Exercise Program for Fibromyalgia

(RAN Trial)

Overseen By Alayne D Markland, DO MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Opioids, Beta-blockers

Disqualifiers: Neurological disorder, BMI > 40, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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 their 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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are a Veteran without fibromyalgia, you cannot actively use medications that affect pain responses.

Is exercise safe for people with fibromyalgia?

Exercise, including aerobic and strength training, is generally safe for people with fibromyalgia. Studies show that exercise can improve fitness and reduce symptoms when done at an appropriate intensity and tailored to individual needs. ^{1 2 3 4 5}

How does the Moderate Intensity Continuous Training treatment differ from other treatments for fibromyalgia?

Moderate Intensity Continuous Training is unique because it focuses on continuous aerobic exercise, which has been shown to improve muscle performance, reduce pain, and enhance quality of life in fibromyalgia patients. Unlike some other treatments, it does not rely on medication and instead uses physical activity to manage symptoms. ^{5 6 7 8 9}

What data supports the effectiveness of the treatment Moderate Intensity Continuous Training, Moderate Intensity Exercise, Continuous Aerobic Exercise for fibromyalgia?

Research shows that aerobic exercise, which is part of the treatment, can improve fitness and reduce symptoms in people with fibromyalgia. Studies have found that exercise programs, especially those of appropriate intensity, can lead to better health and symptom relief. ^{1 4 10 11 12}

Who Is on the Research Team?

Taylor L Taylor

Principal Investigator

Birmingham VA Medical Center, Birmingham, AL

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I experience widespread pain in at least four out of five body regions.

I am a veteran diagnosed with fibromyalgia, regardless of other conditions.

Exclusion Criteria

For Veterans living with FM: 90 days of daily opioid use

For Veterans living with FM: Inability to consent for study participation (significant cognitive impairment, known diagnosis of dementia, MRI contraindications, pregnancy)

I am a veteran without fibromyalgia but have a neurological disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a 6-week moderate intensity continuous training exercise intervention, including twice weekly, center-based aerobic exercise sessions.

6 weeks

12 visits (in-person)

Follow-up

Participants undergo follow-up MRSI scans, pain assessments, and semi-structured interviews to monitor changes in neuroinflammation and pain outcomes.

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Moderate Intensity Continuous Training

Trial Overview 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.

How Is the Trial Designed?

Group I: Moderate Intensity Continuous Training Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A 24-week randomized controlled trial with 64 women diagnosed with fibromyalgia showed that both supervised aerobic exercise (AE) and a combined exercise program (CE) led to significant improvements in fibromyalgia symptoms, with a 14% to 15% reduction in the Fibromyalgia Impact Questionnaire scores.

The combined exercise program (CE) was more effective than aerobic exercise alone in enhancing physical functioning, vitality, and mental health, while also improving shoulder/hip range of motion and handgrip strength, suggesting that a mix of exercises offers greater overall health benefits for women with fibromyalgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic exercise versus combined exercise therapy in women with fibromyalgia syndrome: a randomized controlled trial. Sañudo, B., Galiano, D., Carrasco, L., et al.[2022]

In a study of 76 women with fibromyalgia, aerobic exercise was found to be more effective than stretching in improving various health outcomes, including cardiorespiratory fitness, function, depression, and pain levels over a 20-week period.

Despite the benefits of aerobic exercise, improvements in cardiorespiratory fitness were not directly linked to reductions in fibromyalgia symptoms, suggesting that other factors may contribute to symptom relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aerobic fitness effects in fibromyalgia. Valim, V., Oliveira, L., Suda, A., et al.[2011]

A review of 46 exercise treatment studies involving 3035 fibromyalgia patients found strong evidence supporting aerobic exercise as an effective treatment for improving fitness and reducing symptoms.

Lower intensity exercise programs were associated with the greatest benefits and lowest dropout rates, highlighting the importance of tailoring exercise intensity to individual capabilities for optimal outcomes in fibromyalgia treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive review of 46 exercise treatment studies in fibromyalgia (1988-2005). Jones, KD., Adams, D., Winters-Stone, K., et al.[2023]

Aerobic exercise (AE) was found to be the most effective treatment for fibromyalgia among 60 patients over a 14-week period, showing positive short-term effects despite initial skepticism from participants.

At the 4-year follow-up, there were no significant differences in symptom severity among the treatment groups, indicating that long-term compliance with AE may be a challenge affecting its sustained benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of aerobic exercise versus stress management treatment in fibromyalgia. A 4.5 year prospective study. Wigers, SH., Stiles, TC., Vogel, PA.[2022]

A meta-analysis of randomized controlled trials involving 377 participants showed that exercise significantly improves global well-being in adults with fibromyalgia, with a standardized effect size indicating meaningful benefits.

Both aerobic and strength training exercises were effective, and the results were consistent across different analytical methods, confirming the positive impact of exercise on well-being in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise improves global well-being in adults with fibromyalgia: confirmation of previous meta-analytic results using a recently developed and novel varying coefficient model. Kelley, GA., Kelley, KS.[2017]

A 20-week exercise program combining strength training and cardiovascular exercise was safe and well-tolerated by 15 women with fibromyalgia syndrome, with no reported injuries and an 81% compliance rate.

Participants showed significant improvements in muscle strength, cardiovascular endurance, and overall functional status, indicating that this exercise program can effectively enhance quality of life for women with fibromyalgia without worsening their symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of progressive strength training and aerobic exercise on muscle strength and cardiovascular fitness in women with fibromyalgia: a pilot study. Rooks, DS., Silverman, CB., Kantrowitz, FG.[2019]

Female patients with fibromyalgia syndrome (FMS) showed normal cardiorespiratory fitness levels compared to healthy controls, indicating that their physical fitness may not be as impaired as previously thought.

However, FMS patients reported significantly higher levels of perceived exertion during exercise, suggesting that their experience of pain may influence how hard they feel they are working, which is important to consider when designing exercise programs for them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fitness and perceived exertion in patients with fibromyalgia syndrome. Nielens, H., Boisset, V., Masquelier, E.[2022]

Circuit training (T(CIRC)) was found to be more effective than aerobic training (TA) in improving the quality of life for women with fibromyalgia, as measured by diagnostic tests.

While circuit training showed greater improvements in strength, aerobic training yielded better results in aerobic capacity over a 6-week period, suggesting both methods have unique benefits for managing fibromyalgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of two different training methods in women with fibromyalgia syndrome. de Araújo Farias, D., Abrahão, AA., Rossato, M., et al.[2013]

A 6-week exercise program that included aerobic, flexibility, and strengthening exercises significantly improved tender points, total myalgic scores, and aerobic fitness in fibromyalgia patients compared to a relaxation group, indicating its efficacy in managing the condition.

The study involved 60 patients with fibromyalgia, and those who participated in the exercise program experienced no adverse effects, suggesting that such programs are safe for individuals with this chronic condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exercise program in the treatment of fibromyalgia. Martin, L., Nutting, A., MacIntosh, BR., et al.[2022]

A 3-month muscular aerobic revalidation program significantly improved muscle performance in patients with fibromyalgia.

Participants experienced reduced pain levels and enhanced quality of life, confirming the effectiveness of aerobic exercise in managing fibromyalgia symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Value of aerobic rehabilitation in the management of fibromyalgia]. Maquet, D., Croisier, JL., Demoulin, C., et al.[2015]

A 3-week intensive residential treatment program for 25 women with fibromyalgia led to significant long-term reductions in pain intensity and area, with improvements lasting up to 12 months.

The program also enhanced aerobic fitness, as indicated by increased deep pressure pain thresholds and aerobic capacity, suggesting that incorporating physical exercise as a coping strategy may contribute to sustained symptom relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year efficacy of a 3-week intensive multidisciplinary non-pharmacological treatment program for fibromyalgia patients. Suman, AL., Biagi, B., Biasi, G., et al.[2018]

This study will compare the effects of progressive versus constant intensity resistance training on various aspects of fibromyalgia, including pain, sleep quality, and anxiety, over 24 sessions with participants randomized into three groups.

The progressive intensity group will increase their training load every month based on individual strength assessments, potentially leading to greater benefits in managing fibromyalgia symptoms compared to the constant intensity and walking control groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of progressive intensity resistance training on the impact of fibromyalgia: protocol for a blinded randomized controlled trial. Pontes-Silva, A., Dibai-Filho, AV., de Melo, TS., et al.[2023]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Aerobic exercise versus combined exercise therapy in women with fibromyalgia syndrome: a randomized controlled trial. [2022]

2. Canada pubmed.ncbi.nlm.nih.gov

Aerobic fitness effects in fibromyalgia. [2011]

3. England pubmed.ncbi.nlm.nih.gov

A comprehensive review of 46 exercise treatment studies in fibromyalgia (1988-2005). [2023]

4. England pubmed.ncbi.nlm.nih.gov

Effects of aerobic exercise versus stress management treatment in fibromyalgia. A 4.5 year prospective study. [2022]

5. Italy pubmed.ncbi.nlm.nih.gov

Exercise improves global well-being in adults with fibromyalgia: confirmation of previous meta-analytic results using a recently developed and novel varying coefficient model. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

The effects of progressive strength training and aerobic exercise on muscle strength and cardiovascular fitness in women with fibromyalgia: a pilot study. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Fitness and perceived exertion in patients with fibromyalgia syndrome. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Effects of two different training methods in women with fibromyalgia syndrome. [2013]

9. Canada pubmed.ncbi.nlm.nih.gov

An exercise program in the treatment of fibromyalgia. [2022]

10. Belgium pubmed.ncbi.nlm.nih.gov

[Value of aerobic rehabilitation in the management of fibromyalgia]. [2015]

11. Italy pubmed.ncbi.nlm.nih.gov

One-year efficacy of a 3-week intensive multidisciplinary non-pharmacological treatment program for fibromyalgia patients. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Effects of progressive intensity resistance training on the impact of fibromyalgia: protocol for a blinded randomized controlled trial. [2023]