Tai Chi and Aerobic Exercise for Fibromyalgia (FMEx)

This study is currently recruiting participants.
Verified December 2013 by Tufts Medical Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT01420640
First received: August 18, 2011
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Fibromyalgia
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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Tai Chi and Aerobic Exercise for Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • Change in Fibromyalgia Impact Questionnaire (FIQ) from baseline to 24 weeks [ Time Frame: Week 0, Week 24 ] [ Designated as safety issue: No ]
    Overall severity of FM, intensity of pain, physical function, fatigue, morning tiredness, depression, anxiety, job difficulty, and overall well-being


Secondary Outcome Measures:
  • Change in Fibromyalgia Impact Questionnaire at follow-up [ Time Frame: Week 0, Week 12, Week 52 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    FM symptoms

  • Body Mass Index (BMI) [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    General health

  • Medical Outcome Study Short Form 36 (SF-36) [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    General health/functional status

  • Patient Global Assessment [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    General health/functional status

  • The Beck Depression Inventory II [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Depression

  • The Chronic Pain Self-Efficacy Scale (CPSS) [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Chronic pain

  • The Pittsburg Sleep Quality Index (PSQI) [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Sleep quality

  • The Sleep Quality Numeric Rating Scale (NRS) [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Sleep quality

  • 6-Minute Walk [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Walking ability and Endurance

  • The Chair Stand Test [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Physical functioning

  • The brief Outcome Expectation Scale (OES) [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Outcome expectations

  • Health Assessment Questionnaire (HAQ) [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Healthcare cost and utilization

  • PROMIS Health Assessment Questionnaire (HAQ) [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    Health status

  • Muscle Strength/Power and Balance [ Time Frame: Week 0, Week 12, Week 24, Week 52 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Activity levels


Estimated Enrollment: 216
Study Start Date: January 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tai Chi 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
Active Comparator: Aerobic Exercise Training Behavioral: Aerobic Exercise Training
24 weeks of supervised aerobic exercise training, 2x/week

Detailed 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01420640

Contacts
Contact: Anna Schmid, BS 617-636-2676 aschmid@tuftsmedicalcenter.org
Contact: Chenchen Wang, MD, MSc 617-636-3251 cwang2@tuftsmedicalcenter.org

Locations
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Anna Schmid, BS    617-636-8682    fmex@tuftsmedicalcenter.org   
Sponsors and Collaborators
Tufts Medical Center
Investigators
Principal Investigator: Chenchen Wang, MD, MSc Tufts Medical Center
  More Information

Publications:
Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT01420640     History of Changes
Other Study ID Numbers: 1-R01 AT006367-01A1, 1R01AT006367-01A1
Study First Received: August 18, 2011
Last Updated: December 9, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts Medical Center:
Fibromyalgia
Tai Chi
mind-body exercise
aerobic exercise
exercise
pain

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 14, 2014