Relationships of Affect and Neuroinflammation With Clinical Pain in Veterans With Fibromyalgia

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
VA Office of Research and Development
Study ID
NCT06574165
Status
Recruiting
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Conditions

  • Fibromyalgia

Eligibility Criteria

Sex
ALL
Age
19 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Moderate Intensity Continuous Training — BEHAVIORAL
    6-week structured exercise intervention. The intervention will include twice weekly, center-based, aerobic exercise consisting of continuous treadmill walking. Each center-based session will include 45 minutes of aerobic exercise in addition to balance and flexibility exercises to promote cool-down. During each exercise session, participants will also be asked to wear a heart rate monitor to measure mean pulse during exercise sessions.

Study Details

Fibromyalgia (FM) is a chronic pain condition that disproportionately impacts Veterans. Individuals diagnosed with FM patients experience lower self-esteem and positive affect, as well as greater levels of depression, anxiety, negative affect, and pain catastrophizing. Among those experiencing FM, clinical and experimental pain are associated with specific dispositional trait profiles, which are indexed by levels of negative affect and positive affect. Neuroinflammation and inflammation also play a role in FM- related affect and pain. Recent studies that have highlighted neuroinflammation and inflammation as physiological mechanisms associated with changes in dysregulated affect and chronic pain. Veterans with FM can ameliorate dispositional traits-i.e., increasing positive affect and reducing negative affect-by participating in exercise. However, a gap exists regarding how to optimally engage Veterans with FM in an exercise program. Thus, to fully take advantage of all potential therapeutic benefits of exercise for FM, there is a critical need to identify those factors underlying exercise engagement for FM pain management. The purpose for this study is to 1) determine associations of dispositional trait styles, neuroinflammation, and inflammation with pain outcomes in Veterans with FM; and 2) develop and design a Veteran-informed exercise program.

Key Dates

Start date
Nov 1, 2024
Status verified
Oct 2025
Primary completion
Oct 1, 2026
Completion
Oct 30, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Moderate Intensity Continuous Training
    20 Veterans living with fibromyalgia and 20 Veterans living without fibromyalgia will undergo a 6-week structured exercise intervention. The intervention will include twice weekly, center-based, aerobic exercise consisting of continuous treadmill walking. Each center-based session will include 45 minutes of aerobic exercise in addition to balance and flexibility exercises to promote cool-down. During each exercise session, participants will also be asked to wear a heart rate monitor to measure mean pulse during exercise sessions.
  • No Intervention: Waitlist Control
    10 Veterans living with fibromyalgia and 10 Veterans living without fibromyalgia will undergo a 6-week waitlist control. This will include phone call check-ins on the participant's pain symptoms twice weekly. At completion of the final study visit the participants will be offered the option to participate in the exercise intervention.

Primary Outcome Measure

Dispositional Trait Styles [ Time Frame: Baseline to 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Birmingham VA Medical Center, Birmingham, ALBirminghamAlabama35233-1927
Taylor L Taylor
[email protected]
205-996-7937
Alayne D Markland, DO MSc
[email protected]
(205) 933-8101
Taylor L Taylor (PRINCIPAL_INVESTIGATOR)

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By research site
Birmingham VA Medical Center, Birmingham, AL· Birmingham, AL

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