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Aerobic Exercise for Multiple Sclerosis

Phase 1 & 2

Waitlist Available

Led By Lindsey B Wooliscroft, MD

Research Sponsored by Oregon Health and Science University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 18-64 years

Be between 18 and 65 years old

Must not have

Clinically confirmed MS relapse in the last 3 months

Medical or biophysical conditions that prohibit the use of a cycle ergometer or treadmill (medical readiness to be assessed by the Activity Readiness Questionnaire (PAR-Q)) or achievement of target heart rate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to week 24

Awards & highlights

No Placebo-Only Group

Summary

This trial is to see if exercising can help people with MS by promoting remyelination.

Who is the study for?

This trial is for adults aged 18-64 with a confirmed diagnosis of multiple sclerosis (MS) who have internet access and can do virtual visits. They must not be very active, pregnant, or have had recent MS treatments or relapses. Changes in their MS medication within the last 6 months or certain medications affecting tests are also disqualifiers.

What is being tested?

The study is testing if aerobic exercise like stationary cycling can help repair nerve insulation damage caused by MS. Participants will either join an education group as a control or engage in the exercise program to see if it makes a difference.

What are the potential side effects?

While specific side effects aren't listed for this trial, general risks may include muscle soreness, fatigue, and potential exacerbation of some MS symptoms due to physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 64 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a multiple sclerosis flare-up in the last 3 months.

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I cannot use a bike or treadmill for health reasons.

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I have a severe narrowing of my spinal canal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to week 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to week 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

7-site skinfold test

Average heart rate (HR) zone during exercise sessions

Brain Myelin Water Fraction (MWF)

+3 more

Other study objectives

6-Minute Timed Walk (6MTW)

9 Hole Peg Test

Activity Readiness Questionnaire (PAR-Q)

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: MS: CycleExperimental Treatment1 Intervention

Twenty-two participants in the clinical trial arm will be randomized to MS:Cycle: an aerobic exercise intervention on a stationary ergometer. Participants will exercise thrice weekly for 30 minutes with graded supervision for 24 weeks.

Group II: MS: Take ControlActive Control1 Intervention

Twenty-two participants in the clinical trial arm will be randomized to MS: Take Control (MSTC): a monthly, hour-long MS education control group led by a trained facilitator.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Aerobic exercise

2000

Completed Phase 2

~1130

0 / 4Eligibility criteria met