Project BIPAMS: Behavioral Intervention for Physical Activity in Multiple Sclerosis
NCT ID: NCT03490240
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
280 participants
INTERVENTIONAL
2018-03-01
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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BIPAMS
The behavioral intervention consists of two primary components, a dedicated Internet website and one-on-one video chats with a behavioral coach via Skype. The behavioral intervention focuses on the skills, techniques, resources, and strategies for becoming and staying physically active with MS, but it does not provide a prescription for exercise or physical activity itself.
BIPAMS
The primary content of the website is delivered through interactive video courses. The interactive video courses are released seven times during the first two months, four times during the second two months, and twice during the final two months of the intervention.
Another key part of the website is the Tracker feature. This feature allows for tracking of daily step counts (via Yamax SW-200 pedometer) as well as setting goals and monitoring progress over the program.
The one-on-one video chats are conducted face to face through skype and are semi-scripted. The chats consist of an ongoing review of goal-setting and progress toward goal attainment through Tracker as well as discussion of strategies and facilitators of behavioral change based on SCT and current website content. The chats occur seven times during the first two months, four times during the second two months, and twice during the final two months of the intervention.
WELLMS
The control condition provides an Internet website and one-on-one video chats that discuss materials about self-managing MS consequences and health indicators through methods other than physical activity.
WELLMS
The control condition focuses on self-managing MS through means other than physical activity. The materials are transformations of brochures provided by the NMSS, 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 account for attention and social contact as well as other possible biases such as initial reactivity and time spent on the website and video chats. The participants in the control condition will not be offered the behavioral intervention for increasing physical activity after completion of the study procedures.
Interventions
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BIPAMS
The primary content of the website is delivered through interactive video courses. The interactive video courses are released seven times during the first two months, four times during the second two months, and twice during the final two months of the intervention.
Another key part of the website is the Tracker feature. This feature allows for tracking of daily step counts (via Yamax SW-200 pedometer) as well as setting goals and monitoring progress over the program.
The one-on-one video chats are conducted face to face through skype and are semi-scripted. The chats consist of an ongoing review of goal-setting and progress toward goal attainment through Tracker as well as discussion of strategies and facilitators of behavioral change based on SCT and current website content. The chats occur seven times during the first two months, four times during the second two months, and twice during the final two months of the intervention.
WELLMS
The control condition focuses on self-managing MS through means other than physical activity. The materials are transformations of brochures provided by the NMSS, 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 account for attention and social contact as well as other possible biases such as initial reactivity and time spent on the website and video chats. The participants in the control condition will not be offered the behavioral intervention for increasing physical activity after completion of the study procedures.
Eligibility Criteria
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Inclusion Criteria
* Relapse free in the past 30 days
* Internet and email access
* Willingness to complete the questionnaires, wear the accelerometer, and undergo randomization
* Being non-active defined as not engaging in regular activity (30 minutes accumulated per day) on more than 2 days of the week during the previous six months
* Ability to ambulate with or without assistance (i.e. walking with or without a can or walker, but not a wheelchair)
* Age between 18 and 64
Exclusion Criteria
18 Years
64 Years
ALL
No
Sponsors
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National Multiple Sclerosis Society
OTHER
University of Alabama at Birmingham
OTHER
Responsible Party
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Donald Lein
Primary Investigator
Principal Investigators
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Donald Lein, PhD
Role: PRINCIPAL_INVESTIGATOR
Associate Professor
Locations
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Exercise Neuroscience Research Lab
Birmingham, Alabama, United States
Countries
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References
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Motl RW, Kidwell-Chandler A, Sandroff BM, Pilutti LA, Cutter GR, Aldunate R, Bollaert RE. Primary results of a phase-III, randomized controlled trial of the Behavioral Intervention for increasing Physical Activity in Multiple Sclerosis project. Mult Scler. 2023 Mar;29(3):415-426. doi: 10.1177/13524585221146430.
Motl RW, Sandroff BM, Pilutti LA, Cutter GR, Aldunate R, Kidwell-Chandler A, Bollaert RE. Randomized controlled trial of the behavioral intervention for increasing physical activity in multiple sclerosis project: Secondary, patient-reported outcomes. Contemp Clin Trials. 2023 Feb;125:107056. doi: 10.1016/j.cct.2022.107056. Epub 2022 Dec 16.
Silveira SL, McCroskey J, Wingo BC, Motl RW. eHealth-Based Behavioral Intervention for Increasing Physical Activity in Persons With Multiple Sclerosis: Fidelity Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Mar 1;8(3):e12319. doi: 10.2196/12319.
Other Identifiers
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170609001
Identifier Type: -
Identifier Source: org_study_id