Aerobic Exercise to Improve Mobility in Multiple Sclerosis: Optimizing Design and Execution for a Full-scale Multimodal Remyelination Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Somatosensory Evoked Potentials
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Single-blind, randomized, controlled
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Aerobic exercise (Behavioral)
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.
干预措施: Education Group Control (Behavioral)
结局指标
主要结局
Somatosensory Evoked Potentials
时间窗: 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.
次要结局
- 9 Hole Peg Test(From baseline to week 24)
- Multiple Sclerosis Functional Composite (MSFC)(From baseline to week 24)
- 6-Minute Timed Walk (6MTW)(From baseline to week 24)
- Symbol Digit Modalities Test (SDMT)(From baseline to week 24)
- International Physical Activity Questionnaire Short Form (IPAQ-SF)(From baseline to week 24)
- Brain Myelin Water Fraction (MWF)(From baseline to week 24)
- Virtual Aerobic Exercise Intervention Adherence(From baseline to week 24)
- Virtual Education Control Group Adherence(From baseline to week 24)
- Average Minutes Spent at Goal Heart Rate (HR) During Exercise(From baseline to week 24)
- VO2 Max(From baseline to week 24)
- Quality of Life in Neurological Disorders (Neuro-QoL)(From baseline to weeks 24)
- Timed 25-Foot Walk (T25FW)(From baseline to week 24)
- Timed Up and Go (TUG)(From baseline to week 24)
- Modified Fatigue Impact Scale (MFIS)(From baseline to week 24)
研究者
Lindsey Wooliscroft
Assistant Professor
Oregon Health and Science University