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

Primary Purpose

Fibromyalgia

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Tai Chi, mind-body exercise, aerobic exercise, exercise, pain

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Tufts Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Tai Chi

Aerobic Exercise Training

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

FM Symptom Severity Scale

FM symptoms

Body Mass Index (BMI)

General health

Medical Outcome Study Short Form 36 (SF-36)

General health/functional status

Patient Global Assessment

General health/functional status

The Beck Depression Inventory II

Depression

The Chronic Pain Self-Efficacy Scale (CPSS)

Chronic pain

The Pittsburg Sleep Quality Index (PSQI)

Sleep quality

The Sleep Quality Numeric Rating Scale (NRS)

Sleep quality

6-Minute Walk

Walking ability and Endurance

The Chair Stand Test

Physical functioning

The brief Outcome Expectation Scale (OES)

Outcome expectations

Health Assessment Questionnaire (HAQ)

Healthcare cost and utilization

PROMIS Health Assessment Questionnaire (HAQ)

Health status

Muscle Strength/Power and Balance

Physical functioning as assessed by muscle strength and power, and balance

CHAMPS Activities Questionnaire for Older Adults

Activity levels

Full Information

NCT ID

NCT01420640

First Posted

August 18, 2011

Last Updated

February 9, 2016

Sponsor

Tufts Medical Center

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

1. Study Identification

Unique Protocol Identification Number

NCT01420640

Brief Title

Tai Chi and Aerobic Exercise for Fibromyalgia (FMEx)

Acronym

FMEx

Official Title

Tai Chi and Aerobic Exercise for Fibromyalgia

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

November 2015 (Actual)

Study Completion Date

November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tufts Medical Center

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia

Keywords

Fibromyalgia, Tai Chi, mind-body exercise, aerobic exercise, exercise, pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

224 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tai Chi

Arm Type

Active Comparator

Arm Title

Aerobic Exercise Training

Arm Type

Active Comparator

Intervention Type

Behavioral

Intervention Name(s)

Lower frequency, shorter period of Tai Chi

Intervention Description

12 weeks of supervised Tai Chi classes, 1x/week

Intervention Type

Behavioral

Intervention Name(s)

Higher frequency, shorter period of Tai Chi

Intervention Description

12 weeks of supervised Tai Chi classes, 2x/week

Intervention Type

Behavioral

Intervention Name(s)

Shorter frequency, longer period of Tai Chi

Intervention Description

24 weeks of supervised Tai Chi classes, 1x/week

Intervention Type

Behavioral

Intervention Name(s)

Higher frequency, longer period of Tai Chi

Intervention Description

24 weeks of supervised Tai Chi classes, 2x/week

Intervention Type

Behavioral

Intervention Name(s)

Aerobic Exercise Training

Intervention Description

24 weeks of supervised aerobic exercise training, 2x/week

Primary Outcome Measure Information:

Title

Change in Fibromyalgia Impact Questionnaire (FIQ) from baseline to 24 weeks

Description

Overall severity of FM, intensity of pain, physical function, fatigue, morning tiredness, depression, anxiety, job difficulty, and overall well-being

Time Frame

Week 0, Week 24

Secondary Outcome Measure Information:

Title

Change in Fibromyalgia Impact Questionnaire at follow-up

Description

Overall severity of FM, intensity of pain, physical function, fatigue, morning tiredness, depression, anxiety, job difficulty, and overall well-being

Time Frame

Week 0, Week 12, Week 52

Title

FM Symptom Severity Scale

Description

FM symptoms

Time Frame