Internet-Delivered Lifestyle Physical Activity Intervention for Cognitive Processing Speed in Multiple Sclerosis (BIPAMS-Cog)

• ClinicalTrials.gov Identifier: NCT04518657
• Recruitment Status: Recruiting
• First Posted: August 19, 2020
• Last Update Posted: April 6, 2023
• Sponsor: University of Illinois at Chicago
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): Robert W Motl, University of Illinois at Chicago

Tracking Information

• First Submitted Date: August 10, 2020
• First Posted Date: August 19, 2020
• Last Update Posted Date: April 6, 2023
• Actual Study Start Date: March 1, 2023
• Estimated Primary Completion Date: October 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 14, 2020)

Cognition [ Time Frame: Changes in cognition scores from Baseline, 6-Month, and 12-Month ]

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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 19, 2021)

• Fatigue Severity [ Time Frame: Changes in fatigue from Baseline, 6-Months, and 12-Months ]
  Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity.
• Fatigue Impact [ Time Frame: Changes in fatigue from Baseline, 6-Months, and 12-Months ]
  Modified Fatigue Impact Scale (MFIS); scores range between 0 (min) and 84 (max), higher scores indicate greater impact of fatigue on a patient's activities.
• Depressive Symptoms [ Time Frame: Changes in depressive symptoms from Baseline, 6-Month, and 12-Month ]
  Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms.
• Anxiety [ Time Frame: Changes in anxiety symptoms from Baseline, 6-Month, and 12-Month ]
  Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms.
• Quality of Life (QOL) [ Time Frame: Changes in quality of life from Baseline, 6-Month, and 12-Month ]
  Multiple Sclerosis Impact Scale (MSIS-29); scores range between 0 (min) and 100 (max), higher scores indicate greater impact of disease on daily function (i.e. worse outcomes).

Original Secondary Outcome Measures (submitted: August 14, 2020)

• Fatigue [ Time Frame: Changes in fatigue from Baseline, 6-Months, and 12-Months ]
  Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity.
• Fatigue [ Time Frame: Changes in fatigue from Baseline, 6-Months, and 12-Months ]
  Modified Fatigue Impact Scale (MFIS); scores range between 0 (min) and 84 (max), higher scores indicate greater impact of fatigue on a patient's activities.
• Depressive Symptoms [ Time Frame: Changes in depressive symptoms from Baseline, 6-Month, and 12-Month ]
  Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms.
• Anxiety [ Time Frame: Changes in anxiety symptoms from Baseline, 6-Month, and 12-Month ]
  Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms.
• Quality of Life (QOL) [ Time Frame: Changes in quality of life from Baseline, 6-Month, and 12-Month ]
  Multiple Sclerosis Impact Scale (MSIS-29); scores range between 0 (min) and 100 (max), higher scores indicate greater impact of disease on daily function (i.e. worse outcomes).

Current Other Pre-specified Outcome Measures (submitted: August 14, 2020)

Accelerometry [ Time Frame: Changes in accelerometry data from Baseline, 6-Month, and 12-Month ]

Device-based measure of physical activity and sedentary behavior (ActiGraph)

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Internet-Delivered Lifestyle Physical Activity Intervention for Cognitive Processing Speed in Multiple Sclerosis
• Official Title: Internet-Delivered Lifestyle Physical Activity Intervention for Cognitive Processing Speed in Multiple Sclerosis
• 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.
• Detailed Description: Cognitive impairment is prevalent, disabling, and poorly-managed among the 1 million Americans living with multiple sclerosis (MS). Indeed, 67% of adults with MS have cognitive impairment, particularly slowed cognitive processing speed (CPS), and this is associated with impaired learning and memory and worse fatigue, depression, anxiety, pain, and quality of life (QOL). This underscores the importance of identifying efficacious approaches for managing CPS impairment and its consequences among those with MS. There is merit in a remotely-delivered physical activity (PA) intervention for managing MS-related CPS dysfunction in MS. We have provided evidence from a pilot, randomized controlled trial (RCT) that an Internet-delivered PA intervention resulted in a clinically meaningful improvement in CPS among those with mild MS-related ambulatory disability; there were additional improvements in fatigue, depression, anxiety, pain, and QOL. The pilot RCT did not a priori recruit persons with MS who had objective CPS impairment nor examine sustainability of CPS changes over time, and it involved a waitlist control that did not account for the effects of attention and social contact. We leverage our experiences and preliminary results, and propose an appropriately-powered, Phase-II, RCT of a highly-developed and refined Internet-delivered PA intervention focusing on walking during ambulatory activities of daily living (steps/day) for yielding immediate and sustained improvements in remotely-assessed CPS among persons with mild MS-related ambulatory disability who demonstrate impaired CPS. The proposed study, if successful, will provide Class I evidence regarding the efficacy of a 6-month, Internet-delivered, PA intervention compared with an active control condition for improving important outcomes in 300 adults with MS who present with both mild MS ambulatory disability and impaired CPS. The primary outcome is the remotely-delivered Symbol Digit Modalities Test as a measure of CPS; the secondary outcomes include a remotely-delivered, objective measure of learning and memory and self-reports of fatigue, depression, anxiety, pain, and QOL; the tertiary outcome is accelerometry as an objective, device-based measure of PA. The conditions will be delivered by persons who are uninvolved in screening, recruitment, random assignment, and outcome assessment. We will collect outcomes on 3 occasions over a 12-month period (i.e., pre-intervention, immediately post-intervention, and 6-month follow-up). The outcomes will be collected using a blinded assessor. Data analyses will involve intent-to-treat principles, and mixed-effects models and logistic regression. The proposed research may yield "real-world" guidelines for free-living PA change that can be implemented for the treatment of CPS impairment in MS. Such an opportunity for rehabilitation of cognitive function using an approach with broad reach and scalability is paramount considering the prevalent, disabling, and poorly-managed nature of CPS impairment in MS and limited resources for its treatment.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Multiple Sclerosis

Intervention

• Behavioral: Behavioral Intervention for Physical Activity in MS (BIPAMS)
  A behavioral intervention that involves an internet website and one-on-one video coaching calls for increasing physical activity in people with MS.
• Behavioral: Wellness for MS (WellMS)
  A behavioral intervention that involves an internet website and one-on-one video coaching calls for increasing wellness in people with MS.

Study Arms

• Experimental: Behavioral Intervention for Physical Activity in MS (BIPAMS)
  The 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.
  Intervention: Behavioral: Behavioral Intervention for Physical Activity in MS (BIPAMS)
• Sham Comparator: Wellness for MS (WellMS)
  Provides 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.
  Intervention: Behavioral: Wellness for MS (WellMS)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 14, 2020): 280
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 31, 2025
• Estimated Primary Completion Date: October 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Individuals not meeting above inclusion criteria
• Individuals with moderate to high risk for contraindications of possible injury or death when undertaking strenuous or maximal exercise (PARQ)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Robert W Motl, Ph.D; 312 413-7850; robmotl@uic.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04518657
• Other Study ID Numbers: 2022-0084; 1R01HD103812 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Robert W Motl, University of Illinois at Chicago
• Original Responsible Party: Robert W Motl, University of Alabama at Birmingham, Professor
• Current Study Sponsor: University of Illinois at Chicago
• Original Study Sponsor: University of Alabama at Birmingham
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Principal Investigator: Robert W Motl, PhD; University of Illinois at Chicago

• PRS Account: University of Illinois at Chicago
• Verification Date: April 2023