FibromyalgiaNCT00321659
Optimizing Fibromyalgia Self-management
A study testing Aerobic, Strength training and Combination in people with Fibromyalgia, run by Beth Israel Deaconess Medical Center.
Trial summary
The overall objective of this work is to improve treatment outcomes for persons with fibromyalgia by optimizing the approach to self-management. The purpose of this research project is to evaluate and compare, in a randomized, controlled trial involving 200 women, the short and long-term effectiveness of four… Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Aerobic, Strength training and Combination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2002to 21 Sep 2005
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 25 to 75 years of age
- A confirmed diagnosis of FMS by a primary care physician (and rheumatologist if present) using the American College of Rheumatology criteria
- Currently under care for their FMS by a primary care physician or rheumatologist
- Determined to be medically stable by their primary care physician and capable of participation in a supervised program of low to moderate intensity exercise
- Willingness to commit to time and travel requirements of project
Who cannot join
- Do not fulfill ACR definition of FMS
- Presence of a concurrent condition that limits a person's ability to perform the exercise program (i.e., advanced RA or OA, recent MI)
- History of a positive exercise/stress test, or current cardiovascular, pulmonary, neurological, or renal disease where an exercise program is contraindicated
- Uncontrolled hypertension, diabetes, asthma, or heart failure
- Physician does not want his/her patient to participate for any reason
About this study
Official title: Short and Long-term Effects of Exercise and Education as Self-management in Women With Fibromyalgia
The overall objective of this work is to improve treatment outcomes for persons with fibromyalgia by optimizing the approach to self-management. The purpose of this research project is to evaluate and compare, in a randomized, controlled trial involving 200 women, the short and long-term effectiveness of four approaches to fibromyalgia self-management for improving health and functional status, self-efficacy, and symptom severity. Additionally, we will also examine the effect of each intervention on health care usage. We will assess the following 16-week interventions:
- cardiovascular and flexibility exercise
- strength training, cardiovascular and flexibility exercise
- Arthritis Foundation's Fibromyalgia Self-Help course
- a combination of the Fibromyalgia Self-Help Course and strength training exercise interventions
Read the detailed description
Fibromyalgia syndrome (FMS) is a common, chronic musculoskeletal disorder and a growing cause of disability and increased health care utilization. Current treatment focuses largely on pharmacological interventions, which are often ineffective at improving symptoms and functional status. Recent research suggests that disease self-management can be efficacious in the short-term at reducing symptom severity and improving function in persons with FMS. The most common forms of FMS self-management are coping skills training (behavioral/education) and exercise. Limited in number, most FMS self-management studies examine the short-term effects of one form or the other, with most using the coping skills training approach. Little data exist to examine the long-term effects of these interventions, the potential additive effect of combining coping skills training with a comprehensive, group exercise program or an approach for promoting long-term compliance of these interventions. The objective of this proposal is to identify the optimal approach to FMS self-management. The study is a randomized, controlled trial comparing coping skills training (the Arthritis Foundation Fibromyalgia Self-Help Course (FSHC)) with two exercise programs - cardiovascular and flexibility training with and without strength training - and a combination (the FSHC plus the strength training exercise program). Each intervention period will last 16 weeks and include group sessions led by trained personnel. Subjects will be followed for 6 months after completing the intervention to evaluate the short-term effect of each program. At 6 months, subjects will be randomized into two groups-one group will receive a 4 week refresher course of their original intervention every 6 months and the other group will receive no further intervention. Long-term follow up will be for 24 months after completing the 16 week intervention period. Subjects will include 200 women (four groups of 50), 25 to 65 years old with a confirmed diagnosis of FMS. Participants will undergo blinded assessment at the Beth Israel Deaconess Medical Center's GCRC at five time points-baseline, completion of the 16-week intervention and 6, 12 and 24 month follow up. We will assess health and functional status (FIQ, SF36), symptom severity (FIQ, SF36, Beck scales), self-efficacy (Arthritis Self-Efficacy Scale), fitness (muscle strength, cardiovascular fitness, flexibility) and health care utilization (direct and indirect costs). The study will improve treatment outcomes for persons with FMS by identifying the optimal self-management program.
- Conditions
- Fibromyalgia
- Being tested
- Aerobic, Strength training, Combination, FSHC
- Keywords
- fibromyalgia, self-management, exercise, patient education
- Medical subject headings
- Fibromyalgia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AerobicBehavioural
3x/week of walking and cycling
Strength trainingBehavioural
3x/week of resistance training activities
CombinationBehavioural
3x/week of aerobic and strength training activities
FSHCBehavioural
Also called Fibromyalgia Self-Help Course
Biweekly group education group meetings
| Study group | Role | What they receive |
|---|---|---|
| Aerobic and flexibility exercise | Experimental | 16 weeks of aerobic and flexibility exercise. Three days per week for 1 hour of walking and cycling. Receives: Behavioral: Aerobic |
| Strength, aerobic, and flexibility | Experimental | 16 weeks of strength training, aerobic, and flexibility exercise (ST) intervention; Receives: Behavioral: Strength training |
| Fibromyalgia Self-Help Course | Experimental | 7 weeks of FSHC behavior change education Receives: Behavioral: FSHC |
| a Combination of ST and FSHC | Experimental | 16 wks of a combination of ST and FSHC (ST-FSHC) exercise and behavior change education Receives: Behavioral: Combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire
Measured: Baseline, 16 wks and 10 months
Secondary outcomes (7)
SF36 subscales
Measured: Baseline, 16 wks and 10 months
Beck Depression Inventory
Measured: Baseline, 16 wks and 10 months
Beck Anxiety Inventory
Measured: Baseline, 16 wks and 10 months
6 minute Walk Test
Measured: Baseline, 16 wks and 10 months
1 Repetition Maximum Chest Press
Measured: Baseline, 16 wks and 10 months
1 Repetition Maximum Leg Press
Measured: Baseline, 16 wks and 10 months
Self Efficacy Scale
Measured: Baseline, 16 wks and 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2006 (estimated)
- Study start10 Oct 2002
- Primary completion21 Sep 2005
- Study completion21 Sep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Arthritis Foundation, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Daniel Rooks, Beth Israel Deaconess Medical Center
- Investigators
- Daniel S. Rooks, PhD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00321659
- Sponsor's protocol ID
- 2001P001769
- Other IDs
- K23AR048305
- Status last verified
- Mar 2017
- First submitted
- 3 May 2006
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan was prepared, as no data was to be shared.
Publications
Rooks DS, Silverman CB, Kantrowitz FG. The effects of progressive strength training and aerobic exercise on muscle strength and cardiovascular fitness in women with fibromyalgia: a pilot study. Arthritis Rheum. 2002 Feb;47(1):22-8. doi: 10.1002/art1.10180.
PubMed 11932874Rooks DS, Gautam S, Romeling M, Cross ML, Stratigakis D, Evans B, Goldenberg DL, Iversen MD, Katz JN. Group exercise, education, and combination self-management in women with fibromyalgia: a randomized trial. Arch Intern Med. 2007 Nov 12;167(20):2192-200. doi: 10.1001/archinte.167.20.2192.
PubMed 17998491
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long-term Effects of Exercise and Education as Self-management in Women With Fibromyalgia
- ClinicalTrials.gov ID
- NCT00321659
- Acronym / sponsor ID
- 2001P001769
- Conditions
- Fibromyalgia
- Keywords
- fibromyalgia, self-management, exercise, patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Arthritis Foundation, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 10 Oct 2002 (actual)
- Primary completion
- 21 Sep 2005 (actual)
- Study completion
- 21 Sep 2005 (actual)
- First posted
- 4 May 2006 (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.
The overall objective of this work is to improve treatment outcomes for persons with fibromyalgia by optimizing the approach to self-management. The purpose of this research project is to evaluate and compare, in a randomized, controlled trial involving 200 women, the short and long-term effectiveness of four approaches to fibromyalgia self-management for improving health and functional status, self-efficacy, and symptom severity. Additionally, we will also examine the effect of each intervention on health care usage. We will assess the following 16-week interventions:
- cardiovascular and flexibility exercise
- strength training, cardiovascular and flexibility exercise
- Arthritis Foundation's Fibromyalgia Self-Help course
- a combination of the Fibromyalgia Self-Help Course and strength training exercise interventions
Detailed description
Fibromyalgia syndrome (FMS) is a common, chronic musculoskeletal disorder and a growing cause of disability and increased health care utilization. Current treatment focuses largely on pharmacological interventions, which are often ineffective at improving symptoms and functional status. Recent research suggests that disease self-management can be efficacious in the short-term at reducing symptom severity and improving function in persons with FMS. The most common forms of FMS self-management are coping skills training (behavioral/education) and exercise. Limited in number, most FMS self-management studies examine the short-term effects of one form or the other, with most using the coping skills training approach. Little data exist to examine the long-term effects of these interventions, the potential additive effect of combining coping skills training with a comprehensive, group exercise program or an approach for promoting long-term compliance of these interventions. The objective of this proposal is to identify the optimal approach to FMS self-management. The study is a randomized, controlled trial comparing coping skills training (the Arthritis Foundation Fibromyalgia Self-Help Course (FSHC)) with two exercise programs - cardiovascular and flexibility training with and without strength training - and a combination (the FSHC plus the strength training exercise program). Each intervention period will last 16 weeks and include group sessions led by trained personnel. Subjects will be followed for 6 months after completing the intervention to evaluate the short-term effect of each program. At 6 months, subjects will be randomized into two groups-one group will receive a 4 week refresher course of their original intervention every 6 months and the other group will receive no further intervention. Long-term follow up will be for 24 months after completing the 16 week intervention period. Subjects will include 200 women (four groups of 50), 25 to 65 years old with a confirmed diagnosis of FMS. Participants will undergo blinded assessment at the Beth Israel Deaconess Medical Center's GCRC at five time points-baseline, completion of the 16-week intervention and 6, 12 and 24 month follow up. We will assess health and functional status (FIQ, SF36), symptom severity (FIQ, SF36, Beck scales), self-efficacy (Arthritis Self-Efficacy Scale), fitness (muscle strength, cardiovascular fitness, flexibility) and health care utilization (direct and indirect costs). The study will improve treatment outcomes for persons with FMS by identifying the optimal self-management program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Aerobic and flexibility exercise | Experimental | Behavioral: Aerobic16 weeks of aerobic and flexibility exercise. Three days per week for 1 hour of walking and cycling. |
| Strength, aerobic, and flexibility | Experimental | Behavioral: Strength training16 weeks of strength training, aerobic, and flexibility exercise (ST) intervention; |
| Fibromyalgia Self-Help Course | Experimental | Behavioral: FSHC7 weeks of FSHC behavior change education |
| a Combination of ST and FSHC | Experimental | Behavioral: Combination16 wks of a combination of ST and FSHC (ST-FSHC) exercise and behavior change education |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Women aged 25 to 75 years of age
- A confirmed diagnosis of FMS by a primary care physician (and rheumatologist if present) using the American College of Rheumatology criteria
- Currently under care for their FMS by a primary care physician or rheumatologist
- Determined to be medically stable by their primary care physician and capable of participation in a supervised program of low to moderate intensity exercise
- Willingness to commit to time and travel requirements of project
Key exclusion criteria (5 listed)
- Do not fulfill ACR definition of FMS
- Presence of a concurrent condition that limits a person's ability to perform the exercise program (i.e., advanced RA or OA, recent MI)
- History of a positive exercise/stress test, or current cardiovascular, pulmonary, neurological, or renal disease where an exercise program is contraindicated
- Uncontrolled hypertension, diabetes, asthma, or heart failure
- Physician does not want his/her patient to participate for any reason
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 |
|---|---|---|
| Aerobic3x/week of walking and cycling | Behavioural | Aerobic and flexibility exercise |
| Strength training3x/week of resistance training activities | Behavioural | Strength, aerobic, and flexibility |
| Combination3x/week of aerobic and strength training activities | Behavioural | a Combination of ST and FSHC |
| FSHCAlso: Fibromyalgia Self-Help CourseBiweekly group education group meetings | Behavioural | Fibromyalgia Self-Help Course |
Primary outcome
Fibromyalgia Impact Questionnaire
Time frame: Baseline, 16 wks and 10 months
7 secondary outcomes
SF36 subscales
Time frame: Baseline, 16 wks and 10 months
Beck Depression Inventory
Time frame: Baseline, 16 wks and 10 months
Beck Anxiety Inventory
Time frame: Baseline, 16 wks and 10 months
6 minute Walk Test
Time frame: Baseline, 16 wks and 10 months
1 Repetition Maximum Chest Press
Time frame: Baseline, 16 wks and 10 months
1 Repetition Maximum Leg Press
Time frame: Baseline, 16 wks and 10 months
Self Efficacy Scale
Time frame: Baseline, 16 wks and 10 months
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 14 Mar 2017.
- Background: PubMed 11932874Rooks DS, Silverman CB, Kantrowitz FG. The effects of progressive strength training and aerobic exercise on muscle strength and cardiovascular fitness in women with fibromyalgia: a pilot study. Arthritis Rheum. 2002 Feb;47(1):22-8. doi: 10.1002/art1.10180.
- Results publication: PubMed 17998491Rooks DS, Gautam S, Romeling M, Cross ML, Stratigakis D, Evans B, Goldenberg DL, Iversen MD, Katz JN. Group exercise, education, and combination self-management in women with fibromyalgia: a randomized trial. Arch Intern Med. 2007 Nov 12;167(20):2192-200. doi: 10.1001/archinte.167.20.2192.
- Individual participant dataSharing planned: No. No plan was prepared, as no data was to be shared.
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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.
Daniel S. Rooks, PhD principal investigator
Beth Israel Deaconess Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic, Strength training and Combination in people with Fibromyalgia, run by Beth Israel Deaconess Medical Center.
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 5 inclusion and 5 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 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Fibromyalgia Impact Questionnaire (time frame: Baseline, 16 wks and 10 months). 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 NCT00321659, which also lists 2 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 14 Mar 2017.