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临床试验/NCT06264336
NCT06264336已完成不适用

Effects of High-intensity Gait Training on Fatigue, Gait, and Neuroplasticity in People With Multiple Sclerosis

University of Illinois at Chicago1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2024年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Symptomatic fatigue

研究概览

简要总结

Nearly 1 million individuals in the United States have multiple sclerosis, which causes fatigue and problems with walking. Fatigue and walking problems are poorly treated, but exercise training, particularly high-intensity walking exercise, may help. This provide insight into whether high-intensity walking exercise can improve fatigue and walking problems in people with multiple sclerosis, which could improve quality of life and reduce economic burden.

详细描述

Multiple sclerosis (MS) is an immune-mediated, neurodegenerative disease of the central nervous system with a prevalence of nearly 1 million adults in the US. The pathophysiology of this disease results in two of the hallmark features of MS, namely symptomatic fatigue and walking impairment. These two features of MS are inter-related as symptomatic fatigue is often a driver of declines in walking and worsening of disability over time, and both compromise quality of life and independence. To date, fatigue and walking impairment are poorly managed through conventional disease modifying medications or rehabilitation therapy in MS.

One approach for improving fatigue and walking in MS is an appropriate dose of exercise training. Current recommendations of 30 min/day 2 days/week of low to moderate exercise training can improve symptomatic fatigue, aerobic capacity, strength, and walking endurance, and other symptoms in people with MS. This prescription is often delivered using moderate-intensity, continuous training (MCT) walking. However, improvements in fatigue and walking outcomes have been small, suggesting that MCT may not be the optimal approach. In people with stroke, high intensity, interval-based walking exercise has provided a greater stimulus than MCT for improving outcomes, but this approach has not been researched in MS.

There are a few field-wide limitations of research on exercise training, fatigue, and walking outcomes in MS. Often, researchers have (a) enrolled people with MS regardless of symptomatic fatigue and/or walking dysfunction, and this yields floor effects in outcomes and prevents conclusions on exercise as a treatment approach; (b) included people with mild disability, but not moderate or severe disability; and (c) applied exercise modalities not based on the principle of specificity (i.e., using walking training to improve fatigue and walking impairment). This project overcomes these field-wide limitations and compares effects of moderate and high intensity treadmill training on symptomatic fatigue and walking in people with MS with elevated fatigue and walking dysfunction.

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
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age ≥21 years
  • •Multiple sclerosis diagnosis
  • •Stable disease-modifying therapy (DMT) over the past 6 months
  • •Walking dysfunction (i.e., abnormal gait pattern, Expanded Disability Status Scale (EDSS) score of 4-6.5, and/or Patient-determined disease steps (PDDS) score of 3-6)
  • •Able to walk for 6 minutes at self-paced speed. Handheld assistive device is acceptable.
  • •Symptomatic fatigue (Fatigue Severity Score ≥ 4)

排除标准

  • •Adults unable to consent
  • •Pregnant women
  • •Prisoners
  • •Multiple sclerosis relapse within the last 30 days
  • •Other neurological disorders besides multiple sclerosis
  • •Cardiorespiratory or metabolic diseases (e.g., cardiac arrhythmia, uncontrolled hypertension or diabetes, chronic emphysema)
  • •Significant cognitive or communication impairment (Mini-Mental State Examination (MMSE)<21), which could impede the understanding of the purpose of procedures of the study or prevent the patient from performing the ankle-tracking task.
  • •Severe osteoporosis
  • •Failure to pass the graded exercise stress test
  • •Implanted cardiac pacemaker
  • •Metal implants in the head or face
  • •Unexplained, recurring headaches
  • •History of seizures or epilepsy
  • •Currently under medication that could increase motor excitability and lower seizure threshold
  • •Skull abnormalities or fractures
  • •Concussion within the last 6 months

研究组 & 干预措施

High-intensity interval treadmill training

Experimental

Walking with high intensity intervals interspersed.

干预措施: treadmill training (Behavioral)

Moderate-intensity continuous treadmill training

Active Comparator

Continuous walking at a moderate intensity

干预措施: treadmill training (Behavioral)

结局指标

主要结局

Symptomatic fatigue

时间窗: Immediately (within 1 week) before and after training

Change in symptomatic fatigue from pre to post training. Assessed by the Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity.

Corticomotor excitability

时间窗: Immediately (within 1 week) before and after training

Transcranial magnetic stimulation (TMS) will be used to measure change in contralateral and ipsilateral corticomotor excitability of the paretic tibialis anterior. TMS will be applied at different intensities, and the response (motor evoked potential) is measured in the paretic TMS. Corticomotor excitability will be measured as the slope of the input output curve (intensity vs. response). Higher values represent greater corticomotor excitability.

Walking speed

时间窗: Immediately (within 1 week) before and after training

Change in walking speed will be measured with the 10-m walk test. This will be quantified as the average of 3 trials a comfortable and maximal speeds. Higher values represent faster walking speeds

次要结局

  • Verbal learning and memory(Immediately (within 1 week) before and after training)
  • Fatigue impact(Immediately (within 1 week) before and after training)
  • Aerobic capacity(Immediately (within 1 week) before and after training)
  • Walking endurance(Immediately (within 1 week) before and after training)
  • Visual processing speed(Immediately (within 1 week) before and after training)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brice Cleland

Visiting Research Assistant Professor

University of Illinois at Chicago

研究点 (1)

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