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

Trial Summary

What is the purpose of this trial?

The overall purpose of this pilot study is to examine the feasibility, acceptability, and tolerability of light and moderate intensity exercise in adults with MGeffect of light vs. moderate intensity exercise on health outcomes. Participants will be enrolled into the NeuroWell exercise program, which is geared toward individuals with neurological disorders or injuries and led by Certified Exercise Physiologists (CEPs) at the HealthPartners Neuroscience Center. A total of 20 people with MG will be enrolled in this study and participate in a small group exercise program 3 times a week for 12 weeks. Participants will be randomized into two exercise groups: 1) Light intensity or 2) Moderate intensity. We hypothesize that light and moderate intensity exercise will be feasible, acceptable, and tolerable in adults with MG and that individuals in the light intensity exercise group will be able to achieve the same improvement in health outcomes as the moderate intensity group.

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 data supports the effectiveness of the treatment Light Intensity Exercise, Low-Intensity Exercise, Gentle Exercise, Moderate Intensity Exercise, Aerobic Exercise, Physical Activity, Moderate Exercise for Myasthenia Gravis?

Research shows that physical exercise, including aerobic and resistance training, is safe and can improve muscle strength, walking speed, and overall physical function in patients with myasthenia gravis. Exercise was well tolerated and led to improvements in muscle parameters and daily function, suggesting it can be a beneficial addition to treatment for this condition. ^{1 2 3 4 5}

Is exercise safe for people with myasthenia gravis?

Exercise is generally safe for people with myasthenia gravis, especially when the condition is well-controlled. Studies show that physical activity can improve muscle strength and daily function without significant risks, as long as the exercise is tailored to the individual's condition and capabilities. ^{3 4 6 7 8}

How does light or moderate intensity exercise differ from other treatments for myasthenia gravis?

Light or moderate intensity exercise is unique for myasthenia gravis because it focuses on improving muscle strength and daily function without worsening the condition, unlike some treatments that may not address physical fitness. This exercise regimen is tailored to individual needs and can be safely implemented, enhancing quality of life and physical capabilities for patients with well-controlled symptoms. ^{1 3 4 7 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

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]

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]

References

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

The impact of physical exercise on neuromuscular function in Myasthenia gravis patients: A single-subject design study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

The benefits and tolerance of exercise in myasthenia gravis (MGEX): study protocol for a randomised controlled trial. [2019]

3. Switzerland 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. [2021]

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

Physical training and exercise in myasthenia gravis. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Home-based exercise in autoimmune myasthenia gravis: A randomized controlled trial. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Rest or 30-Min Walk as Exercise Intervention (RESTOREX) in Myasthenia Gravis: A Randomized Controlled Trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Implementation of tailored exercise programs for MG patients in a gym setting: a pragmatic feasibility case study. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Habitual Physical Activity in Patients with Myasthenia Gravis Assessed by Accelerometry and Questionnaire. [2022]

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

Physical training effects in myasthenia gravis. [2006]