Multiple Sclerosis
Conditions
Keywords
remyelination, demyelination, physical activity, multiple sclerosis
Brief summary
This observational, longitudinal study will examine whether physical activity and other potentially modifiable lifestyle factors are associated with changes in myelin, the protective coating around nerve fibers, in older adults with multiple sclerosis (MS). Participants will undergo magnetic resonance imaging (MRI) scans to measure myelin throughout the central nervous system and will wear wrist-worn activity trackers to assess physical activity over time.
Detailed description
The primary aim of this study is to explore clinical variables and potentially modifiable risk factors that are associated with improved myelination (both enhanced remyelination and reduced demyelination) in older adults living with multiple sclerosis. The emphasis here will be on discovery and generation of pilot data to support further definitive longitudinal observational studies, and ultimately, clinical trials on behavioral and/or pharmaceutical interventions to prevent demyelination and promote remyelination in people living with MS. Participants will be categorized based on whether they meet or exceed the current physical activity guidelines of at least 150 minutes per week of moderate-intensity aerobic physical activity, 75 minutes per week of vigorous-intensity aerobic physical activity, or an equivalent combination. At both baseline and 6 months, MRI and clinical assessments will be obtained, and chart review will be performed. Participants will wear a wrist-worn physical activity monitor and answer monthly questionnaires (assessed via REDCap survey) throughout the study period. Linear regression will be performed to estimate the effect size of various physical activity variables (step count, sedentary time, and time spent in light/moderate/vigorous physical activity, aerobic capacity and overall strength) with 6-month change in myelination.
Interventions
OTHERObservation
No intervention is administered. Participants undergo observational assessments including MRI, wearable activity monitoring, and questionnaires.
Sponsors
University of Washington
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of multiple sclerosis * Independent with ambulation (able to walk 500m without aid) * Disease duration \>10 years * Age 50 to 70 years (inclusive) * Be able to read, speak, and understand English
Exclusion criteria
* Diagnosis of other neurologic disease that would interfere with interpretation such as stroke, myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), neuromyelitis optica (NMO), and sarcoidosis. * Inability to complete study procedures (including obtaining MRI at BMIC and using Fitbit connected to smartphone) * Currently participating in another clinical trial on remyelination * Pregnancy. (Pregnancy status will be asked at screening and before each MRI. Pregnancy testing will not be offered as part of this study.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative MRI-derived myelin measure | Baseline and 6 months | Change in MRI-derived measures of myelin content within the central nervous system. Specifically, the investigators will use macromolecular proton fraction (MPF), a quantitative MRI parameter which describes the magnetization transfer effect and defined as the relative amount of protons bound to biological macromolecules with restricted molecular motion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total step count | Continuously collected during the 6-month study period | Total step count will measured using wrist-worn activity tracker. |
| Self-reported physical activity | Baseline and monthly for the 6-month study period | Physical activity will be measured with the International Physical Activity Questionnaire-Short Form (IPAQ-SF). This questionnaire will ask participants about their moderate and vigorous physical activity and time spent walking, to give a total sum score of Metabolic Equivalent of Task (MET). Higher calculated (MET) scores indicate greater physical activity. |
| Multiple Sclerosis Functional Composite (MSFC) | baseline and 6 months | The MSFC assesses walking function, hand function, and cognitive function and gives a composite score. |
| Low Contrast Letter Acuity | Baseline and 6 months | The LCLA assesses visual function |
| Time spent in moderate-to-vigorous physical activity (MVPA) | Throughout the 6-month period | MVPA will be measured via wrist-worn physical activity monitor |
| Sedentary Time | Throughout the 6-month period | Sedentary Time will be measured via wrist-worn fitness tracker |
| Self-reported sedentary time | Baseline and monthly throughout the 6-month period | Self-reported sedentary time will be measured with the International Physical Activity Questionnaire-Short Form (IPAQ-SF). This questionnaire will ask participants about their time spent sitting over the past 7 days, as an estimate of sedentary time. |
Countries
United States
Contacts
CONTACTSusan R Robles, BS
Outcome results
None listed