The Role of Resilience for Physical Functioning of Patients With Fibromyalgia Syndrome Using the 6-Min Walk Test

NCT07611539 | Not Yet Recruiting

• 1 other identifier: IRB202600417
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Through study completion (one visit - approx. 2 hours)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Ages 18-70
• Fulfills the 1990 and 2011 American College of Rheumatology Criteria for FM
• Healthy volunteers: No significant pain

You may not qualify if:

• Uncontrolled diabetes
• Cancer
• Uncontrolled coronary syndromes
• Peripheral neuropathies
• Unwillingness/inability to discontinue analgesics, hypnotics, anxiolytics, or stimulants

Sponsors & Collaborators

• University of Florida: lead

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Roland Staud, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melyssa Godfrey, BS

CONTACT

352-265-8901; melyssa.m.g@ufl.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 28, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2031
• Last Updated: May 28, 2026

Record last verified: 2026-03