Walking Exercise Programs for Multiple Sclerosis

Overseen By Grace Wells, BS

Age: Any Age

Sex: Any

Trial Phase: Phase 1

Sponsor: Kessler Foundation

Must not be taking: Antipsychotics, Benzodiazepines

Disqualifiers: Assistive device, Falls, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 months

31 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is a randomized controlled trial (RCT) that compares the effects of two different 12-month aerobic walking exercise programs on cognitive processing speed (CPS), brain MRI, and other functional outcomes in 32 adults with multiple sclerosis (MS) who are able to walk without an assistive device but demonstrate slowed CPS. Participants (N=32) will initially undergo screening via telephone, and after satisfying relevant inclusion/exclusion criteria, will provide informed consent, followed by a baseline assessment of CPS remotely via a HIPAA-compliant virtual platform (i.e., Zoom for Healthcare). This assessment will also serve as a screen for ensuring impaired CPS. Following this virtual session, participants will come into Kessler Foundation (KF) and complete a 3-hour baseline assessment (T0) that includes a relatively short battery of neuropsychological tests, a 40-minute MRI scan, tests of walking function, a short questionnaire packet, followed by cardiopulmonary exercise testing on a motor-driven treadmill. Following T0, participants will be randomly assigned into one of the two aerobic walking ET programs that are remotely-delivered and supported by KF research assistants. As the conditions are delivered and supported remotely by KF personnel, the exercise itself takes place in the home/community setting. Both conditions involve behavior coaching via Zoom for Healthcare. The experimental condition involves high-frequency, high-intensity aerobic walking ET that exceeds the published guidelines for physical activity for adults with MS (GEMS+). GEMS + initially involves 10 minutes of moderate intensity aerobic walking exercise for 3 days per week and progresses to upwards of 40 minutes of vigorous intensity aerobic walking exercise for 5 days per week by month 12. The comparison condition involves mild-to-moderate aerobic walking exercise training that approximates published guidelines (GEMS). GEMS initially involves 10 minutes of light intensity aerobic walking exercise for 2 days per week and progresses up to 30 minutes of moderate intensity aerobic walking exercise for 3 days per week. Both conditions further will be monitored based on Fitbit-measured steps per exercise session. Of note, the sample size will be enrolled using 2 overlapping waves (Wave 1 = 14 participants, Wave 2 = 18 participants), 3 months apart. Participants will return to KF at the mid-point (i.e., T6) and end-point (i.e., T12) of the 12-month intervention period to complete the same assessments as T0. The T6 and T12 outcomes will be administered by treatment-blinded research assistants.

Eligibility Criteria

This trial is for adults with Multiple Sclerosis who can walk unaided but have slow cognitive processing. They must be right-handed, speak English, have low physical activity levels, and be able to visit Kessler Foundation three times in a year. Excluded are those with recent steroid use, assistive device dependence for walking, MRI contraindications like metal implants, severe depression or bipolar/schizophrenia history, fall history within six months or on cognition-affecting drugs.

Inclusion Criteria

Definite MS diagnosis

I have been free from cancer relapse for at least 30 days.

Have Internet access on a device larger than a smartphone

Exclusion Criteria

I am on medication that might affect my thinking or memory.

Demonstrate contraindications for 3T MRI (i.e., having metal/shrapnel in the body, non-MRI compatible aneurysm clips)

Have uncontrolled major depressive disorder or history of bipolar disorder or schizophrenia

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Baseline Assessment

Participants complete a 3-hour baseline assessment including neuropsychological tests, MRI scan, walking function tests, and cardiopulmonary exercise testing

1 day

1 visit (in-person)

Treatment

Participants engage in a 12-month aerobic walking exercise program, either high-frequency/high-intensity or mild-to-moderate intensity, supported remotely

12 months

Remote sessions with periodic in-person assessments

Mid-point Assessment

Participants return for a mid-point assessment at 6 months to complete the same assessments as baseline

1 day

1 visit (in-person)

End-point Assessment

Participants return for an end-point assessment at 12 months to complete the same assessments as baseline

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• GEMS
• GEMS Plus

Trial Overview The WEBCAMS study tests two 12-month home-based aerobic walking programs on brain function and other outcomes in MS patients. GEMS Plus involves high-intensity exercise exceeding guidelines while GEMS follows mild-to-moderate intensity guidelines. Progression varies from 10 minutes thrice weekly to up to 40 minutes five times a week. Outcomes are measured through neuropsychological tests and MRIs at baseline, mid-point (6 months), and end-point (12 months).

Participant Groups

Group I: GEMS Plus Experimental Treatment 1 Intervention

Home-based aerobic walking exercise that exceeds published physical activity guidelines for adults with MS

Group II: GEMS Active Control 1 Intervention

Home-based aerobic walking exercise that meets published physical activity guidelines for adults with MS

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+