Fibromyalgia6MWTNCT07611539
The Role of Resilience for Physical Functioning of Patients With Fibromyalgia Syndrome Using the 6-Min Walk Test
An observational study of Fibromyalgia and Physical Function, run by University of Florida.
Trial summary
Fibromyalgia (FM) is a prevalent chronic pain disorder, characterized by widespread musculoskeletal pain and fatigue that is associated with significant functional limitations. Its mechanisms are only partially understood. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Physical Function, Six-minute Walk Test
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2026to 30 Apr 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is a case-control study of FM and healthy controls (HC) that will be enrolled in a ratio of 1:1. Healthy controls will be age/gender matched to the FM group.
Who may be able to join
- Ages 18-70
- Fulfills the 1990 and 2011 American College of Rheumatology Criteria for FM
- Healthy volunteers: No significant pain
Who cannot join
- Uncontrolled diabetes
- Cancer
- Uncontrolled coronary syndromes
- Peripheral neuropathies
- Unwillingness/inability to discontinue analgesics, hypnotics, anxiolytics, or stimulants
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Fibromyalgia (FM) is a prevalent chronic pain disorder, characterized by widespread musculoskeletal pain and fatigue that is associated with significant functional limitations. Its mechanisms are only partially understood. The investigators hypothesize that physical functioning (as measured by the 6-Min Walk Test) of FM patients and healthy controls is negatively influenced by resilience and pain sensitivity. The investigators will perform a case control study to test our hypothesis within and between groups.
- Conditions
- Fibromyalgia, Physical Function, Six-minute Walk Test
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia | Participants who fulfill the 1990 and 2011 American College of Rheumatology Criteria for FM. | |
| Healthy Volunteers | Age/gender matched volunteers who do not have significant pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience score
The Brief Resilience Scale (BRS) is a self-report measure designed to assess an individual's ability to bounce back or recover from stress, adversity, and challenging life circumstances (Smith et al., 2008) scored ranging 6-30.
Measured: Through study completion (one visit - approx. 2 hours)
Performance in 6MWT
The total walking distance in the 6MWT is a measurement of how far an individual is able to walk (measured in meters, using a marked 30m hallway) within a 6 minute time period after being instructed to walk as far possible.
Measured: Through study completion (one visit - approx. 2 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start30 Jul 2026 (estimated)
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland Staud, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07611539
- Sponsor's protocol ID
- IRB202600417
- Acronym
- 6MWT
- Status last verified
- Jul 2026
- First submitted
- 30 Apr 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Resilience for Physical Functioning of Patients With Fibromyalgia Syndrome Using the 6-Min Walk Test
- ClinicalTrials.gov ID
- NCT07611539
- Acronym / sponsor ID
- 6MWT / IRB202600417
- Conditions
- Fibromyalgia, Physical Function, Six-minute Walk Test
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2031 (estimated)
- First posted
- 28 May 2026 (actual)
- 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.
Fibromyalgia (FM) is a prevalent chronic pain disorder, characterized by widespread musculoskeletal pain and fatigue that is associated with significant functional limitations. Its mechanisms are only partially understood. The investigators hypothesize that physical functioning (as measured by the 6-Min Walk Test) of FM patients and healthy controls is negatively influenced by resilience and pain sensitivity. The investigators will perform a case control study to test our hypothesis within and between groups.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia | – | –Participants who fulfill the 1990 and 2011 American College of Rheumatology Criteria for FM. |
| Healthy Volunteers | – | –Age/gender matched volunteers who do not have significant pain. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is a case-control study of FM and healthy controls (HC) that will be enrolled in a ratio of 1:1. Healthy controls will be age/gender matched to the FM group.
Key inclusion criteria (3 listed)
- Ages 18-70
- Fulfills the 1990 and 2011 American College of Rheumatology Criteria for FM
- Healthy volunteers: No significant pain
Key exclusion criteria (5 listed)
- Uncontrolled diabetes
- Cancer
- Uncontrolled coronary syndromes
- Peripheral neuropathies
- Unwillingness/inability to discontinue analgesics, hypnotics, anxiolytics, or stimulants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Resilience score
Time frame: Through study completion (one visit - approx. 2 hours)
The Brief Resilience Scale (BRS) is a self-report measure designed to assess an individual's ability to bounce back or recover from stress, adversity, and challenging life circumstances (Smith et al., 2008) scored ranging 6-30.
Performance in 6MWT
Time frame: Through study completion (one visit - approx. 2 hours)
The total walking distance in the 6MWT is a measurement of how far an individual is able to walk (measured in meters, using a marked 30m hallway) within a 6 minute time period after being instructed to walk as far possible.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Roland Staud, MD principal investigator
University of Florida
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Physical Function, run by University of Florida.
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 3 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: opening soon, as of the sponsor's last update on 6 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melyssa Godfrey, BS (352-265-8901, melyssa.m.g@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience score (time frame: Through study completion (one visit - approx. 2 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2026.