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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two home-based walking exercise programs, GEMS and GEMS Plus, can improve brain processing speed and overall function in people with multiple sclerosis (MS). One group will engage in a high-intensity walking program, while the other will follow a more moderate routine. It suits those with MS who can walk unaided and experience slower thinking speeds in daily activities. Participants must visit the Kessler Foundation three times a year and be willing to exercise regularly. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to explore these innovative exercise programs.

Will I have to stop taking my current medications?

The trial requires that you do not regularly take medications that can affect cognition, such as antipsychotics or benzodiazepines. If you are taking these, you may need to stop or switch medications to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that exercise programs for people with multiple sclerosis (MS) are generally safe and well-tolerated. One study found that home-based exercise programs can be safely conducted online, allowing people with MS to exercise at home without serious risks.

The GEMS Plus program involves more intense exercise than usual guidelines, but previous studies have shown it remains safe. Participants might experience fatigue or sore muscles, common with exercise, but they typically don't encounter major problems.

The GEMS program follows standard exercise guidelines and is also considered safe. It involves lighter exercise, making it easier for most people to adhere to without issues.

Earlier studies provide safety data for both programs, reassuring that these exercise routines are generally safe for people with MS. Participants should feel encouraged by these findings. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Walking Exercise Programs for Multiple Sclerosis because these programs offer a fresh approach to managing MS symptoms through physical activity. Unlike standard treatments that often rely on medication, the GEMS Plus program focuses on a home-based aerobic walking exercise that goes beyond the usual physical activity guidelines for adults with MS. This approach not only encourages greater physical activity but also empowers individuals to manage their condition from the comfort of their own home, potentially improving mobility and overall quality of life.

What evidence suggests that this trial's walking exercise programs could be effective for multiple sclerosis?

Research has shown that aerobic walking exercises can help people with multiple sclerosis (MS) walk better and feel less tired. In this trial, participants will join one of two programs. The GEMS Plus program, one study arm, involves more intense walking and aims to exceed regular exercise guidelines for MS. This program is designed to enhance cognitive speed, walking ability, and overall quality of life. The standard GEMS program, another study arm, also follows exercise guidelines and has improved movement, balance, and reduced feelings of depression. Both programs offer benefits, with GEMS Plus focusing on higher intensity for potentially greater improvements. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

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

Right handedness

English as a primary language

Demonstrate low cognitive processing speed based on a Zoom-administered Symbol Digit Modalities Test

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714415301336

Feasibility study design and methods for Project GEMS There is evidence that exercise training can improve walking mobility [4], balance [5], coordination [6], fatigue [7], depression [8], and HRQOL [6] in persons ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26655434/

Feasibility study design and methods for Project GEMS The Guidelines for Exercise in Multiple Sclerosis (GEMS) program is a randomized controlled trial (RCT) examining the feasibility and efficacy of a home-based ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/22333922/

Combined training improves walking mobility in persons ... This pilot study examined changes in walking function associated with combined exercise training consisting of aerobic, resistance, and balance activities in ...

4. withpower.com withpower.com/trial/phase-sclerosis-8-2022-eb67c

Exercise Training Program for Multiple Sclerosis The GEMS program, which includes aerobic and resistance training, is designed to improve these outcomes by following MS-specific physical activity guidelines.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01074827

NCT01074827 | Improving Gait in Multiple Sclerosis (MS) Primary outcome measure is walking ability, secondary outcome measures are balance, work economy and strength. Official Title. Strength Training or Treadmill ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4778957/

GEMS Project: A Platform to Investigate Multiple Sclerosis ... Using an integrated genetic and environmental risk score, we identified subjects with twice the MS risk when compared to the average family member, and we ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01353547

Genes and Environment in Multiple Sclerosis The purpose of the research study is to identify the genetic, environmental and immune profiles that may increase a person's risk of developing multiple ...

8. mstrust.org.uk mstrust.org.uk/health-professionals/resources/service-development/generating-evidence-ms-services-gemss

Generating Evidence in MS Services (GEMSS) The MS Trust's Generating Evidence in MS Services (GEMSS) programme collected evidence about how care and health services work best for people with MS.