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

NCT06264336 | Recruiting

• 1 other identifier: UIC AHS Pilot 2024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• Symptomatic fatigue

  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.

  Immediately (within 1 week) before and after training

• Walking speed

  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

  Immediately (within 1 week) before and after training

• Corticomotor excitability

  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.

  Immediately (within 1 week) before and after training

Secondary Outcomes (5)

• Fatigue impact

  Immediately (within 1 week) before and after training

• Walking endurance

  Immediately (within 1 week) before and after training

• Aerobic capacity

  Immediately (within 1 week) before and after training

• Visual processing speed

  Immediately (within 1 week) before and after training

• Verbal learning and memory

  Immediately (within 1 week) before and after training

Other Outcomes (4)

• Spatial walking symmetry

  Immediately (within 1 week) before and after training

• Temporal walking symmetry

  Immediately (within 1 week) before and after training

• Community ambulation

  Immediately (within 1 week) before and after training

Study Arms (2)

High-intensity interval treadmill training

EXPERIMENTAL

Walking with high intensity intervals interspersed.

Behavioral: treadmill training

Moderate-intensity continuous treadmill training

ACTIVE COMPARATOR

Continuous walking at a moderate intensity

Behavioral: treadmill training

Interventions

treadmill training 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.

High-intensity interval treadmill training; Moderate-intensity continuous treadmill training

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois Chicago

Chicago, Illinois, 60612, United States

RECRUITING

Related Publications (1)

• Cleland BT, Jeng B, Brown N, Motl RW, Madhavan S. Feasibility and efficacy of peak-velocity interval training vs. moderate-intensity walking training in people with multiple sclerosis with severe fatigue and walking impairment: A pilot randomized controlled trial. Mult Scler Relat Disord. 2025 Dec 12;106:106930. doi: 10.1016/j.msard.2025.106930. Online ahead of print.

  PMID: 41418486 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Brice T Cleland, PhD

CONTACT

312-996-9056; bcleland@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Research Assistant Professor

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 16, 2024
• Study Start: March 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: All shared data will be made available at latest by the time of associated publication or at the end of the performance period, whichever comes first. As permitted by the relevant repositories, data will be made available in perpetuity, but at minimum for 10 years.
• Access Criteria: All data described above will be shared on UIC INDIGO and UIC Research Data Glacier, university institutional and data repositories. All shared data will be accessible via persistent unique identifiers (Digital Object Identifier \[DOI\]). DOIs will be referenced in any related publications.

Locations

US (1)