FibromyalgiaFMExNCT01420640

Tai Chi and Aerobic Exercise for Fibromyalgia (FMEx)

A study testing Lower frequency, shorter period of Tai Chi, Higher frequency, shorter period of Tai Chi and Shorter frequency, longer period of Tai Chi in people with Fibromyalgia, run by Tufts Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Fibromyalgia
What is being tested?: Lower frequency, shorter period of Tai Chi, Higher frequency, shorter period of Tai Chi and Shorter frequency, longer period of Tai Chi
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 224 participants
Where: 1 siteUnited States
Study dates: Jan 2012to Nov 2015
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Tufts Medical Center
Boston, Massachusetts, 02111

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Fibromyalgia
Being tested: Lower frequency, shorter period of Tai Chi, Higher frequency, shorter period of Tai Chi, Shorter frequency, longer period of Tai Chi, Higher frequency, longer period of Tai Chi, Aerobic Exercise Training
Keywords: Fibromyalgia, Tai Chi, mind-body exercise, aerobic exercise, exercise, pain
Medical subject headings: Fibromyalgia, Motor Activity, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01420640
Study group	Role	What they receive
Tai Chi	Active comparator	Not described Receives: 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	Not described Receives: Behavioral: Aerobic Exercise Training

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Week 0, Week 24

Secondary outcomes (16)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Nov 2015

First posted19 Aug 2011 (estimated)
Study startJan 2012
Primary completionNov 2015
Study completionNov 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (7)Papers the sponsor has linked to this study.
Other trials for FibromyalgiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 224 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01420640
Sponsor's protocol ID: 1R01AT006367-01A1
Other IDs: 1R01AT006367-01A1
Acronym: FMEx
Status last verified: Feb 2016
First submitted: 18 Aug 2011
Last updated: 10 Feb 2016
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 15006825
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.
PubMed 15741197
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.
PubMed 19877092
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.
PubMed 20818876
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.
PubMed 34419131
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.
PubMed 29563100
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.
PubMed 25633475

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tai Chi and Aerobic Exercise for Fibromyalgia
ClinicalTrials.gov ID: NCT01420640
Acronym / sponsor ID: FMEx / 1R01AT006367-01A1
Conditions: Fibromyalgia
Keywords: Fibromyalgia, Tai Chi, mind-body exercise, aerobic exercise, exercise, pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 224 participants (actual)
Lead sponsor: Tufts Medical CenterUniversity, hospital or other
Collaborators: National Center for Complementary and Integrative Health (NCCIH)
Study start: Jan 2012
Primary completion: Nov 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 19 Aug 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
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

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lower frequency, shorter period of Tai Chi12 weeks of supervised Tai Chi classes, 1x/week	Behavioural	Tai Chi
Higher frequency, shorter period of Tai Chi12 weeks of supervised Tai Chi classes, 2x/week	Behavioural	Tai Chi
Shorter frequency, longer period of Tai Chi24 weeks of supervised Tai Chi classes, 1x/week	Behavioural	Tai Chi
Higher frequency, longer period of Tai Chi24 weeks of supervised Tai Chi classes, 2x/week	Behavioural	Tai Chi
Aerobic Exercise Training24 weeks of supervised aerobic exercise training, 2x/week	Behavioural	Aerobic Exercise Training

Primary outcome

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

16 secondary outcomes

Change in Fibromyalgia Impact Questionnaire at follow-up
Time frame: Week 0, Week 12, Week 52
FM Symptom Severity Scale
Time frame: Week 0, Week 12, Week 24, Week 52
Body Mass Index (BMI)
Time frame: 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
Patient Global Assessment
Time frame: Week 0, Week 12, Week 24, Week 52
The Beck Depression Inventory II
Time frame: 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
The Pittsburg Sleep Quality Index (PSQI)
Time frame: 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
6-Minute Walk
Time frame: Week 0, Week 12, Week 24, Week 52
The Chair Stand Test
Time frame: Week 0, Week 12, Week 24, Week 52
The brief Outcome Expectation Scale (OES)
Time frame: Week 0, Week 12, Week 24, Week 52
Health Assessment Questionnaire (HAQ)
Time frame: Week 0, Week 12, Week 24, Week 52
PROMIS Health Assessment Questionnaire (HAQ)
Time frame: Week 0, Week 12, Week 24, Week 52
Muscle Strength/Power and Balance
Time frame: Week 0, Week 12, Week 24, Week 52
CHAMPS Activities Questionnaire for Older Adults
Time frame: Week 0, Week 12, Week 24, Week 52

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2016.
Background: PubMed 15006825Wang 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.
Background: PubMed 15741197Wang 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.
Background: PubMed 19877092Wang 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.
Background: PubMed 20818876Wang 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.
Derived from this study: PubMed 34419131Park 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.
Derived from this study: PubMed 29563100Wang 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.
Derived from this study: PubMed 25633475Wang 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chenchen Wang, MD, MSc principal investigator

Tufts Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Fibromyalgia Impact Questionnaire (FIQ) from baseline to 24 weeks (time frame: Week 0, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01420640, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2016.