多发性硬化症髓鞘再生的有氧运动
改善多发性硬化症活动能力的有氧运动:优化全面多模式髓鞘再生临床试验的设计和执行
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).
研究概览
地位
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Oregon
-
Portland、Oregon、美国、97239
- Oregon Health & Science University
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的: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. |
|
有源比较器: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. |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Somatosensory Evoked Potentials
大体时间: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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
6-Minute Timed Walk (6MTW)
大体时间:From baseline to week 24
|
An assessment of exercise tolerance |
From baseline to week 24
|
|
Timed Up and Go (TUG)
大体时间:From baseline to week 24
|
A test of walking agility |
From baseline to week 24
|
|
Timed 25-Foot Walk (T25FW)
大体时间:From baseline to week 24
|
A test of walking speed |
From baseline to week 24
|
|
9 Hole Peg Test
大体时间: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)
大体时间: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
大体时间: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
大体时间: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
大体时间: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)
大体时间: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)
大体时间: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
大体时间:From baseline to week 24
|
A test of aerobic fitness |
From baseline to week 24
|
|
Modified Fatigue Impact Scale (MFIS)
大体时间: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)
大体时间: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)
大体时间: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
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
6-Minute Timed Walk (6MTW)
大体时间:From baseline to week 12
|
An assessment of exercise tolerance |
From baseline to week 12
|
|
Timed Up and Go (TUG)
大体时间:From baseline to week 12
|
A test of walking agility |
From baseline to week 12
|
|
Timed 25-Foot Walk (T25FW)
大体时间:From baseline to week 12
|
A test of walking speed |
From baseline to week 12
|
|
9 Hole Peg Test
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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
|
合作者和调查者
合作者
调查人员
- 首席研究员:Lindsey B Wooliscroft, MD、Oregon Health and Science University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- STUDY00021045
- K23HD101667 (美国 NIH 拨款/合同)
- UL1TR002369 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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