- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07611539
The Role of Resilience for Physical Functioning of Patients With Fibromyalgia Syndrome Using the 6-Min Walk Test (6MWT)
May 22, 2026 updated by: University of Florida
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 Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Melyssa Godfrey, BS
- Phone Number: 352-265-8901
- Email: melyssa.m.g@ufl.edu
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Ages 18-70
- Fulfills the 1990 and 2011 American College of Rheumatology Criteria for FM
- Healthy volunteers: No significant pain
Exclusion Criteria:
- Uncontrolled diabetes
- Cancer
- Uncontrolled coronary syndromes
- Peripheral neuropathies
- Unwillingness/inability to discontinue analgesics, hypnotics, anxiolytics, or stimulants
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
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Through study completion (one visit - approx. 2 hours)
|
|
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.
|
Through study completion (one visit - approx. 2 hours)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Roland Staud, MD, University of Florida
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 (Estimated)
April 30, 2026
Primary Completion (Estimated)
April 30, 2030
Study Completion (Estimated)
April 30, 2031
Study Registration Dates
First Submitted
April 30, 2026
First Submitted That Met QC Criteria
May 22, 2026
First Posted (Actual)
May 28, 2026
Study Record Updates
Last Update Posted (Actual)
May 28, 2026
Last Update Submitted That Met QC Criteria
May 22, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB202600417
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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