12, Week 24, Week 52	No
Secondary	The Chronic Pain Self-Efficacy Scale (CPSS)	Chronic pain	Week 0, Week 12, Week 24, Week 52	No
Secondary	The Pittsburg Sleep Quality Index (PSQI)	Sleep quality	Week 0, Week 12, Week 24, Week 52	No
Secondary	The Sleep Quality Numeric Rating Scale (NRS)	Sleep quality	Week 0, Week 12, Week 24, Week 52	No
Secondary	6-Minute Walk	Walking ability and Endurance	Week 0, Week 12, Week 24, Week 52	No
Secondary	The Chair Stand Test	Physical functioning	Week 0, Week 12, Week 24, Week 52	No
Secondary	The brief Outcome Expectation Scale (OES)	Outcome expectations	Week 0, Week 12, Week 24, Week 52	No
Secondary	Health Assessment Questionnaire (HAQ)	Healthcare cost and utilization	Week 0, Week 12, Week 24, Week 52	No
Secondary	PROMIS Health Assessment Questionnaire (HAQ)	Health status	Week 0, Week 12, Week 24, Week 52	No
Secondary	Muscle Strength/Power and Balance	Physical functioning as assessed by muscle strength and power, and balance	Week 0, Week 12, Week 24, Week 52	No
Secondary	CHAMPS Activities Questionnaire for Older Adults	Activity levels	Week 0, Week 12, Week 24, Week 52	No