Clinical trial NCT03677440: Exercise Training Effects on Cognition and Brain Function in Multiple Sclerosis: Project EXACT
Official title: Exercise Training Effects on Cognition and Brain Function in Multiple Sclerosis: A Systematically-Developed Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Cognitive Impairment
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2018-09-19
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Cognitive Processing Speed
timeFrame: Baseline, Follow-up (up to 14 weeks)
measure: Thalamocortical Resting-State Functional Connectivity Region 1
timeFrame: Follow-up at 12-weeks minus baseline
measure: Change in Thalamocortical Resting State Functional Connectivity Region 2
timeFrame: Follow-up at 12-weeks minus baseline
Secondary outcomes:
measure: 3-second Paced Auditory Serial Addition Test (PASAT)
timeFrame: Baseline, Follow-up (up to 14-weeks)
measure: 2-second Paced Auditory Serial Addition Test (PASAT)
timeFrame: Baseline, Follow-up (up to 14-weeks)
measure: Pattern Comparison Test
timeFrame: Baseline, Follow-up (up to 14-weeks)
measure: Community Integration Questionnaire
timeFrame: Baseline, Follow-up (up to 14-weeks)
measure: Lawton-Brody Instrumental Activities of Daily Living
timeFrame: Baseline, Follow-up (up to 14-weeks)
measure: Multiple Sclerosis Impact Scale-29 Physical Subscale
timeFrame: Baseline, Follow-up (up to 14-weeks)
measure: Timed 25-foot Walk
timeFrame: Baseline, Follow-up (up to 14-weeks)
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Brian M Sandroff, PhD
role: PRINCIPAL_INVESTIGATOR
References: