Internet-Delivered Lifestyle Physical Activity Intervention for Cognitive Processing Speed in Multiple Sclerosis (BIPAMS-Cog)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04518657|
Recruitment Status : Recruiting
First Posted : August 19, 2020
Last Update Posted : April 6, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Behavioral: Behavioral Intervention for Physical Activity in MS (BIPAMS) Behavioral: Wellness for MS (WellMS)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||280 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Internet-Delivered Lifestyle Physical Activity Intervention for Cognitive Processing Speed in Multiple Sclerosis|
|Actual Study Start Date :||March 1, 2023|
|Estimated Primary Completion Date :||October 31, 2024|
|Estimated Study Completion Date :||July 31, 2025|
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.
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.
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.
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.
- 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.
- 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).
- Accelerometry [ Time Frame: Changes in accelerometry data from Baseline, 6-Month, and 12-Month ]Device-based measure of physical activity and sedentary behavior (ActiGraph)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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)
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04518657
|Contact: Robert W Motl, Ph.D||312 email@example.com|
|United States, Illinois|
|University of Illinois at Chicago||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Robert W Motl, PhD 312-413-7850 firstname.lastname@example.org|
|Principal Investigator:||Robert W Motl, PhD||University of Illinois at Chicago|
|Responsible Party:||Robert W Motl, Professor, University of Illinois at Chicago|
|Other Study ID Numbers:||
1R01HD103812 ( U.S. NIH Grant/Contract )
|First Posted:||August 19, 2020 Key Record Dates|
|Last Update Posted:||April 6, 2023|
|Last Verified:||April 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Immune System Diseases