Project BIPAMS: Behavioral Intervention for Physical Activity in Multiple Sclerosis

NCT03490240 | Active Not Recruiting

• 1 other identifier: 170609001
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial will examine the effect of a 6-month behavioral intervention, based on social cognitive theory and delivered through the Internet, for increasing physical activity and secondarily improving mobility, cognition, symptoms and quality of life in persons with MS. The investigators hypothesize that individuals who receive the 6-month behavioral intervention will demonstrate an increase in physical activity behavior that will last throughout a 6-month follow up compared with participants in the control condition. The investigators further hypothesize that individuals in the behavioral intervention will demonstrate better walking mobility and cognitive function, reduced fatigue, depression, anxiety, and pain, and improved quality of life compared to the control condition. The investigators hypothesize that the behavioral intervention will increase physical activity through positive changes in self-efficacy, outcome expectations, goal setting, and impediments as social-cognitive determinants.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• Change of Physical Activity levels through Accelerometery from baseline at 6 and 12 months.

  Physical activity will be assessed using an ActiGraph accelerometer. Participants will wear an accelerometer on a belt around their waist during the waking hours of a 7 day period. Participants will complete this at baseline, 6 months, and 12 months.

  Baseline through 12 months

• Change of Physical Activity levels through the Godin Leisure-Time Exercise Questionnaire from baseline at 6 and 12 months.

  Physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire. Participants will complete this questionnaire at baseline, 6 months, and 12 months.

  Baseline through 12 months.

• Change of Physical Activity levels through the Abbreviated International Physical Activity Questionnaire from baseline at 6 and 12 months.

  Physical activity will be assessed using the Abbreviated International Physical Activity Questionnaire. Participants will complete this questionnaire at baseline, 6 months, and 12 months.

  Baseline through 12 months.

Secondary Outcomes (11)

• Change of self-report measures of walking through the Multiple Sclerosis Walking Scale - 12 from baseline at 6 and 12 months

  Baseline through 12 months

• Change of self-report measures of Walking through the Patient Determined Disease Steps Scale from baseline at 6 and 12 months.

  Baseline through 12 months

• Change of self-report measures of Cognition through the Perceived Deficits Questionnaire from baseline at 6 and 12 months.

  Baseline through 12 months

• Change of self-report measures of Cognition through the Multiple Sclerosis Neuropsychological Questionnaire from baseline at 6 and 12 months.

  Baseline through 12 months

• Change of self-report measures of Fatigue through the Fatigue Severity Scale from baseline at 6 and 12 months.

  Baseline through 12 months

Other Outcomes (6)

• Changes of self-report measures based on Social Cognitive Theory on Self-Efficacy through the MS Self-Efficacy Sale at 6 and 12 months from baseline.

  Baseline through 12 months

• Changes of self-report measures based on Social Cognitive Theory on Self-Efficacy through the Exercise Self-Efficacy Scale at 6 and 12 months from baseline.

  Baseline through 12 months

• Changes of self-report measures based on goal setting through the Exercise Goal Setting and Planning Scale at 6 and 12 months from baseline.

  Baseline through 12 months

Study Arms (2)

BIPAMS

EXPERIMENTAL

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.

Behavioral: BIPAMS

WELLMS

ACTIVE COMPARATOR

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.

Behavioral: WELLMS

Interventions

BIPAMS BEHAVIORAL

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.

BIPAMS

WELLMS BEHAVIORAL

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.

WELLMS

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of MS
• 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

You may not qualify if:

• Moderate or high risk for undertaking strenuous or maximal exercise per participants response to the PAR-Q. Those who report no more than one YES or affirmative on the 7 item PAR-Q will be considered at low risk and included for participation. All others will be considered at moderate or high risk and excluded from participation.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

Exercise Neuroscience Research Lab

Birmingham, Alabama, 35233, United States

Location

Related Publications (3)

• 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.

  PMID: 36843446 DERIVED

• 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.

  PMID: 36535606 DERIVED

• 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.

  PMID: 30821692 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Donald Lein, PhD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The investigators will advertise the study as comparing two approaches delivered through the Internet for managing consequences of MS and improving health indicators. On randomization, the investigators will again reaffirm this position with the participant. The participant will not be informed about which condition is the control or the intervention.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: April 6, 2018
• Study Start: March 1, 2018
• Primary Completion: March 1, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (1)