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Aerobic-Übungen zur Remyelinisierung bei Multipler Sklerose

27. August 2026 aktualisiert von: Lindsey Wooliscroft, Oregon Health and Science University

Aerobic-Übungen zur Verbesserung der Mobilität bei Multipler Sklerose: Optimierung von Design und Ausführung für eine umfassende klinische Studie zur multimodalen Remyelinisierung

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).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Oregon
      • Portland, Oregon, Vereinigte Staaten, 97239
        • Oregon Health & Science University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 64 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verhalten: 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.
Aktiver 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.
Verhalten: Education Group Control

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Somatosensory Evoked Potentials
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
6-Minute Timed Walk (6MTW)
Zeitfenster: From baseline to week 24

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

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

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

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

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
6-Minute Timed Walk (6MTW)
Zeitfenster: From baseline to week 12

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

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

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Oregon Health and Science University

Mitarbeiter

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

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

29. April 2021

Primärer Abschluss (Tatsächlich)

27. März 2025

Studienabschluss (Tatsächlich)

27. März 2025

Studienanmeldedaten

Zuerst eingereicht

26. August 2020

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

31. August 2020

Zuerst gepostet (Tatsächlich)

4. September 2020

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

23. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

27. August 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • STUDY00021045
  • K23HD101667 (US NIH Stipendium/Vertrag)
  • UL1TR002369 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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