Exercise Intensity for Myasthenia Gravis

(MG-Ex Trial)

Overseen By Clinical Trials Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HealthPartners Institute

Disqualifiers: Non-English, Cognitive impairment, Heart failure, others

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

Compensation: Varies

Number of Visits: 36

Duration: 12 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different levels of exercise can benefit people with myasthenia gravis (MG), a condition that causes muscle weakness. The study compares light intensity exercise (also known as low-intensity or gentle exercise) with moderate intensity exercise (also referred to as aerobic exercise, physical activity, or moderate exercise) to determine which improves health outcomes more effectively. Participants will exercise in small groups three times a week for 12 weeks. This trial suits adults with MG who haven't engaged in regular exercise recently and are on stable medication. As an unphased trial, it offers a unique opportunity to explore personalized exercise benefits for MG patients.

Will I have to stop taking my current medications?

The trial requires that you have been on a stable medication regimen for myasthenia gravis for the last 3 months, so you should not stop taking your current medications.

What prior data suggests that these exercise intensities are safe for individuals with Myasthenia Gravis?

Research has shown that exercise is generally safe for people with myasthenia gravis (MG). Studies indicate that individuals with MG tolerate both light and moderate exercises well. Light exercise can improve muscle strength and lung function. Other research suggests it also enhances overall physical ability and quality of life.

Moderate exercise is safe as well. It benefits those with mild MG symptoms, with very few exercise-related problems reported. Most people can exercise without serious issues. Overall, both types of exercise are considered safe and may offer health benefits for people with MG. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial exploring exercise intensity for Myasthenia Gravis because it delves into how different levels of physical activity might help manage this condition. Unlike traditional treatments that often focus on medications like anticholinesterase drugs or immunosuppressants, this approach examines the role of exercise as a therapeutic option. The trial compares light intensity exercise, which involves lower heart rate and exertion levels, with moderate intensity exercise, which is slightly more demanding. By understanding how exercise affects symptoms, researchers hope to offer a non-drug alternative that can be tailored to individual capabilities and improve quality of life for patients.

What evidence suggests that this trial's exercise programs could be effective for Myasthenia Gravis?

This trial will compare the effects of light intensity exercise and moderate intensity exercise on individuals with myasthenia gravis (MG). Studies have shown that exercise can benefit people with MG, a condition that causes muscle weakness. Participants in the light intensity exercise arm, which includes activities like gentle cycling, may see significant improvements in muscle strength and fitness within just 8 weeks. Meanwhile, those in the moderate intensity exercise arm may experience strengthened breathing muscles, reduced breathlessness, and improved overall physical ability. Research indicates that both light and moderate exercise are generally safe for MG patients, with few side effects reported. Overall, exercise appears promising for improving health outcomes in those with MG. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with Myasthenia Gravis, a condition causing muscle weakness. It's designed to test whether different exercise intensities affect their health outcomes. Participants will join the NeuroWell program and must be able to exercise three times a week for 12 weeks.

Inclusion Criteria

My MG medication has not changed in the last 3 months.

Ability to provide and provision of signed and dated informed consent form

I have been diagnosed with generalized myasthenia gravis.

Exclusion Criteria

I am not pregnant and do not plan to become pregnant during the study.

Any other medical conditions that could affect their ability to participate in exercise for the study duration (as determined by study investigators)

Active participation or past participation ≤3 months in any other interventional research study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are enrolled in the NeuroWell exercise program, participating in a small group exercise program 3 times a week for 12 weeks, randomized into light or moderate intensity exercise groups

12 weeks

36 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the exercise program

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Light Intensity Exercise
• Moderate Intensity Exercise

Trial Overview The study compares light vs. moderate intensity exercises in managing Myasthenia Gravis symptoms. A total of 20 participants will be randomly assigned to one of two groups, exercising under supervision by Certified Exercise Physiologists at the Neuroscience Center.

How Is the Trial Designed?

Group I: Moderate intensity Exercise Experimental Treatment 1 Intervention

Aerobic intensity levels: HRR 40-59%, 12-13 Borg RPE Strength intensity levels: %1RM 60-80%, OMNI RPE 5-6

Group II: Light intensity Exercise Experimental Treatment 1 Intervention

Aerobic intensity levels: Heart rate reserve (HRR) 30-39%, 9-11 Borg Rate of Perceived Exertion (RPE) Strength intensity levels: %One Repetition Max (1RM) 40-50%, OMNI RPE 1-4

Who Is Running the Clinical Trial?

HealthPartners Institute

Lead Sponsor

Trials

196

Recruited

3,721,000+

Published Research Related to This Trial

A 24-week exercise program combining aerobic and resistance training was well tolerated by 34 patients with stable myasthenia gravis (MG), leading to improvements in disease severity and physical fitness without significant changes in body composition.

Patients with lower disease severity (QMG scores) showed greater improvements in physical fitness, while those in the high exercise group experienced some muscle mass loss but improved in walking speed and forced vital capacity, suggesting that exercise is safe and beneficial for enhancing muscular and physical functions in MG patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in Physical Fitness and Body Composition Associated with Physical Exercise in Patients with Myasthenia Gravis: A Longitudinal Prospective Study. Chang, CC., Chen, YK., Chiu, HC., et al.[2021]

A strength training program over ten weeks for 11 patients with mild to moderate myasthenia gravis resulted in a significant 23% increase in maximal voluntary muscle force in knee extension on the trained side, compared to only 4% on the untrained side.

The training was safe, with no adverse effects reported on the patients' myasthenia gravis, indicating that physical training can be beneficial for improving muscle strength in individuals with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical training effects in myasthenia gravis. Lohi, EL., Lindberg, C., Andersen, O.[2006]

A tailored exercise program in a gym setting was safely implemented for seven patients with generalized myasthenia gravis (MG), showing improvements in aerobic capacity, muscle strength, and balance.

This study suggests that well-controlled MG patients can benefit from personalized training in the community, paving the way for broader access to exercise interventions for MG management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of tailored exercise programs for MG patients in a gym setting: a pragmatic feasibility case study. Punga, AR., Westerberg, E., Åsenlöf, P.[2023]

A 12-week supervised exercise program combining aerobic and resistance training led to significant improvements in muscle parameters for 11 patients with Myasthenia gravis, particularly in the rectus femoris muscle, including increased muscle force and thickness.

The study highlights that tailored exercise can enhance muscle function and physical performance in MG patients, suggesting that such programs are safe and beneficial, especially for proximal leg muscles, despite the absence of existing exercise guidelines for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of physical exercise on neuromuscular function in Myasthenia gravis patients: A single-subject design study. Westerberg, E., Molin, CJ., Spörndly Nees, S., et al.[2023]

A review of ten intervention studies involving 159 patients with myasthenia gravis found that systematic physical training is safe and can significantly improve muscle strength, daily function, and quality of life.

Patients with mild to moderate myasthenia gravis are recommended to engage in at least 150 minutes of exercise per week, with the type and intensity of training tailored to individual needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical training and exercise in myasthenia gravis. Gilhus, NE.[2021]

This study is the largest randomized controlled trial to evaluate the effects of a home-based physical exercise program on quality of life and physical fitness in patients with stabilized autoimmune myasthenia gravis, involving 42 participants aged 18-70.

The trial aims to assess not only the perceived quality of life through the MGQOL-15-F questionnaire but also various physical and psychological outcomes, ensuring a comprehensive evaluation of exercise benefits and safety measures over a six-month period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The benefits and tolerance of exercise in myasthenia gravis (MGEX): study protocol for a randomised controlled trial. Birnbaum, S., Hogrel, JY., Porcher, R., et al.[2019]

In a study involving 45 adults with stabilized generalized myasthenia gravis, a 3-month home rowing exercise program was found to be well tolerated, indicating that exercise can be safely integrated into their usual care.

However, the exercise intervention did not lead to a significant improvement in health-related quality of life compared to usual care, suggesting that while exercise is safe, it may not enhance overall well-being in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based exercise in autoimmune myasthenia gravis: A randomized controlled trial. Birnbaum, S., Porcher, R., Portero, P., et al.[2021]

In a study involving 40 patients with mild to moderate myasthenia gravis, a 30-minute exercise routine significantly improved quality of life compared to a rest group, as measured by the MG-QOL15 scale.

The exercise group also showed better performance in the 6-minute walk test, indicating enhanced physical capability, with no reported adverse events, suggesting that regular exercise is a safe and effective intervention for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rest or 30-Min Walk as Exercise Intervention (RESTOREX) in Myasthenia Gravis: A Randomized Controlled Trial. Misra, UK., Kalita, J., Singh, VK., et al.[2022]

In a study of 69 patients with myasthenia gravis, nearly half did not meet international recommendations for moderate to vigorous physical activity, highlighting a significant gap in physical activity levels among this population.

Disease severity and age were identified as key predictors of physical activity intensity, suggesting that these factors should be considered when advising patients on maintaining an active lifestyle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Habitual Physical Activity in Patients with Myasthenia Gravis Assessed by Accelerometry and Questionnaire. Andersen, LK., Vissing, J.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7403401/

Myasthenia Gravis and Physical Exercise: A Novel Paradigm The results showed a significant 23% increase in maximal voluntary muscle force in knee extension compared to 4% on the untrained side. All ...

2. withpower.com withpower.com/trial/phase-muscle-weakness-7-2024-2add7?condition=myasthenia+gravis&overallStatus=Recruiting&hasNoPlacebo=false

Exercise Intensity for Myasthenia Gravis (MG-Ex Trial) A 12-week supervised exercise program combining aerobic and resistance training led to significant improvements in muscle parameters for 11 patients with ...

3. healthpartners.com healthpartners.com/institute/research/studies/light-vs-moderate-intensity-exercise-in-individuals-with-myasthenia-gravis/

Light vs. Moderate Intensity Exercise in Individuals with ... The purpose of this study is to test the difference between light and moderate intensity exercise on health outcomes in people with MG.

4. journals.lww.com journals.lww.com/bhsj/fulltext/2023/06020/effect_of_light_intensity_cycle_ergometer_aerobic.3.aspx

Effect of Light-Intensity Cycle Ergometer Aerobic Exercise... Light intensity cycle ergometer aerobic exercise significantly improved the functional and aerobic capacity in the intervention group at 8 weeks (2MWT distance ...

5. journals.ku.edu journals.ku.edu/rrnmf/article/download/18699/19130/58813

Exercise training for autoimmune myasthenia gravis Effectiveness of exercise​​ Of three studies that used the MG-ADL as an outcome measure, only one showed an improvement following exercise. 26 Seven studies used ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11731934/

Low-intensity aerobic cycle ergometer effects on lung ... In conclusion, eight weeks of low-intensity aerobic cycle ergometer exercise led to significant improvements in FVC and FEV1 among MG patients.

7. mdpi.com mdpi.com/2077-0383/10/17/4031

Changes in Physical Fitness and Body Composition ... These findings indicate that physical exercise is well tolerated by patients with MG, and is accompanied by improved muscular and physical functions.