Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Aërobe oefening voor remyelinisatie bij multiple sclerose

27 augustus 2026 bijgewerkt door: Lindsey Wooliscroft, Oregon Health and Science University

Aërobe oefening om de mobiliteit bij multiple sclerose te verbeteren: ontwerp en uitvoering optimaliseren voor een grootschalige multimodale klinische proef met remyelinisatie

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).

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

    • Oregon
      • Portland, Oregon, Verenigde Staten, 97239
        • Oregon Health & Science University

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 64 jaar (Volwassen)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.

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

Actieve vergelijker: 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.

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Somatosensory Evoked Potentials
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
6-Minute Timed Walk (6MTW)
Tijdsspanne: From baseline to week 24

An assessment of exercise tolerance

From baseline to week 24
Timed Up and Go (TUG)
Tijdsspanne: From baseline to week 24

A test of walking agility

From baseline to week 24
Timed 25-Foot Walk (T25FW)
Tijdsspanne: From baseline to week 24

A test of walking speed

From baseline to week 24
9 Hole Peg Test
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: From baseline to week 24

A test of aerobic fitness

From baseline to week 24
Modified Fatigue Impact Scale (MFIS)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
6-Minute Timed Walk (6MTW)
Tijdsspanne: From baseline to week 12

An assessment of exercise tolerance

From baseline to week 12
Timed Up and Go (TUG)
Tijdsspanne: From baseline to week 12

A test of walking agility

From baseline to week 12
Timed 25-Foot Walk (T25FW)
Tijdsspanne: From baseline to week 12

A test of walking speed

From baseline to week 12
9 Hole Peg Test
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Medewerkers

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

29 april 2021

Primaire voltooiing (Werkelijk)

27 maart 2025

Studie voltooiing (Werkelijk)

27 maart 2025

Studieregistratiedata

Eerst ingediend

26 augustus 2020

Eerst ingediend dat voldeed aan de QC-criteria

31 augustus 2020

Eerst geplaatst (Werkelijk)

4 september 2020

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 september 2026

Laatste update ingediend die voldeed aan QC-criteria

27 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • STUDY00021045
  • K23HD101667 (Subsidie/contract van de Amerikaanse NIH)
  • UL1TR002369 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .