Relapsing-Remitting Multiple SclerosisNCT03244696
Behavior and Activity Monitoring in MS
A study testing Step Tracking and Water Tracking in people with Relapsing-Remitting Multiple Sclerosis, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 59 years
- Conditions the study is for
- Relapsing-Remitting Multiple Sclerosis
- What is being tested?
- Step Tracking and Water Tracking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2017to 28 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Psychology, The Ohio State University
Columbus, Ohio, 43210
About this study
Official title: 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.
Read the 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
- Being tested
- Step Tracking, Water Tracking
- 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
- Medical subject headings
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Step TrackingBehavioural
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 TrackingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Water Tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3 months, and 6 months
Secondary outcomes (8)
Changes in the Functional Architecture of the MS Brain during Working Memory
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.
Measured: Baseline and 6 months
Changes in the Functional Architecture of the MS Brain during Processing Speed
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.
Measured: Baseline and 6 months
Changes on a Self-Report Measure of Depression
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.
Measured: Baseline, 3 months, and 6 months
Changes on a Self-Report Measure of Anxiety
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.
Measured: Baseline, 3 months and 6 months
Changes on a Self-Report Measure of Perceived Stress
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.
Measured: Baseline, 3 months and 6 months
Changes on a Self-Report Measure of Quality of Life
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.
Measured: Baseline, 3 months and 6 months
Changes on a Self-Report Measure of Sleep Quality
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.
Measured: Baseline, 3 months and 6 months
Changes on a Self-Report Measure of Fatigue
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.
Measured: Baseline, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start2 Nov 2017
- Primary completion28 Jun 2021
- Study completion28 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Relapsing-Remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Principal investigator, Ruchika Prakash, Ohio State University
- Investigators
- Ruchika S Prakash, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244696
- Sponsor's protocol ID
- 2014H0483
- Status last verified
- Mar 2023
- First submitted
- 7 Aug 2017
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39207422Manglani 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.
PubMed 37690438Manglani 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.
PubMed 34309408
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavior and Activity Monitoring in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03244696
- Acronym / sponsor ID
- 2014H0483
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 28 Jun 2021 (actual)
- Study completion
- 28 Jun 2021 (actual)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Step Tracking | Experimental | Behavioral: Step TrackingParticipants 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. |
| Water Tracking | Active comparator | Behavioral: Water TrackingParticipants 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. |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Step TrackingThe 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. | Behavioural | Step Tracking |
| Water TrackingThe 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. | Behavioural | Water Tracking |
Primary outcome
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.
8 secondary outcomes
Changes in the Functional Architecture of the MS Brain during Working Memory
Time frame: Baseline and 6 months
Changes in the Functional Architecture of the MS Brain during Processing Speed
Time frame: Baseline and 6 months
Changes on a Self-Report Measure of Depression
Time frame: Baseline, 3 months, and 6 months
Changes on a Self-Report Measure of Anxiety
Time frame: Baseline, 3 months and 6 months
Changes on a Self-Report Measure of Perceived Stress
Time frame: Baseline, 3 months and 6 months
Changes on a Self-Report Measure of Quality of Life
Time frame: Baseline, 3 months and 6 months
Changes on a Self-Report Measure of Sleep Quality
Time frame: Baseline, 3 months and 6 months
Changes on a Self-Report Measure of Fatigue
Time frame: Baseline, 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Derived from this study: PubMed 39207422Phansikar 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.
- Derived from this study: PubMed 37690438Manglani 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.
- Derived from this study: PubMed 34309408Manglani 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruchika S Prakash, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Step Tracking and Water Tracking in people with Relapsing-Remitting Multiple Sclerosis, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Performance on a Latent Measure of Working Memory/Processing Speed (time frame: Baseline, 3 months, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03244696, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.