Behavior and Activity Monitoring in MS

NCT03244696 | Completed

• 1 other identifier: 2014H0483
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Relapsing-Remitting Multiple Sclerosis

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

Outcome Measures

Primary Outcomes (1)

• Change in Cognitive Performance on a Latent Measure of Working Memory/Processing Speed

  Change in a latent factor of working memory/processing speed will be examined from pre to post intervention. This latent factor will be created using baseline performance on measures from the Minimal Assessment of Cognitive Functioning in Multiple Sclerosis battery (MACFIMS), the NIH Toolbox Cognition Battery (NIHTB-CB), and the processing speed and working memory measures from the Wechsler Adult Intelligence Scale (WAIS-IV) before, during (at midpoint), and after the intervention. Higher scores on this factor represent better working memory/processing speed performance. Investigators hypothesize changes in cognitive performance, specifically in the domains of working memory and processing speed.

  Baseline, 3 months, and 6 months

Secondary Outcomes (8)

• Changes in the Functional Architecture of the MS Brain during Working Memory

  Baseline and 6 months

• Changes in the Functional Architecture of the MS Brain during Processing Speed

  Baseline and 6 months

• Changes on a Self-Report Measure of Depression

  Baseline, 3 months, and 6 months

• Changes on a Self-Report Measure of Anxiety

  Baseline, 3 months and 6 months

• Changes on a Self-Report Measure of Perceived Stress

  Baseline, 3 months and 6 months

Study Arms (2)

Step Tracking

EXPERIMENTAL

Participants will track their physical activity in steps using an accelerometer for a period of 6 months. Participants will monitor their overall step-count using the accelerometer, and daily and weekly summaries of their progress provided by the experimenters.

Behavioral: Step Tracking

Water Tracking

ACTIVE COMPARATOR

Participants will track their water-intake using a smart water bottle for a period of 6 months. Participants will monitor their overall water consumption using a smart water bottle, and daily and weekly summaries of their progress provided by the experimenters.

Behavioral: Water Tracking

Interventions

Step Tracking BEHAVIORAL

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.

Step Tracking

Water Tracking BEHAVIORAL

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.

Water Tracking

Eligibility Criteria

• Age: 30 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinically definite diagnosis of Relapsing-Remitting Multiple Sclerosis
• Score higher than 23 on the Mini-Mental Status Examination (MMSE)
• Expanded Disability Status Scale (EDSS) under 5.5
• Right-handed

You may not qualify if:

• Clinically isolated syndrome or progressive MS subtype
• Presence of any other neurological disorders
• Presence of psychiatric disorder diagnosed by a licensed mental health provider in the last two years
• Clinically definite relapse or use of high dose corticosteroids within the last 30 days
• Recreational drug use in the last 6 months
• Without access to a smart phone or no access to the internet
• Current use of accelerometer, pedometer, and/or physical activity monitoring equipment
• Presence of ferromagnetic implanted devices or self-reported claustrophobia

Sponsors & Collaborators

• Ohio State University: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

Department of Psychology, The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (3)

• Phansikar M, Duraney EJ, Manglani HR, Shankar A, Roberts C, Andridge R, Nicholas JA, Petosa R, Prakash RS. TRACking health behavior in people with multiple sclerosis: Effects of a randomized trial on physical activity and working memory. Rehabil Psychol. 2025 Aug;70(3):227-239. doi: 10.1037/rep0000578. Epub 2024 Aug 29.

  PMID: 39207422 DERIVED

• Manglani HR, Phansikar M, Duraney EJ, McKenna MR, Canter R, Nicholas JA, Andridge R, Prakash RS. Accelerometry measures of physical activity and sedentary behavior: Associations with cognitive functioning in MS. Mult Scler Relat Disord. 2023 Nov;79:104963. doi: 10.1016/j.msard.2023.104963. Epub 2023 Aug 28.

  PMID: 37690438 DERIVED

• Manglani HR, Fountain-Zaragoza S, Shankar A, Nicholas JA, Prakash RS. Employing Connectome-Based Models to Predict Working Memory in Multiple Sclerosis. Brain Connect. 2022 Aug;12(6):502-514. doi: 10.1089/brain.2021.0037. Epub 2021 Sep 28.

  PMID: 34309408 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis; Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Immune System Diseases; Motor Activity; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukoencephalopathies; Brain Diseases; Central Nervous System Diseases; Behavior

Study Officials

• Ruchika S Prakash, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ruchika Prakash, Associate Professor

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 9, 2017
• Study Start: November 2, 2017
• Primary Completion: June 28, 2021
• Study Completion: June 28, 2021
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)