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Aerob träning för remyelinisering vid multipel skleros

27 augusti 2026 uppdaterad av: Lindsey Wooliscroft, Oregon Health and Science University

Aerob träning för att förbättra rörligheten vid multipel skleros: optimering av design och utförande för en fullskalig multimodal remyelinering klinisk prövning

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).

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Multiple sclerosis (MS) is the most common non-traumatic disabling neurologic condition of young adulthood, affecting more than 2.5 million people worldwide. Permanent disability in MS is caused by recurrent demyelination due to episodic inflammation, followed by neuronal damage, axonal degeneration, and progressive failure of remyelination. There is an urgent need to restore activity and participation in people with MS (pwMS), and remyelination is the most promising therapeutic strategy to accomplish this goal.

Remyelination in pwMS will likely require integration of pharmacologic and rehabilitative approaches to ensure effective remyelination of appropriate neural pathways. Aerobic exercise is an ideal complement to remyelinating medications because aerobic exercise 1) improves walking function in pwMS, and 2) promotes remyelination in animal models both independently and synergistically with medications. However, there are many unknowns that need to be addressed before aerobic exercise can be explored in multimodal clinical trials for remyelination. First, it is imperative to understand how myelination impacts disability in MS, as many other factors could contribute to reduced activity and participation. Additionally, as remyelination occurs over 12 to 24 weeks, it is imperative to establish the feasibility of similar duration of aerobic exercise interventions, and explore if exercise independently influences established remyelination outcomes before integration into multimodal strategies.

This is a randomized, single-blind, parallel clinical trial of a 24-week aerobic stationary cycling intervention to determine feasibility and explore if aerobic exercise independently promotes remyelination in pwMS.

Studietyp

Interventionell

Inskrivning (Faktisk)

60

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Oregon
      • Portland, Oregon, Förenta staterna, 97239
        • Oregon Health & Science University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 64 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: MS: Cycle

Twenty-two participants in the clinical trial arm will be randomized to MS:Cycle: an aerobic exercise intervention on a stationary ergometer. Participants will exercise thrice weekly for 30 minutes with graded supervision for 24 weeks.
Beteende: Aerobic exercise

Aerobic exercise performed on a stationary ergometer for 30 minutes, thrice weekly, with graded supervision. Participants will participate in the intervention over 24 weeks.
Aktiv komparator: MS: Take Control

Twenty-two participants in the clinical trial arm will be randomized to MS: Take Control (MSTC): a monthly, hour-long MS education control group led by a trained facilitator.
Beteende: Education Group Control

A monthly, hour-long, class over various MS topics and symptoms, led by a trained facilitator.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Somatosensory Evoked Potentials
Tidsram: From baseline to week 24

Somatosensory evoked potentials (SSEPs) are a measure of functional myelination of the somatosensory tracts (i.e., the time it takes for a sensory signal to travel from the limb to the cortex of the brain). Z-scores were calculated for each leg, adjusting for participant height. A Z-score measures how many standard deviations a specific data point is from the average (mean) of a dataset (where a Z-score of 0 represents the population mean). Averaged Z-scores of the cortical latencies of both legs (i.e., P40) were compared between baseline and week 24 (post-intervention). Z-scores increase with myelin damage in multiple sclerosis (MS). Those with an average Z-score of ≥2 were considered abnormal.
From baseline to week 24

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
6-Minute Timed Walk (6MTW)
Tidsram: From baseline to week 24

An assessment of exercise tolerance
From baseline to week 24
Timed Up and Go (TUG)
Tidsram: From baseline to week 24

A test of walking agility
From baseline to week 24
Timed 25-Foot Walk (T25FW)
Tidsram: From baseline to week 24

A test of walking speed
From baseline to week 24
9 Hole Peg Test
Tidsram: From baseline to week 24

A test of upper extremity and arm function. Average of both upper extremity times in seconds.
From baseline to week 24
Multiple Sclerosis Functional Composite (MSFC)
Tidsram: From baseline to week 24

The Multiple Sclerosis Functional Composite (MSFC) is an average of the Z-scores for three individual tests measuring walking speed, upper extremity function and cognition. A Z-score measures how many standard deviations a specific data point is from the average (mean) of a dataset (where a Z-score of 0 represents the population mean). Higher MSFC scores reflect increased multiple sclerosis disability.
From baseline to week 24
Virtual Aerobic Exercise Intervention Adherence
Tidsram: From baseline to week 24

Defined as participation in at least 80% of the exercise sessions in the trial
From baseline to week 24
Virtual Education Control Group Adherence
Tidsram: From baseline to week 24

Defined as participation in at least 80% of the education group sessions in the trial
From baseline to week 24
Average Minutes Spent at Goal Heart Rate (HR) During Exercise
Tidsram: From baseline to week 24

Average number of minutes per session that MS: Cycle participants spent in their goal HR zone (>=70% HR max) during exercise sessions.
From baseline to week 24
Brain Myelin Water Fraction (MWF)
Tidsram: From baseline to week 24

MWF imaging of the corpus callosum, internal capsule, thalamus, and frontal white matter.
From baseline to week 24
Symbol Digit Modalities Test (SDMT)
Tidsram: From baseline to week 24

The Symbol Digit Modalities Test (SDMT) is a test of cognitive function. The score reflects how many correct number-symbol pairings an individual can complete in 90 seconds. Higher scores represent better cognitive processing speed and executive function. Scores can range to 0 (i.e., no correct number-symbol pairings) to a theoretically infinite score.
From baseline to week 24
VO2 Max
Tidsram: From baseline to week 24

A test of aerobic fitness
From baseline to week 24
Modified Fatigue Impact Scale (MFIS)
Tidsram: From baseline to week 24

A patient reported outcome of fatigue severity with a range of 0-84 (higher scores indicate more fatigue).
From baseline to week 24
Quality of Life in Neurological Disorders (Neuro-QoL)
Tidsram: From baseline to weeks 24

Quality of Life in Neurological Disorders (Neuro-QoL) questionnaires are patient-reported outcomes of upper and lower extremity function, depression, sleep, and self efficacy. The scores are based on T-scores which is a standardized score with a set mean of 50 and a standard deviation of 10. This scale is used to convert raw data into positive, comparable scores (e.g., T = z × 10 + 50). Increased symptom severity is reflected by lower Neuro-QoL Upper Extremity Function scores, lower Neuro-QoL Lower Extremity Function scores, higher Neuro-QoL Depression scores, higher Neuro-QoL Sleep scores, and lower Self Efficacy scores.
From baseline to weeks 24
International Physical Activity Questionnaire Short Form (IPAQ-SF)
Tidsram: From baseline to week 24

A patient reported outcome of physical activity reported as the calculated average Metabolic Equivalent of Task (MET) units per week.
From baseline to week 24

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
6-Minute Timed Walk (6MTW)
Tidsram: From baseline to week 12

An assessment of exercise tolerance
From baseline to week 12
Timed Up and Go (TUG)
Tidsram: From baseline to week 12

A test of walking agility
From baseline to week 12
Timed 25-Foot Walk (T25FW)
Tidsram: From baseline to week 12

A test of walking speed
From baseline to week 12
9 Hole Peg Test
Tidsram: From baseline to week 12

A test of upper extremity and arm function. Average of times for both upper extremities.
From baseline to week 12
Multiple Sclerosis Functional Composite (MSFC)
Tidsram: From baseline to week 12

The Multiple Sclerosis Functional Composite (MSFC) is an average of the Z-scores for three individual tests measuring walking speed, upper extremity function and cognition. A Z-score measures how many standard deviations a specific data point is from the average (mean) of a dataset (where a Z-score of 0 represents the population mean). Higher MSFC scores reflect increased multiple sclerosis disability.
From baseline to week 12
Symbol Digit Modalities Test (SDMT)
Tidsram: From baseline to week 12

The Symbol Digit Modalities Test (SDMT) test of cognitive function. The score reflects how many correct number-symbol pairings an individual can complete in 90 seconds. Higher scores represent better cognitive processing speed and executive function. Scores can range to 0 (i.e., no correct number-symbol pairings) to a theoretically infinite score.
From baseline to week 12
Modified Fatigue Impact Scale (MFIS)
Tidsram: From baseline to week 12

A patient reported outcome of fatigue severity with a range of 0-84 (higher scores indicate more fatigue).
From baseline to week 12
Somatosensory Evoked Potentials (SSEPs)
Tidsram: From baseline to week 12

Somatosensory evoked potentials (SSEPs) are a measure of functional myelination of the somatosensory tracts (i.e., the time it takes for a sensory signal to travel from the limb to the cortex). Z-scores were calculated for each leg, adjusting for participant height. A Z-score measures how many standard deviations a specific data point is from the average (mean) of a dataset (where a Z-score of 0 represents the population mean). Averaged z-scores of the cortical latencies of both legs (i.e., P40) were compared between baseline and week 12 (post-intervention). Z-scores increase with myelin damage in multiple sclerosis. Those with an average Z-score of ≥2 were considered abnormal.
From baseline to week 12
Quality of Life in Neurological Disorders (Neuro-QoL)
Tidsram: From baseline to weeks 12

Quality of Life in Neurological Disorders (Neuro-QoL) questionnaires are patient-reported outcomes of upper and lower extremity function, depression, sleep, and self efficacy. The scores are based on T-scores which is a standardized score with a set mean of 50 and a standard deviation of 10. This scale is used to convert raw data into positive, comparable scores (e.g., T = z × 10 + 50). Increased symptom severity is reflected by lower Neuro-QoL Upper Extremity Function scores, lower Neuro-QoL Lower Extremity Function scores, higher Neuro-QoL Depression scores, higher Neuro-QoL Sleep scores, and lower self efficacy scores.
From baseline to weeks 12
International Physical Activity Questionnaire Short Form (IPAQ-SF)
Tidsram: From baseline to week 12

A patient reported outcome of physical activity reported as the calculated average Metabolic Equivalent of Task (MET) units per week.
From baseline to week 12

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Oregon Health and Science University

Samarbetspartners

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
EMD Serono
National Center for Advancing Translational Sciences (NCATS)
Oregon Clinical and Translational Research Institute
Portland VA Medical Center
Medical Research Foundation, Oregon
Myelin Repair Foundation

Utredare

  • Huvudutredare: Lindsey B Wooliscroft, MD, Oregon Health and Science University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

29 april 2021

Primärt slutförande (Faktisk)

27 mars 2025

Avslutad studie (Faktisk)

27 mars 2025

Studieregistreringsdatum

Först inskickad

26 augusti 2020

Först inskickad som uppfyllde QC-kriterierna

31 augusti 2020

Första postat (Faktisk)

4 september 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • STUDY00021045
  • K23HD101667 (U.S.S. NIH-anslag/kontrakt)
  • UL1TR002369 (U.S.S. NIH-anslag/kontrakt)

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NEJ

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