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NCT05755061 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Multiple Sclerosis and Relapsing Remitting Multiple Sclerosis, sponsored by Kessler Foundation.

Active
Registry status
Phase 1
Development phase
31
Enrollment target
1
Study location

NCT05755061 is a Phase 1 study of Multiple Sclerosis and Relapsing Remitting Multiple Sclerosis that is active but no longer recruiting, run by Kessler Foundation. The registered enrollment target is 31 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05755061, a Phase 1 study of Multiple Sclerosis and Relapsing Remitting Multiple Sclerosis, is active but no longer recruiting, sponsored by Kessler Foundation.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
31 participants
Enrollment target
1
Study location

Study Summary

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 w

Interventions

  • BEHAVIORAL GEMS Plus
  • BEHAVIORAL GEMS

Study Locations (1)

New Jersey

  • Kessler Foundation - West Orange

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2023-02-01
Est. Completion 2026-01-31
Phase Phase 1

Sponsor

Kessler Foundation

104 total trials

What the Registry Record Tells You About NCT05755061

The ClinicalTrials.gov registry entry for NCT05755061 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (95% lower). The listed sponsor is Kessler Foundation, which has 104 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which GEMS Plus is the first listed.

NCT05755061 reports 1 study location spanning 1 distinct geographic area - top geographies include New Jersey.

Frequently Asked Questions

What is clinical trial NCT05755061 about?

NCT05755061 is a clinical study titled "WEBCAMS: Walking Exercise for Brain and Cognition in Adults With Multiple Sclerosis". 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 de...

What is the current status of trial NCT05755061?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2023-02-01. Estimated completion is 2026-01-31.

What conditions does trial NCT05755061 study?

This clinical trial studies the following conditions: Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis.

What interventions are being tested in trial NCT05755061?

The interventions under investigation include: GEMS Plus (BEHAVIORAL), GEMS (BEHAVIORAL).

Who is sponsoring clinical trial NCT05755061?

This trial is sponsored by Kessler Foundation, which has 104 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05755061 being conducted?

This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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