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NCT Number: NCT06491238

Light vs. Moderate Intensity Exercise in Individuals With Myasthenia Gravis

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.

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Key information

Conditions

Myasthenia Gravis Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

Location status: Recruiting

Location contact

Clinical Trial Coordinator

CONTACT

[email protected]

651-495-6363

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to provide and provision of signed and dated informed consent form.
  • Age 18-80
  • Diagnosis of generalized MG.
  • On a stable MG prescription medication regimen for the last 3 months.

Exclusion criteria

  • Non-English speaking
  • Regular exercise participation within the month prior to study enrollment or any outside exercise participation during the study intervention period.
  • Significant cognitive impairment of any etiology that would impact study participation.
  • History of heart failure, chronic lung disease, angina or any other condition that causes unreasonable shortness of breath on exertion.
  • History of any serious neurological, psychiatric, or substance use disorders that would impact study participation.
  • Women who are currently pregnant or planning 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.
  • Unwilling to participate in all study related activities.

Treatment and study plan

Light Intensity Exercise

Behavioral

12 weeks light intensity strength and endurance NeuroWell exercise program, specifically developed for individuals with neurological disorders or injuries. Participants have the intensity goals descripted in the experimental arm.

Moderate Intensity Exercise

Behavioral

12 weeks moderate intensity strength and endurance NeuroWell exercise program, specifically developed for individuals with neurological disorders or injuries. Participants have the intensity goals descripted in the experimental arm.

Primary outcomes

  1. Feasibility of light and moderate intensity exercise

    Time frame: 12 weeks

    Percent of participants recruited of potential participants contacted. Range: [0-100]. Higher percentage indicates higher feasibility

  2. Acceptability of light and moderate intensity exercise

    Time frame: 12 weeks

    Percent of participants who complete the program of participants who start the program. Range: [0-100]. Higher percentage indicates higher acceptability

  3. Tolerability of light and moderate intensity exercise

    Time frame: 12 weeks

    Percent of classes participants complete during the course of the program. Range: [0-100]. Higher percentage indicates higher tolerability.

Secondary outcomes

  1. Cardiovascular Test - 6-minute walk test

    Time frame: 12 weeks

    Pre-post change in distance a person can walk during the 6-minute walk test. Change = Post distance - pre distance. Larger positive difference in distance indicates a larger improvement in cardiovascular health from pre-post program.

  2. Cardiovascular and Strength test

    Time frame: 12 weeks

    Pre-post change in time it takes a person to transfer from seated to standing position and then back to seated position 5 times. Change = Post time- pre time. Larger positive difference in time indicates a larger improvement in cardiovascular health and strength from pre-post program.

  3. Strength Test - 1-RM Upper Limb

    Time frame: 12 weeks

    Pre-post change in weight that can be lifted during the 1-RM test. Change = Post 1-RM upper limb weight -pre 1-RM upper limb weight. Larger positive difference in weight lifted indicates a larger improvement in upper limb strength from pre-post program.

  4. Strength Test - 1-RM Lower Limb

    Time frame: 12 weeks

    Pre-post change in weight that can be lifted during the 1-RM test. Change = Post 1-RM lower limb weight -pre 1-RM lower limb weight. Larger positive difference in weight lifted indicates a larger improvement in lower limb strength from pre-post program.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Coordinator

CONTACT

[email protected]

651-495-6363

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Registry information

Acronym: MG-Ex

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 9, 2024
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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