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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

Study 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.Check my eligibility

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).See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; 6-months; 12-months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in cognitive processing speed

Change in resting-state functional connectivity

Secondary outcome measures

Change in thalamic volume

Other outcome measures

Change in aerobic fitness

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Kessler FoundationLead Sponsor

174 Previous Clinical Trials

10,707 Total Patients Enrolled

32 Trials studying Multiple Sclerosis

1,586 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial open to participants who are over 40 years of age?

"According to the stated requirements, those who are eligible for this trial must be between 16 and 65 years of age."

Answered by AI

What are the criteria for inclusion in this research endeavor?

"In order to be eligible for this medical research, individuals must possess a diagnosis of multiple sclerosis and fall between ages 16-65. At present, the study is looking to enroll 32 participants."

Answered by AI

Has GEMS Plus been sanctioned by the FDA?

"With only a few studies having been conducted to assess its safety and efficacy, GEMS Plus was given an initial score of 1."

Answered by AI

Is participation in this clinical research still available?

"Affirmative. Clinicaltrials.gov data suggests that this medical study, which was first launched on February 1st 2023, is actively recruiting participants. Approximately 32 patients need to be recruited from a single location."

Answered by AI

What is the cap on enrollees for this clinical investigation?

"Yes, there is evidence on clinicaltrials.gov to suggest that this trial is actively enrolling participants. It was first announced on February 1st 2023 and has since been updated once, as of the 23rd of February 2023. The study's goal is to secure 32 patients at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

WEBCAMS: Walking Exercise for Brain and Cognition in Adults With Multiple Sclerosis

Brian Sandroff 2023. "WEBCAMS: Walking Exercise for Brain and Cognition in Adults With Multiple Sclerosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05755061.

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