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NCT04518657 · ClinicalTrials.gov registry record · NA
Internet-Delivered Lifestyle Physical Activity Intervention for Cognitive Processing Speed in Multiple Sclerosis
A NA study of Multiple Sclerosis, sponsored by University of Illinois at Chicago.
- Recruiting
- Registry status
- NA
- Development phase
- 280
- Enrollment target
- 1
- Study location
NCT04518657 is a NA study of Multiple Sclerosis that is actively recruiting participants, run by University of Illinois at Chicago. The registered enrollment target is 280 participants, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (52% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04518657, a NA study of Multiple Sclerosis, is actively recruiting participants, sponsored by University of Illinois at Chicago.
- RECRUITING
- Registry status
- NA
- Development phase
- 280 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- BEHAVIORAL Behavioral Intervention for Physical Activity in MS (BIPAMS)
- BEHAVIORAL Wellness for MS (WellMS)
Study Locations (1)
Illinois
- University of Illinois at Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2023-03-01 |
| Est. Completion | 2026-10-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04518657
The ClinicalTrials.gov registry entry for NCT04518657 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 280 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 584-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (52% lower). The listed sponsor is University of Illinois at Chicago, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Behavioral Intervention for Physical Activity in MS (BIPAMS) is the first listed.
NCT04518657 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT04518657 about?
NCT04518657 is a clinical study titled "Internet-Delivered Lifestyle Physical Activity Intervention for Cognitive Processing Speed in Multiple Sclerosis". 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 ...
What is the current status of trial NCT04518657?
This trial is currently recruiting. It is a NA study. The enrollment target is 280 participants. The study started on 2023-03-01. Estimated completion is 2026-10-31.
What conditions does trial NCT04518657 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT04518657?
The interventions under investigation include: Behavioral Intervention for Physical Activity in MS (BIPAMS) (BEHAVIORAL), Wellness for MS (WellMS) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04518657?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04518657 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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