- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04539002
다발성 경화증의 재수초화를 위한 유산소 운동
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
상태
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
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Oregon
-
Portland, Oregon, 미국, 97239
- Oregon Health & Science University
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
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
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
협력자
수사관
- 수석 연구원: Lindsey B Wooliscroft, MD, Oregon Health and Science University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- STUDY00021045
- K23HD101667 (미국 NIH 보조금/계약)
- UL1TR002369 (미국 NIH 보조금/계약)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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