Phase-III, Randomized Controlled Trial of the Behavioral Intervention for Increasing Physical Activity in Multiple Sclerosis: Project BIPAMS

Authors

Robert W. Motl, University of Alabama, Birmingham
Brian M. Sandroff, University of Alabama - Birmingham
Brooks C. Wingo, University of Alabama - Birmingham
Justin McCroskey, University of Alabama - Birmingham
Lara A. Pilutti, University of Ottawa
Gary R. Cutter, University of Alabama - Birmingham
Rachel Bollaert, Marquette UniversityFollow
Edward McAuley, University of Illinois

Document Type

Article

Language

eng

Publication Date

8-2018

Publisher

Elsevier

Source Publication

Contemporary Clinical Trials

Source ISSN

1551-7144

Original Item ID

DOI: 10.1016/j.cct.2018.06.017

Abstract

Background

We propose a phase-III, randomized controlled trial (RCT) that examines the effectiveness of a behavioral intervention based on social cognitive theory (SCT) and delivered through the Internet using e-learning approaches for increasing physical activity and secondary outcomes (e.g., symptoms) in a large sample of people with multiple sclerosis (MS) residing throughout the United States.

Methods/design

The proposed phase-III trial will use a parallel group, RCT design that examines the effect of a 6-month behavioral intervention for increasing physical activity and secondarily improving mobility, cognition, symptoms, and quality of life (QOL) in persons with MS. The primary outcome is accelerometer-measured moderate-to-vigorous physical activity (MVPA). The secondary outcomes include self-report measures of physical activity, walking impairment, cognition, fatigue, depression, anxiety, pain, sleep quality, and QOL. The tertiary outcomes are mediator variables based on SCT. Participants (N = 280) will be randomized into behavioral intervention (n = 140) or attention and social contact control (n = 140) conditions using computerized random numbers with concealed allocation. The conditions will be administered over 6-months by persons who are uninvolved in screening, recruitment, random assignment, and outcome assessment. There will be a 6-month follow-up without intervention access/content. We will collect primary, secondary, and tertiary outcome data every 6 months over the 12-month period. Data analysis will involve intent-to-treat principles and latent growth modeling (LGM).

Discussion

The proposed research will provide evidence for the effectiveness of a novel, widely scalable approach for increasing lifestyle physical activity and improving secondary outcomes and QOL in persons with MS.

Comments

Accepted version. Contemporary Clinical Trials, Vol. 71 (August 2018): 154-161. DOI. © 2018 Elsevier. Used with permission.

Rachel E. Bollaert was affiliated with University of Illinois at Urbana-Champaign at the time of publication.

Recommended Citation

Motl, Robert W.; Sandroff, Brian M.; Wingo, Brooks C.; McCroskey, Justin; Pilutti, Lara A.; Cutter, Gary R.; Bollaert, Rachel; and McAuley, Edward, "Phase-III, Randomized Controlled Trial of the Behavioral Intervention for Increasing Physical Activity in Multiple Sclerosis: Project BIPAMS" (2018). Exercise Science Faculty Research and Publications. 160.
https://epublications.marquette.edu/exsci_fac/160