CompletedNot a drug-phase studyMS (type not specified)NCT04539002

What it found

Results posted, no main test reported

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Aerobic exercise

Compared with

  • Education Group Control

Results by group

Somatosensory Evoked Potentials

From baseline to week 24

GroupValueIntervalNumber analysed
MS: Cycle3.83 Z-score3.25 (Standard Deviation)16
MS: Take Control2.87 Z-score2.57 (Standard Deviation)16
MS: Cycle3.22 Z-score3.22 (Standard Deviation)16
MS: Take Control1.92 Z-score2.7 (Standard Deviation)16

MS: Cycle

3.83

MS: Take Control

2.87

MS: Cycle

3.22

MS: Take Control

1.92

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
MS: Cycle161 (6.3%)0
MS: Take Control161 (6.3%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Somatosensory Evoked Potentials

    From baseline to week 24

    Myelin repair

Other measures (14)

  • 6-Minute Timed Walk (6MTW)

    From baseline to week 24

    Walking and mobilityPhysical function
  • Timed Up and Go (TUG)

    From baseline to week 24

    Walking and mobility
  • Timed 25-Foot Walk (T25FW)

    From baseline to week 24

    Disability progressionWalking and mobility
  • 9 Hole Peg Test

    From baseline to week 24

    Disability progressionArm and hand function
  • Multiple Sclerosis Functional Composite (MSFC)

    From baseline to week 24

    Disability progressionThinking and memoryWalking and mobilityArm and hand function
  • Virtual Aerobic Exercise Intervention Adherence

    From baseline to week 24

    Physical functionQuality of life (reported by participants)
  • Virtual Education Control Group Adherence

    From baseline to week 24

    Quality of life (reported by participants)
  • Average Minutes Spent at Goal Heart Rate (HR) During Exercise

    From baseline to week 24

    Physical function
  • Brain Myelin Water Fraction (MWF)

    From baseline to week 24

    Myelin repair
  • Symbol Digit Modalities Test (SDMT)

    From baseline to week 24

    Thinking and memory

Who could take part

MS (type not specified) · 18 to 64

Inclusion Criteria: * Physician-confirmed diagnosis of MS based on the 2017 McDonald criteria * 18-64 years old * Have access to the internet and a device that can access virtual visits * (Inclusion criteria to advance to clinical trial) Somatosensory evoked potential (SSEP) latency z-score ≥2 for P40 or inter-side difference in z-score ≥2 for P40 Exclusion Criteria: * Medical or biophysical conditions that prohibit the use of a cycle ergometer or treadmill (medical readiness to be assessed by the Activity Readiness Questionnaire (PAR-Q)) or achievement of target heart rate. * Engages in >30 minutes/week of aerobic activity regularly. * Clinically confirmed MS relapse in the last 3 months. * Changes in disease modifying therapy (DMT) for MS in the last 6 months. * Pregnant women. * Treatment with steroids for MS in the last 30 days. * Concurrent use of 4-aminopyridine or dalfampridine (medications which can alter SSEP) and unwilling to discontinue it for 2 days prior to SSEP testing. * Have a known history of severe spinal canal stenosis

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

This is a clinical trial to determine the feasibility of a stationary aerobic cycling intervention and explore if aerobic exercise independently promotes remyelination in people with multiple sclerosis (MS).

Papers

Loading reviews and guidelines…

History

    1. Started

      Apr 2021

    2. Main results due

      Mar 2025

    3. Finished

      Mar 2025

    4. Results posted

      Sept 2026

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