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

February 9, 2016 updated by: Tufts Medical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

224

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 0, Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 0, Week 12, Week 52
FM Symptom Severity Scale
Time Frame: Week 0, Week 12, Week 24, Week 52
FM symptoms
Week 0, Week 12, Week 24, Week 52
Body Mass Index (BMI)
Time Frame: Week 0, Week 12, Week 24, Week 52
General health
Week 0, Week 12, Week 24, Week 52
Medical Outcome Study Short Form 36 (SF-36)
Time Frame: Week 0, Week 12, Week 24, Week 52
General health/functional status
Week 0, Week 12, Week 24, Week 52
Patient Global Assessment
Time Frame: Week 0, Week 12, Week 24, Week 52
General health/functional status
Week 0, Week 12, Week 24, Week 52
The Beck Depression Inventory II
Time Frame: Week 0, Week 12, Week 24, Week 52
Depression
Week 0, Week 12, Week 24, Week 52
The Chronic Pain Self-Efficacy Scale (CPSS)
Time Frame: Week 0, Week 12, Week 24, Week 52
Chronic pain
Week 0, Week 12, Week 24, Week 52
The Pittsburg Sleep Quality Index (PSQI)
Time Frame: Week 0, Week 12, Week 24, Week 52
Sleep quality
Week 0, Week 12, Week 24, Week 52
The Sleep Quality Numeric Rating Scale (NRS)
Time Frame: Week 0, Week 12, Week 24, Week 52
Sleep quality
Week 0, Week 12, Week 24, Week 52
6-Minute Walk
Time Frame: Week 0, Week 12, Week 24, Week 52
Walking ability and Endurance
Week 0, Week 12, Week 24, Week 52
The Chair Stand Test
Time Frame: Week 0, Week 12, Week 24, Week 52
Physical functioning
Week 0, Week 12, Week 24, Week 52
The brief Outcome Expectation Scale (OES)
Time Frame: Week 0, Week 12, Week 24, Week 52
Outcome expectations
Week 0, Week 12, Week 24, Week 52
Health Assessment Questionnaire (HAQ)
Time Frame: Week 0, Week 12, Week 24, Week 52
Healthcare cost and utilization
Week 0, Week 12, Week 24, Week 52
PROMIS Health Assessment Questionnaire (HAQ)
Time Frame: Week 0, Week 12, Week 24, Week 52
Health status
Week 0, Week 12, Week 24, Week 52
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
Week 0, Week 12, Week 24, Week 52
CHAMPS Activities Questionnaire for Older Adults
Time Frame: Week 0, Week 12, Week 24, Week 52
Activity levels
Week 0, Week 12, Week 24, Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts Medical Center

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

August 18, 2011

First Submitted That Met QC Criteria

August 18, 2011

First Posted (Estimate)

August 19, 2011

Study Record Updates

Last Update Posted (Estimate)

February 10, 2016

Last Update Submitted That Met QC Criteria

February 9, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01AT006367-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Fibromyalgia

Clinical Trials on Lower frequency, shorter period of Tai Chi

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe