Health TrialsbyHealthPanel

Light vs. Moderate Intensity Exercise in Individuals With Myasthenia Gravis

ConditionMyasthenia Gravis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHealthPartners Institute

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Light intensity ExerciseExperimental treatment 1 intervention
Group B: Moderate intensity ExerciseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of light and moderate intensity exercise

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

Time frame
12 weeks
2

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

Time frame
12 weeks
3

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.

Time frame
12 weeks

Secondary outcomes

1

Cardiovascular Test - 6-minute walk test

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.

Time frame
12 weeks
2

Cardiovascular and Strength test

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.

Time frame
12 weeks
3

Strength Test - 1-RM Upper Limb

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.

Time frame
12 weeks
4

Strength Test - 1-RM Lower Limb

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.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HealthPartners Institute

Lead sponsor

Source ClinicalTrials.gov
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