Effects of Cycling and Virtual Reality on Thinking Speed in Persons With MS (PACE-MS) (PACE-MS)

October 28, 2025 updated by: Carly Wender, Kessler Foundation

Effects of a Single Bout of Moderate Intensity Aerobic Cycling Exercise Combined With Virtual Reality on Processing Speed in Persons With Multiple Sclerosis and Mobility Disability

To compare the effects of cycling exercise with different types of virtual reality on processing/thinking speed in persons with multiple sclerosis (MS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this research study is to learn how different types of cycling exercise can improve short-term processing speed, or speed of thinking, in persons with MS. In this study, we will compare the effects of cycling alone to cycling with two different types of virtual reality. Participants will complete all three cycling conditions, one per week. We are studying these types of cycling because there are currently no effective treatment options to improve processing speed in persons with MS and combining exercise with virtual reality is a promising technique.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936
        • Kessler Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Speak English as their primary language
  • Confirmed MS diagnosis by a neurologist
  • Be relapse and steroid-free for at least 30 days
  • Mild-to-moderate self-report mobility disability

Exclusion Criteria:

  • History of neurological disorders besides MS or history of uncontrolled psychiatric disorders (ex: major depression)
  • Have contraindications to exercise, based on the Physical Activity Readiness Questionnaire (PAR-Q)
  • Currently use medications that may impact cognition (ex: steroids, benzodiazepines)
  • Currently pregnant
  • Severe cognitive impairment as measured by the Modified Telephone Interview of Cognitive Status (TICS-M)
  • No indication of age-related mild cognitive impairment or dementia, based on the MOCA-Blind (i.e., MOCA-Blind ≥19).
  • High likelihood of motion sickness
  • Regular cyclist, defined as cycling for at least 150 minutes/week

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cycling Alone
Cycling alone, with no virtual reality.
Behavioral: PACE-MS
A single bout of cycling.
Experimental: Cycling with Visually Stimulating VR
Cycling with virtual reality where I only have to look at the environment while I cycle.
Behavioral: PACE-MS
A single bout of cycling.
Experimental: Cycling with Cognitively Stimulating VR
Cycling with virtual reality where I have to complete a thinking task while cycling in the virtual environment.
Behavioral: PACE-MS
A single bout of cycling.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Flanker Task (MFT)
Time Frame: Immediately before the single bout of cycling and 5 minutes after the single bout of cycling.
Response time on a computerized test is conceptualized as a measure of processing speed. Participants are tasked with identifying the direction of the central target stimulus that is flanked by either congruent (<<<<<) or incongruent (>><>>) stimuli by pressing the correct keyboard key.
Immediately before the single bout of cycling and 5 minutes after the single bout of cycling.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline mobility disability
Time Frame: Baseline visit only
Mobility disability status will be measured with a neurological exam to get an EDSS score.
Baseline visit only
Baseline Symbol Digit Modalities Test (SDMT)
Time Frame: Baseline visit only.
Processing speed will be measured with the SDMT as a more stable measure of processing speed.
Baseline visit only.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kessler Foundation

Collaborators

Consortium of Multiple Sclerosis Centers

Investigators

  • Principal Investigator: Carly Wender, PhD, Kessler Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2024

Primary Completion (Actual)

October 28, 2025

Study Completion (Actual)

October 28, 2025

Study Registration Dates

First Submitted

December 19, 2023

First Submitted That Met QC Criteria

January 3, 2024

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Estimated)

October 30, 2025

Last Update Submitted That Met QC Criteria

October 28, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R123723

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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