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

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

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.

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

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.

Clinical Trials on Fibromyalgia

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