Light vs. Moderate Intensity Exercise in Individuals With Myasthenia Gravis

NCT06491238 | Recruiting

• 1 other identifier: A24-169
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myasthenia Gravis

Outcome Measures

Primary Outcomes (3)

• Feasibility of light and moderate intensity exercise

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

  12 weeks

• Acceptability of light and moderate intensity exercise

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

  12 weeks

• Tolerability of light and moderate intensity exercise

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

  12 weeks

Secondary Outcomes (4)

• Cardiovascular Test - 6-minute walk test

  12 weeks

• Cardiovascular and Strength test

  12 weeks

• Strength Test - 1-RM Upper Limb

  12 weeks

• Strength Test - 1-RM Lower Limb

  12 weeks

Study Arms (2)

Light intensity Exercise

EXPERIMENTAL

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

Behavioral: Light Intensity Exercise

Moderate intensity Exercise

EXPERIMENTAL

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

Behavioral: Moderate Intensity Exercise

Interventions

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.

Light intensity Exercise

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.

Moderate intensity Exercise

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

HealthPartners Neuroscience Center

Saint Paul, Minnesota, 55130, United States

RECRUITING

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Clinical Trials Coordinator

CONTACT

651-495-6363; ClinicalTrials@HealthPartners.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 9, 2024
• Study Start: September 16, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (1)