Behavior and Activity Monitoring in MS
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional

Summary: 
      The investigators propose to conduct a randomized 6-month intervention study comparing
      cognitive functioning in individuals with relapsing-remitting multiple sclerosis assigned to
      either a physical activity or an active water-intake control group. Individuals will complete
      pre-, mid- and post-assessments of cognitive, physical, and behavioral functioning.
    

Detailed description: 
      Interventions to increase physical activity through aerobic exercise are some of the only
      known treatment options to improve domains of cognition such as executive function. While
      increased physical activity is associated with preserved cortical functioning during
      exogenous executive functioning tasks in older adults, little is known about the relationship
      between physical activity and executive functioning in multiple sclerosis. Thus, the
      investigators propose to conduct a randomized 6-month accelerometry-based intervention
      designed to increase overall physical activity in sedentary relapsing-remitting multiple
      sclerosis with known cognitive challenges. The overall objective is to determine how a
      6-month activity tracking intervention impacts the behavioral, neural and mechanistic
      associations between physical activity and cognitive functioning. All individuals who contact
      the Clinical Neuroscience Laboratory (CNL) with interest in this study will undergo a
      phone/online screening assessing inclusion/exclusion criteria. Those participants meeting I/E
      criteria will be invited to the lab for 2 pre-assessment sessions, one session at midpoint,
      and 2 post-assessment sessions at the completion of the 6 month intervention. Participants
      will also be asked to complete a number of online questionnaires following the first
      assessment session. The two pre-assessments will involve a through measure of cognitive
      functioning, both through the use of neuropsychological batteries and neuroimaging, and
      inflammatory markers through collection of a blood sample. Following the pre-assessment
      sessions, conducted by blind personnel, participants will be randomized to one of the two
      groups. Participants will be asked to self-monitor their assigned health behavior with the
      aid of a behavioral tracker (accelerometer or smart water bottle). Via a mobile application
      designed by the laboratory, participants will receive daily and weekly summaries of their
      health behavior progress, and motivational materials to encourage goal attainment. The
      6-month intervention will involve minimal contact from study coordinators. Participants who
      do not adhere to study goals will be contacted by a study coordinator via phone who will use
      motivational interviewing to promote behavior change. Following the 6-month intervention the
      2 assessment sessions will be repeated to obtain post-intervention data for comparison.
    

Intervention name(s): Step Tracking; Water Tracking
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The step tracking intervention is designed to increase physical activity through the use of self-monitoring and brief motivational materials. The motivational materials will be delivered at various points during the intervention. Participants are not required to access and read these materials, however, the hope is these materials will aid in study and goal adherence. Engagement in the intervention will be tracked by the experimenters using the behavioral data gathered by the tracker.; The water tracking intervention is designed to increase water intake, to a healthy level, through the use of self-monitoring and brief motivational materials.The motivational materials will be delivered at various points during the intervention. Participants are not required to access and read these materials, however, the hope is these materials will aid in study and goal adherence. Engagement in the intervention will be tracked by the experimenters using the behavioral data gathered by the tracker.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Sclerosis; Demyelinating Autoimmune Diseases, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Immune System Diseases; Physical Activity; Walking; Hydration; Lifestyle Intervention; Health Behavior Tracking; Inflammatory Biomarkers; Neurodegenerative Disease