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Tai Chi and Aerobic Exercise for Fibromyalgia (FMEx) (FMEx)

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ClinicalTrials.gov Identifier: NCT01420640
Recruitment Status : Completed
First Posted : August 19, 2011
Last Update Posted : February 10, 2016
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Tufts Medical Center

August 18, 2011
August 19, 2011
February 10, 2016
January 2012
November 2015   (Final data collection date for primary outcome measure)
Change in Fibromyalgia Impact Questionnaire (FIQ) from baseline to 24 weeks [ Time Frame: Week 0, Week 24 ]
Overall severity of FM, intensity of pain, physical function, fatigue, morning tiredness, depression, anxiety, job difficulty, and overall well-being
Same as current
Complete list of historical versions of study NCT01420640 on ClinicalTrials.gov Archive Site
  • Change in Fibromyalgia Impact Questionnaire at follow-up [ Time Frame: Week 0, Week 12, Week 52 ]
    Overall severity of FM, intensity of pain, physical function, fatigue, morning tiredness, depression, anxiety, job difficulty, and overall well-being
  • FM Symptom Severity Scale [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    FM symptoms
  • Body Mass Index (BMI) [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    General health
  • Medical Outcome Study Short Form 36 (SF-36) [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    General health/functional status
  • Patient Global Assessment [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    General health/functional status
  • The Beck Depression Inventory II [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Depression
  • The Chronic Pain Self-Efficacy Scale (CPSS) [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Chronic pain
  • The Pittsburg Sleep Quality Index (PSQI) [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Sleep quality
  • The Sleep Quality Numeric Rating Scale (NRS) [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Sleep quality
  • 6-Minute Walk [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Walking ability and Endurance
  • The Chair Stand Test [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Physical functioning
  • The brief Outcome Expectation Scale (OES) [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Outcome expectations
  • Health Assessment Questionnaire (HAQ) [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Healthcare cost and utilization
  • PROMIS Health Assessment Questionnaire (HAQ) [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Health status
  • Muscle Strength/Power and Balance [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Physical functioning as assessed by muscle strength and power, and balance
  • CHAMPS Activities Questionnaire for Older Adults [ Time Frame: Week 0, Week 12, Week 24, Week 52 ]
    Activity levels
Same as current
Not Provided
Not Provided
 
Tai Chi and Aerobic Exercise for Fibromyalgia (FMEx)
Tai Chi and Aerobic Exercise for Fibromyalgia
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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Fibromyalgia
  • Behavioral: Lower frequency, shorter period of Tai Chi
    12 weeks of supervised Tai Chi classes, 1x/week
  • Behavioral: Higher frequency, shorter period of Tai Chi
    12 weeks of supervised Tai Chi classes, 2x/week
  • Behavioral: Shorter frequency, longer period of Tai Chi
    24 weeks of supervised Tai Chi classes, 1x/week
  • Behavioral: Higher frequency, longer period of Tai Chi
    24 weeks of supervised Tai Chi classes, 2x/week
  • Behavioral: Aerobic Exercise Training
    24 weeks of supervised aerobic exercise training, 2x/week
  • Active Comparator: Tai Chi
    Interventions:
    • 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
  • Active Comparator: Aerobic Exercise Training
    Intervention: Behavioral: Aerobic Exercise Training

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
224
216
November 2015
November 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01420640
1R01AT006367-01A1( U.S. NIH Grant/Contract )
1R01AT006367-01A1 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Tufts Medical Center
Tufts Medical Center
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Chenchen Wang, MD, MSc Tufts Medical Center
Tufts Medical Center
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP