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Walking Exercise Programs for Multiple Sclerosis

Phase 1
Waitlist Available
Research Sponsored by Kessler Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; 6-months; 12-months
Awards & highlights
No Placebo-Only Group

Summary

This trial compares two 12mo aerobic walking exercise programs to see how they affect MS patients' cognitive processing speed, brain MRI, and other functions. 32 adults with MS will be randomly assigned to one of two conditions, monitored remotely by KF staff.

Who is the study for?
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.
What is being tested?
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).
What are the potential side effects?
Since the interventions involve aerobic walking exercises of varying intensities monitored remotely via Fitbit data and behavior coaching over Zoom for Healthcare without any pharmaceuticals involved; side effects may include typical exercise-related issues such as muscle soreness or fatigue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; 6-months; 12-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; 6-months; 12-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in cognitive processing speed
Change in resting-state functional connectivity
Secondary study objectives
Change in thalamic volume
Other study objectives
Change in aerobic fitness

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: GEMS PlusExperimental Treatment1 Intervention
Home-based aerobic walking exercise that exceeds published physical activity guidelines for adults with MS
Group II: GEMSActive Control1 Intervention
Home-based aerobic walking exercise that meets published physical activity guidelines for adults with MS

Find a Location

Who is running the clinical trial?

Kessler FoundationLead Sponsor
183 Previous Clinical Trials
11,102 Total Patients Enrolled
33 Trials studying Multiple Sclerosis
1,626 Patients Enrolled for Multiple Sclerosis

Media Library

GEMS Plus Clinical Trial Eligibility Overview. Trial Name: NCT05755061 — Phase 1
Multiple Sclerosis Research Study Groups: GEMS Plus, GEMS
Multiple Sclerosis Clinical Trial 2023: GEMS Plus Highlights & Side Effects. Trial Name: NCT05755061 — Phase 1
GEMS Plus 2023 Treatment Timeline for Medical Study. Trial Name: NCT05755061 — Phase 1
~1 spots leftby Jan 2025
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