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

NCT ID: NCT06264336

Last Updated: 2025-05-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-12-31

Brief Summary

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.

Detailed Description

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

High-intensity interval treadmill training

Walking with high intensity intervals interspersed.

Group Type: EXPERIMENTAL

treadmill training

Intervention Type: BEHAVIORAL

Participants will undergo 12 sessions (4 weeks, 3 sessions/week) of treadmill training. During each session, participants will walk for 40 min. with 5 min. of warmup and cooldown at 50% of maximal walking speed (tested each week) with 30 min. of training interposed. The type of training will be determined by the assigned treatment arm.

Moderate-intensity continuous treadmill training

Continuous walking at a moderate intensity

Group Type: ACTIVE_COMPARATOR

treadmill training

Intervention Type: BEHAVIORAL

Participants will undergo 12 sessions (4 weeks, 3 sessions/week) of treadmill training. During each session, participants will walk for 40 min. with 5 min. of warmup and cooldown at 50% of maximal walking speed (tested each week) with 30 min. of training interposed. The type of training will be determined by the assigned treatment arm.

Interventions

treadmill training

Participants will undergo 12 sessions (4 weeks, 3 sessions/week) of treadmill training. During each session, participants will walk for 40 min. with 5 min. of warmup and cooldown at 50% of maximal walking speed (tested each week) with 30 min. of training interposed. The type of training will be determined by the assigned treatment arm.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Brice Cleland

Visiting Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Illinois Chicago

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brice T Cleland, PhD

Role: CONTACT

bcleland@uic.edu

312-996-9056

Facility Contacts

Brice T Cleland, PhD

Role: primary

bcleland@uic.edu

312-996-9056

Other Identifiers

UIC AHS Pilot 2024

Identifier Type: -

Identifier Source: org_study_id