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Behavioral Intervention

Exercise Program for Fibromyalgia (RAN Trial)

N/A

Waitlist Available

Led By Taylor L Taylor

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

For Veterans living with FM: Age 19 years or older

For Veterans living with FM: Widespread pain index (WPI) 7 and symptom severity scale (SSS) score 5 OR WPI 4-6 and SSS score 9

Must not have

For Veterans living with FM: Body mass index > 40

For Veterans living with FM: Chronic kidney disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to understand how certain personality traits, neuroinflammation, and inflammation are related to pain outcomes in Veterans with fibromyalgia. The study also seeks to create an exercise program tailored

Who is the study for?

This trial is for Veterans with Fibromyalgia, a chronic pain condition. Participants should have experienced symptoms like lower self-esteem, depression, anxiety, and increased pain sensitivity. The study aims to understand how exercise can improve mood and reduce pain by affecting inflammation in the brain.

What is being tested?

The focus of this trial is on Moderate Intensity Continuous Training (MICT) as an intervention for managing Fibromyalgia symptoms in Veterans. It will explore how regular exercise might influence emotional well-being and physical pain through changes in neuroinflammation.

What are the potential side effects?

While specific side effects are not listed for moderate intensity exercise, typical reactions may include muscle soreness or fatigue post-exercise. Uncommonly, individuals might experience exacerbation of their fibromyalgia symptoms if they overexert themselves.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a veteran aged 19 or older with fibromyalgia.

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I am a veteran with widespread pain and severe symptoms of fibromyalgia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am a veteran with fibromyalgia and my BMI is over 40.

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I am a veteran with chronic kidney disease.

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I am a veteran with fibromyalgia and have a severe heart condition.

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I am a veteran with fibromyalgia and have heart disease caused by reduced blood flow.

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I am a veteran with a BMI over 40.

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I am currently taking medication that affects how I feel pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Brain Temperature

C-reactive protein

Choline

+16 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Moderate Intensity Continuous TrainingExperimental Treatment1 Intervention

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, they will also be asked to wear a heart rate monitor to measure mean pulse during their exercise sessions.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Moderate Intensity Continuous Training

2020

N/A

~40

0 / 8Eligibility criteria met