NCT03677440Completed
Exercise Training Effects on Cognition and Brain Function in Multiple Sclerosis: Project EXACT
Exercise Training Effects on Cognition and Brain Function in Multiple Sclerosis: A Systematically-Developed Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 5 Jun 2025
Brief summary (registry, in English)
Cognitive impairment is highly prevalent, poorly-managed, and disabling in persons with MS and exercise training might represent a promising approach to manage this symptom of the disease. The proposed study aims to examine the effects of 3-months of supervised, progressive (both intensity and duration) treadmill walking exercise training (designed based on pilot work and American College of Sports Medicine guidelines) compared with an active control condition (i.e., stretching-and-toning activities) on cognitive processing speed and functional MRI outcomes in 88 cognitively-impaired persons with MS. This study is critical for providing evidence supporting treadmill walking exercise training as a behavioral approach for managing slowed cognitive processing speed (i.e., the most common MS-related cognitive impairment) and improving brain health in persons with MS.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 43 (actual)
- First submitted
- 14 Sept 2018
- Start date
- 5 Feb 2019
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- Kessler Foundation
- Diseases
- Multiple sclerosis
- NCT number
- NCT03677440
What you commit to
- Study type: Interventional
- Participants enrolled: 43
- From 5 Feb 2019 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- All participants will:
- Be between the ages of 18-65
- Have a clinically definite MS diagnosis based on established criteria
- Be fully-ambulatory based on Expanded Disability Status Scale (EDSS) scores between 0-4.0
- Demonstrate slowed CPS based on initial SDMT scores at least 1 SD below the regression-based normative score for healthy controls (i.e., 16th percentile)
- Be relapse-free and will not have acutely taken corticosteroids for at least 30 days (i.e., relative neurologic stability)
- Not have a history of major depressive disorder, schizophrenia, bipolar disorder I or II, or substance-abuse disorders.
- Not be taking medications that can affect cognition (e.g., antipsychotics, benzodiazepines).
- Be right-handed
- Have corrected vision better than 20/80
- Not have known/diagnosed cardiovascular, metabolic, or renal disease. Individuals with known/diagnosed cardiovascular, metabolic, or renal disease who are asymptomatic will be included only with a physician's approval.
- Demonstrate scores on the Mini-Mental State Examination (MMSE) of 21 or higher (no decisional impairment)
- Be on a stable disease-modifying therapy regimen (i.e., at least 6 months prior to study enrollment).
- Have a low risk for contraindications for MRI based on not having metal (e.g., non-MRI compatible aneurysm clips, metal shards in the body or eyes, or recently placed surgical hardware) or electronic devices (e.g., pacemaker, cochlear implant) within the body.
- Not be pregnant
- Not be engaging in ≥ 150 min of moderate-to-vigorous physical activity (i.e., not meeting public health guidelines for physical activity) per week
- Not be actively engaging in cognitive rehabilitation, or participating in regular brain fitness activities
- Demonstrate systolic blood pressure values of \< 200 mmHg or diastolic blood pressure values \< 110 mmHg at rest
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kessler Foundation Coordinator of this site? Confirm its status | West Orange | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.