Behavior and Activity Monitoring in MS

NCT ID: NCT03244696

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-02
• Study Completion Date: 2021-06-28

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.

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.

Conditions

Relapsing-Remitting Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Step Tracking

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.

Group Type: EXPERIMENTAL

Step Tracking

Intervention Type: 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.

Water Tracking

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.

Group Type: ACTIVE_COMPARATOR

Water Tracking

Intervention Type: 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.

Interventions

Step Tracking

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.

Intervention Type: BEHAVIORAL

Water Tracking

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Multiple Sclerosis Society

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Ruchika Prakash

Ruchika Prakash, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ruchika S Prakash, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

Department of Psychology, The Ohio State University

Columbus, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39207422 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37690438 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34309408 (View on PubMed)

Other Identifiers

2014H0483

Identifier Type: -

Identifier Source: org_study_id