Behavior and Activity Monitoring in MS



Status:Recruiting
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:30 - 59
Updated:1/31/2019
Start Date:November 2, 2017
End Date:January 2020
Contact:Heena Manglani, BA
Email:manglani.2@osu.edu
Phone:614-292-9568

Use our guide to learn which trials are right for you!

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.

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.

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) of 1 to 5.5

- Presence of cognitive impairment - defined as scoring above 22 on the Multiple
Sclerosis Neuropsychological Questionnaire-Informant Report OR above 24 on the
Multiple Sclerosis Neuropsychological Questionnaire-Self Report

- Absence of comorbid neurological disorders

- Absence of professionally diagnosed psychiatric disorder in the last 2 years

- Relapse and corticosteroid free for the last 30 days

- Absence of recreational drug use in the last 6 months

- Access to a smart phone and the internet for the study

- No current use of tracking devices for health behavior monitoring

Exclusion Criteria:

- Clinically isolated syndrome or progressive MS subtype

- Score below 23 on the MMSE

- EDSS of less than 1 or 5.5 or higher

- No presence of cognitive impairment

- Presence of any other neurological disorders

- Professionally diagnosed psychiatric disorder in the last 2 years

- Clinically definite relapse or use of high dose corticosteroids within the last 30
days

- Recreational drug use in the last 6 months

- No access to a smart phone or no access to the internet

- Current use of accelerometer, pedometer, and/or physical activity monitoring equipment
We found this trial at
1
site
Columbus, Ohio 43210
Phone: 614-292-8462
?
mi
from
Columbus, OH
Click here to add this to my saved trials