- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03244696
Behavior and Activity Monitoring in MS
March 22, 2023 updated by: Ruchika Prakash, Ohio State University
Behavior and Activity Monitoring in Multiple Sclerosis
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
87
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Columbus, Ohio, United States, 43210
- Department of Psychology, The Ohio State University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 59 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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.
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Active Comparator: 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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Cognitive Performance on a Latent Measure of Working Memory/Processing Speed
Time Frame: Baseline, 3 months, and 6 months
|
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.
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Baseline, 3 months, and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the Functional Architecture of the MS Brain during Working Memory
Time Frame: Baseline and 6 months
|
Before and after the intervention, participants will undergo a brain imaging scan using functional Magnetic Resonance Imaging (fMRI) technology.
Network strength in the working memory connectome during the NBack task will be the primary fMRI-based neuroimaging measure.
Higher network strength in the working memory connectome represent greater connections between brain edges associated with high working memory performance.
Participants in the physical activity group will show increased network strength in a connectome-based model of working memory performance.
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Baseline and 6 months
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Changes in the Functional Architecture of the MS Brain during Processing Speed
Time Frame: Baseline and 6 months
|
Before and after the intervention, participants will undergo a brain imaging scan using functional Magnetic Resonance Imaging (fMRI) technology.
Network strength in the processing speed neuromaker during the Symbol Digit Modalities Test will be the outcome variable.
Higher network strength in the processing speed neuromarker represent greater connections between brain edges associated with high processing speed performance.
Participants in the physical activity group will show increased network strength in this neuromarker of processing speed.
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Baseline and 6 months
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Changes on a Self-Report Measure of Depression
Time Frame: Baseline, 3 months, and 6 months
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Participants will be administered Beck Depression Inventory-II before, at mid-point, and after the intervention.
This measure assesses self-reported depressive symptoms with a range of 0-63 with higher scores characterizing higher endorsement of depressive symptoms.
Changes in scores will indicate effects of the intervention on symptoms of depression.
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Baseline, 3 months, and 6 months
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Changes on a Self-Report Measure of Anxiety
Time Frame: Baseline, 3 months and 6 months
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Participants will be administered the Penn State Worry Questionnaire before, at mid-point and after the intervention.
This measure assesses self-reported worry symptoms with a range of 16-80.
High scores on this measure represent higher levels of chronic worrying.
Change on this measure will be assessed to determine the impact of the intervention on symptoms of worry.
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Baseline, 3 months and 6 months
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Changes on a Self-Report Measure of Perceived Stress
Time Frame: Baseline, 3 months and 6 months
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Participants will be administered the Perceived Stress Scale before, at mid-point and after the intervention.
This measure assesses perceived stress with a range of 0-40.
High scores on the perceived stress scale represent higher levels of stress.
Change on this measure will indicate impact of the intervention on symptoms of stress.
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Baseline, 3 months and 6 months
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Changes on a Self-Report Measure of Quality of Life
Time Frame: Baseline, 3 months and 6 months
|
Participants will be administered the Satisfaction with Life Scale and the World Health Organization Quality of Life Scale before, at mid-point, and after the intervention.
Standardized scores for the two measures will be merged to create a composite score for quality of life.
High scores on this composite measure would represent higher quality of life.
Differences in the composite score of quality of life will reveal changes in quality of life as a function of the intervention.
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Baseline, 3 months and 6 months
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Changes on a Self-Report Measure of Sleep Quality
Time Frame: Baseline, 3 months and 6 months
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Participants will be administered the Pittsburgh Sleep Quality Index before, at mid-point, and after the intervention.
This measure assesses sleep quality with a range of 0-21.
Higher score on this measure represents greater difficulty with sleep.
Score changes on this measure will indicate changes in sleep quality as a function of the intervention.
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Baseline, 3 months and 6 months
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Changes on a Self-Report Measure of Fatigue
Time Frame: Baseline, 3 months and 6 months
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Participants will be administered the Modified Fatigue Impact Scale before, at mid-point and after the intervention.
This measure assesses self-reported fatigue with a range of 0-84.
High scores on this measure represent higher levels of experienced fatigue.
Differences in scores on this measure will indicate changes in fatigue as a function of the intervention.
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Baseline, 3 months and 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ruchika S Prakash, PhD, Ohio State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 2, 2017
Primary Completion (Actual)
June 28, 2021
Study Completion (Actual)
June 28, 2021
Study Registration Dates
First Submitted
August 7, 2017
First Submitted That Met QC Criteria
August 7, 2017
First Posted (Actual)
August 9, 2017
Study Record Updates
Last Update Posted (Actual)
March 24, 2023
Last Update Submitted That Met QC Criteria
March 22, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Keywords
- Multiple Sclerosis
- Physical Activity
- Immune System Diseases
- Nervous System Diseases
- Neurodegenerative Disease
- Hydration
- Lifestyle Intervention
- Walking
- Sclerosis
- Demyelinating Diseases
- Inflammatory Biomarkers
- Autoimmune Diseases of the Nervous System
- Demyelinating Autoimmune Diseases, Central Nervous System
- Health Behavior Tracking
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014H0483
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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