Exercise Intensity for Myasthenia Gravis
(MG-Ex Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: HealthPartners Institute
Disqualifiers: Non-English, Cognitive impairment, Heart failure, others
No Placebo Group
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.
12345Is 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.
34678How 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.
13479Eligibility 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 am between 18 and 80 years old.
+1 more
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
+6 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Moderate intensity ExerciseExperimental Treatment1 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 ExerciseExperimental Treatment1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
HealthPartners Neuroscience CenterSaint Paul, MN
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Who Is Running the Clinical Trial?
HealthPartners InstituteLead Sponsor
References
The impact of physical exercise on neuromuscular function in Myasthenia gravis patients: A single-subject design study. [2023]There is a need for tailored exercise recommendations to patients with Myasthenia gravis (MG). A few pilot studies have recently shown that physical exercise in accordance with general recommendations to healthy adults can be applied safely to patients with mild MG symptoms. How physical exercise affects muscle parameters and risk factors for lifestyle diseases in patients with MG is, however, only poorly known. We evaluated functional skeletal muscle parameters in 11 MG patients, before and after conducting a 12-week supervised physical therapy regimen of aerobic and resistance strength training. After the training program, parameters of the rectus femoris muscle improved: compound motor action potential (from 4.5 ± 2.6 to 5.3 ± 2.8 mV, P = .016), isometric muscle force (from 25.2 ± 4.4 to 30.2 ± 3.8 kg; P = .014), and ultrasound muscle thickness (from 19.6 ± 5.6 to 23.0 ± 3.9 mm, P = .0098) all increased. Further, physical performance based measures improved, including the 30-Second Chair Stand Test (median change +2, P = .0039) as well as the clinical MG composite score [from 3 (2-5) to 2 (0-4), P = .043]. No improvement in muscle function was observed in the biceps brachii muscle. These findings indicate that MG patients can improve their muscular functions by incorporating aerobic and resistance strength training, especially in proximal leg muscles. This is important knowledge when physical therapy is considered for this patient group, for whom no guidelines on physical exercise currently exist.
The benefits and tolerance of exercise in myasthenia gravis (MGEX): study protocol for a randomised controlled trial. [2019]Research exploring the effects of physical exercise in auto-immune myasthenia gravis (MG) is scarce. The few existing studies present methodological shortcomings limiting the conclusions and generalisability of results. It is hypothesised that exercise could have positive physical, psychological as well as immunomodulatory effects and may be a beneficial addition to current pharmacological management of this chronic disease. The aim of this study is to evaluate the benefits on perceived quality of life (QOL) and physical fitness of a home-based physical exercise program compared to usual care, for patients with stabilised, generalised auto-immune MG.
Changes in Physical Fitness and Body Composition Associated with Physical Exercise in Patients with Myasthenia Gravis: A Longitudinal Prospective Study. [2021]There is a lack of guidelines for physical exercise in patients with myasthenia gravis (MG). A few pilot studies have shown that exercise can be safely applied to patients with MG. However, how physical exercise affects body composition, disease function, and disease severity remains unknown. In this prospective study, we enrolled 34 patients with MG with stable condition and evaluated the disease severity, physical fitness parameters, and body composition (measured using whole-body dual-energy X-ray absorptiometry (DXA)), before and after conducting a 24-week physical exercise regimen of aerobic and resistance strength training. The outcomes were measured by DXA, quantitative MG (QMG) score, quality of life score, handgrip strength and walking speed. During the training regimen, participants were free to decide how many exercise sessions per week and regularly reported their weekly exercise time. The physical exercise program was well tolerated by the participants, the parameters of the QMG score and handgrip strength improved, and participants' body composition did not change significantly. The high exercise group experienced greater deterioration in muscle mass in the arms, but exhibited a greater improvement in forced vital capacity, walking speed, and symptom severity. The group with low QMG scores improved more in terms of physical fitness, including walking speed. These findings indicate that physical exercise is well tolerated by patients with MG, and is accompanied by improved muscular and physical functions. We propose that physical exercise is safe, effective, and appropriate for patients with well-regulated MG.
Physical training and exercise in myasthenia gravis. [2021]Myasthenia gravis is characterized by muscle weakness and fatigue. As sustained muscle use increases the weakness, the value of physical training programs has previously been questioned. This is a review to clarify the safety and usefulness of systematic training in myasthenia gravis, based on a systematic search in available databases using the relevant key words. Ten intervention studies including 159 patients with generalized disease have been published regarding the effect of systematic physical training, three of them on respiratory muscles. Muscle strength improved, and in the majority of the studies also daily function and quality of life. The feeling of fatigue not directly related to actual muscle weakness was less influenced by physical training. Continuous training was necessary to maintain the improved function. Physical training and exercise are safe in myasthenia gravis. This can improve both muscle strength and daily function. Type and intensity of systematic training should be adapted in the individual patient. A minimum of 150 min of exercise per week is recommended for myasthenia gravis patients with mild and moderate disease.
Home-based exercise in autoimmune myasthenia gravis: A randomized controlled trial. [2021]The tolerance of exercise and its effects on quality of life in myasthenia gravis are not currently backed up by strong evidence. The aim of this study was to determine whether exercise as an adjunct therapy is well tolerated and can improve health-related quality of life (HRQoL) in stabilized, generalized autoimmune myasthenia gravis (gMG). We conducted a parallel-group, multi-center prospective RCT using computer-generated block randomization. Adults with stabilized, gMG, and no contra-indication to exercise, were eligible. Participants received usual care alone or usual care and exercise. The exercise intervention consisted of 3-weekly 40 min sessions of an unsupervised, moderate-intensity home rowing program over 3 months. The primary endpoint was the change in HRQoL from randomization to post-intervention. Assessor-blinded secondary endpoints were exercise tolerance and effects on clinical, psychological and immunological status. Of 138 patients screened between October 2014 and July 2017, 45 were randomly assigned to exercise (n = 23) or usual care (n = 20). Although exercise was well tolerated, the intention-to-treat analysis revealed no evidence of improved HRQoL compared to usual care (MGQOL-15-F; mean adjusted between-groups difference of -0.8 points, 95%CI -5.4 to 3.7). Two patients hospitalized for MG exacerbation were from the usual care group.
Rest or 30-Min Walk as Exercise Intervention (RESTOREX) in Myasthenia Gravis: A Randomized Controlled Trial. [2022]There is a lack of evidence about the usefulness of exercise or rest in myasthenia gravis (MG). This study is aimed to evaluate the efficacy and safety of exercise or rest in MG.
Implementation of tailored exercise programs for MG patients in a gym setting: a pragmatic feasibility case study. [2023]Although supervised aerobic and resistance training in a hospital setting was proven safe and beneficial for well-controlled myasthenia gravis (MG) patients, implementation of similar programs in the community has not been studied. We conducted a pragmatic open-label study at a large gym in Uppsala, Sweden. Seven patients with generalized MG were recruited to participate in an individualized, tailored exercise program, based on individual baseline status and personal goals, with a personal trainer. All patients completed the entire training period. The individually tailored exercise program was implemented safely and effectively, with all patients improving in aerobic capacity, muscle strength, and balance. Our pragmatic open-label case study suggests that well-controlled patients with generalized MG can extend their physical exercise to personal training in the gym. This is an essential step towards reducing the barriers to implementing exercise procols and increasing the availability of these interventions to MG patients.
Habitual Physical Activity in Patients with Myasthenia Gravis Assessed by Accelerometry and Questionnaire. [2022]Physical activity (PA) in patients with myasthenia gravis (MG) is considered safe and beneficial, and an active lifestyle is required to obtain the health benefits of exercise. However, as the disease leads to physical impairments an insight into the overall PA habits in this patient population is relevant but lacking.
Physical training effects in myasthenia gravis. [2006]Eleven patients with mild or moderate myasthenia gravis (MG) were subjected to a strength training program of 27 to 30 sessions during ten weeks. Voluntary maximal muscle force and the degree of fatigue during repetitive maximal isometric muscle contractions were measured in three muscle groups. The subjects did not experience any subjective discomfort or any adverse effect on their MG due to the training. A 23% increase of the maximal voluntary muscle force in knee extension in the trained side was found, compared to 4% in the untrained side (p