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

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how an exercise program, specifically Moderate Intensity Continuous Training, can help Veterans with fibromyalgia manage pain and improve mood. Researchers will compare Veterans in a structured exercise routine to those on a waitlist to understand exercise's effects on pain and emotional well-being. The trial seeks Veterans who have experienced fibromyalgia symptoms for at least three months and have pain in at least four out of five body regions. As an unphased trial, this study offers Veterans a unique opportunity to contribute to understanding the benefits of exercise for managing fibromyalgia.

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.

What prior data suggests that this exercise program is safe for Veterans with fibromyalgia?

Research shows that moderate exercise, such as aerobic activities, is generally safe for people with fibromyalgia. Studies have found that this type of exercise can improve quality of life, assist with physical activities, and reduce pain without major risks. Participants in these studies did not report serious side effects, indicating that the exercise is well-tolerated. Moderate exercise typically includes activities like walking, which most people find easy and safe. This makes it a promising way to manage fibromyalgia symptoms. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this exercise program for fibromyalgia because it offers a non-drug approach to managing the condition, which is primarily treated with medications like pain relievers, antidepressants, and anti-seizure drugs. Unlike these standard treatments, this program uses moderate-intensity continuous training to potentially improve symptoms through structured aerobic exercise. By focusing on activities like treadmill walking, which also includes balance and flexibility exercises, this approach aims to enhance overall physical fitness and reduce pain without the side effects associated with medications. Plus, participants use heart rate monitors to personalize and optimize their workout intensity, potentially leading to better outcomes.

What evidence suggests that this exercise program might be an effective treatment for fibromyalgia?

Research shows that aerobic exercise, such as Moderate Intensity Continuous Training (MICT), which participants in this trial may receive, can benefit people with fibromyalgia. Studies have found that exercise programs improve quality of life, reduce pain, and enhance physical abilities. Adding stretching to a moderate-intensity exercise routine can also improve sleep and lessen fibromyalgia's effects. Other research indicates that exercise decreases depression and boosts overall well-being in people with fibromyalgia. These findings suggest that exercise could be a promising way to manage fibromyalgia symptoms. ^{1 2 6 7 8}

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

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

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

Group II: Waitlist Control Active Control 1 Intervention

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.

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 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]

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]

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]

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]

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 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]

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 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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32585169/

Effectiveness of High-Intensity Interval Training vs ... Results: Fifty-five participants completed the study. There was no significant difference in FIQ between HIIT vs MICT (1.03; 95% CI, -9.67 to 11.75) after ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999320303828

Effectiveness of High-Intensity Interval Training vs ... Thirty-sessions of HIIT or MICT plus strengthening and stretching exercises were beneficial for disability, pain degree, functional capacity, and quality of ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/ejp.4783

Aerobic Exercise Prescription for Pain Reduction in ... Adding stretching to a moderate-intensity aerobic exercise program significantly increased sleep quality, decreased the impact of fibromyalgia ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6481524/

Aerobic exercise training for adults with fibromyalgia - PMC Moderate‐quality evidence revealed that aerobic exercise improved HRQL, and low‐quality evidence showed improvement in physical function and decreased pain, ...

5. nature.com nature.com/articles/s41598-022-14213-x

Effect of different types of exercise in adult subjects with ... We conclude that exercise may be a way to reduce depression, and pain and improve the quality of life in adult subjects with fibromyalgia.

6. archives-pmr.org archives-pmr.org/article/S0003-9993(20)30382-8/abstract

Effectiveness of High-Intensity Interval Training vs ... The primary outcome measure was the Fibromyalgia Impact Questionnaire (FIQ). The secondary outcome measures were visual analog scale for pain, ...

7. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2024.1413038/full

Adherence to ACSM exercise guidelines and its influence ... Effectiveness of high-intensity interval training vs moderate-intensity continuous training in patients with fibromyalgia: a pilot randomized ...

8. bmj.com bmj.com/content/360/bmj.k851

Effect of tai chi versus aerobic exercise for fibromyalgia Tai chi mind-body treatment results in similar or greater improvement in symptoms than aerobic exercise, the current most commonly prescribed non-drug ...