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다발성 경화증의 재수초화를 위한 유산소 운동

2026년 8월 27일 업데이트: Lindsey Wooliscroft, Oregon Health and Science University

다발성 경화증의 이동성을 개선하기 위한 유산소 운동: 전체 규모 복합 재수초화 임상 시험을 위한 설계 및 실행 최적화

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).

연구 개요

상세 설명

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.

연구 유형

중재적

등록 (실제)

60

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Oregon
      • Portland, Oregon, 미국, 97239
        • Oregon Health & Science University

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.

활성 비교기: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Somatosensory Evoked Potentials
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
6-Minute Timed Walk (6MTW)
기간: From baseline to week 24

An assessment of exercise tolerance

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

A test of walking agility

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

A test of walking speed

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

A test of aerobic fitness

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

기타 결과 측정

결과 측정
측정값 설명
기간
6-Minute Timed Walk (6MTW)
기간: From baseline to week 12

An assessment of exercise tolerance

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

A test of walking agility

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

A test of walking speed

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 4월 29일

기본 완료 (실제)

2025년 3월 27일

연구 완료 (실제)

2025년 3월 27일

연구 등록 날짜

최초 제출

2020년 8월 26일

QC 기준을 충족하는 최초 제출

2020년 8월 31일

처음 게시됨 (실제)

2020년 9월 4일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 27일

마지막으로 확인됨

2026년 8월 1일

추가 정보

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아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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