Internet-Delivered Lifestyle Physical Activity Intervention for Cognitive Processing Speed in Multiple Sclerosis
BIPAMS-Cog
2 other identifiers
interventional
280
1 country
1
Brief Summary
We propose a highly-informed, well-designed randomized controlled trial (RCT) that is critical for providing Class I evidence regarding an Internet-delivered physical activity (PA) intervention as a behavioral approach for managing slowed cognitive processing speed (CPS; the most common and perhaps most burdensome MS-related cognitive impairment) and its second learning and memory, symptomatic, and quality of life (QOL) correlates among fully-ambulatory persons with multiple sclerosis (MS) who present with CPS impairment. Such an approach will involve a single-blind, RCT that examines the effects of a remotely-delivered, Internet-based PA intervention compared with an active control condition for yielding immediate and sustained improvements in CPS, learning and memory, symptomatic, and QOL outcomes among persons with mild MS-related ambulatory impairment who demonstrate impaired CPS. The primary outcome is the raw (unadjusted), oral Symbol Digit Modalities Test (SDMT) score as a neuropsychological measure of CPS, and this will be collected remotely via screen-sharing technology. The secondary outcomes include an objective neuropsychological measure of learning and memory (California Verbal Learning Test-II) collected remotely via screen-sharing technology, self-report measures of fatigue (Fatigue Severity Scale), depressive symptoms and anxiety (Hospital Anxiety and Depression Scale), pain (Short-Form, McGill Pain Questionnaire) and QOL (Multiple Sclerosis Impact Scale-29) that will be captured remotely using Qualtrics. The tertiary outcome is accelerometry as an objective, device-based measure of steps/day that will be delivered and returned via pre-paid, pre-addressed envelopes through the United States Postal Service for generating a minimal clinically important difference value that guides the prescription of free-living PA for managing CPS impairment in clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-sclerosis
Started Mar 2023
Longer than P75 for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2020
CompletedFirst Posted
Study publicly available on registry
August 19, 2020
CompletedStudy Start
First participant enrolled
March 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
January 6, 2026
January 1, 2026
3.7 years
August 10, 2020
January 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cognition
Symbol Digit Modalities Test (SDMT); scoring involves summing the correct number of substitutions within the 90 second interval (max = 110), higher score indicates better outcomes.
Changes in cognition scores from Baseline, 6-Month, and 12-Month
Secondary Outcomes (5)
Fatigue Severity
Changes in fatigue from Baseline, 6-Months, and 12-Months
Fatigue Impact
Changes in fatigue from Baseline, 6-Months, and 12-Months
Depressive Symptoms
Changes in depressive symptoms from Baseline, 6-Month, and 12-Month
Anxiety
Changes in anxiety symptoms from Baseline, 6-Month, and 12-Month
Quality of Life (QOL)
Changes in quality of life from Baseline, 6-Month, and 12-Month
Other Outcomes (1)
Accelerometry
Changes in accelerometry data from Baseline, 6-Month, and 12-Month
Study Arms (2)
Behavioral Intervention for Physical Activity in MS (BIPAMS)
EXPERIMENTALThe current behavioral intervention consists of two primary components; an internet website and oneonone video chats with a behavioral coach.The internet website involves content delivered through interactive video courses.The interactive video courses are based on elements of social cognitive theory.Each course consists of an introduction,the primary content,and a take home message.The interactive courses include embedded,supplementary options such as videos on content and worksheets related to the topic.A pedometer is provided for tracking steps,and these steps will be entered into the website so progress can be monitored.The chats support adherence to the intervention,discussion of website material,supportive accountability,and reporting of adverse events/injuries.The chats are conducted facetoface through an online videoconferencing platform.The chats occur 7 times during the first 2 months,4 times during the second 2 months,and twice during the final 2 months of the intervention.
Wellness for MS (WellMS)
SHAM COMPARATORProvides an internet website and oneonone video chats that discuss materials about self-managing multiple sclerosis (MS) consequences and health indicators through methods other than physical activity.The materials are transformations of brochures provided by the National MS Society,including Gait or Walking Problems:The Basic Facts;MS and Your Emotions;Pain:The Basic Facts; Solving Cognitive Problems;Taming Stress in MS;Food for Thought:MS and Nutrition;and Vitamins,Minerals,and Herbs:An Introduction.The delivery of the internet materials and chat sessions will occur on the same time schedule and frequency as the intervention condition,and will have a comparable time commitment. The control condition will not involve tracking steps and a pedometer with not be provided.
Interventions
A behavioral intervention that involves an internet website and one-on-one video coaching calls for increasing wellness in people with MS.
A behavioral intervention that involves an internet website and one-on-one video coaching calls for increasing physical activity in people with MS.
Eligibility Criteria
You may qualify if:
- Residing in the United States (residing in Alabama is not required)
- English as primary language
- Between 18+ years old
- Diagnosis of MS
- Relapse free in the past 30 days
- Internet and email access
- Currently physically inactive (GLTEQ)
- Able to ambulate without assistance (self-report and PDDS)
- Willingness to complete the questionnaires
- Willingness to wear the accelerometer
- Willingness to undergo random assignment (BIPAMS or WellMS)
You may not qualify if:
- Individuals with moderate to high risk for contraindications of possible injury or death when undertaking strenuous or maximal exercise (PARQ)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Related Publications (1)
Motl RW, Sandroff BM, Benedict RHB, Aldunate R, Cutter G, Barron E. Internet-delivered lifestyle physical activity intervention for cognitive processing speed in multiple sclerosis. Contemp Clin Trials. 2024 Mar;138:107446. doi: 10.1016/j.cct.2024.107446. Epub 2024 Jan 17.
PMID: 38242351DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert W Motl, PhD
University of Illinois at Chicago
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 10, 2020
First Posted
August 19, 2020
Study Start
March 1, 2023
Primary Completion (Estimated)
October 31, 2026
Study Completion (Estimated)
October 31, 2026
Last Updated
January 6, 2026
Record last verified: 2026-01