Internet-Delivered Lifestyle Physical Activity Intervention for Cognitive Processing Speed in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— BIPAMS-Cog  

Official title:

Internet-Delivered Lifestyle Physical Activity Intervention for Cognitive Processing Speed in Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04518657
• Other study ID #: 2022-0084
• Secondary ID: 1R01HD103812
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: May 2024
• Source: University of Illinois at Chicago
• Contact: Robert W Motl, Ph.D
• Phone: 312 413-7850
• Email: robmotl[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: July 31, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Accelerometry	Device-based measure of physical activity and sedentary behavior (ActiGraph)	Changes in accelerometry data from Baseline, 6-Month, and 12-Month
Primary	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	Fatigue Severity	Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity.	Changes in fatigue from Baseline, 6-Months, and 12-Months
Secondary	Fatigue Impact	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.	Changes in fatigue from Baseline, 6-Months, and 12-Months
Secondary	Depressive Symptoms	Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms.	Changes in depressive symptoms from Baseline, 6-Month, and 12-Month
Secondary	Anxiety	Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms.	Changes in anxiety symptoms from Baseline, 6-Month, and 12-Month
Secondary	Quality of Life (QOL)	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).	Changes in quality of life from Baseline, 6-Month, and 12-Month