Phase-III, randomized controlled trial of the behavioral intervention for increasing physical activity in multiple sclerosis: Project BIPAMS

Robert W Motl; Brian M Sandroff; Brooks C Wingo; Justin McCroskey; Lara A Pilutti; Gary R Cutter; Rachel E Bollaert; Edward McAuley

doi:10.1016/j.cct.2018.06.017

Phase-III, randomized controlled trial of the behavioral intervention for increasing physical activity in multiple sclerosis: Project BIPAMS

Contemp Clin Trials. 2018 Aug:71:154-161. doi: 10.1016/j.cct.2018.06.017. Epub 2018 Jun 27.

Authors

Robert W Motl¹, Brian M Sandroff², Brooks C Wingo³, Justin McCroskey², Lara A Pilutti⁴, Gary R Cutter⁵, Rachel E Bollaert⁶, Edward McAuley⁶

Affiliations

¹ Department of Physical Therapy, University of Alabama at Birmingham, USA. Electronic address: robmotl@uab.edu.
² Department of Physical Therapy, University of Alabama at Birmingham, USA.
³ Department of Occupational Therapy, University of Alabama at Birmingham, USA.
⁴ Interdisciplinary School of Health Sciences, University of Ottawa, Canada.
⁵ Department of Biostatistics, University of Alabama at Birmingham, USA.
⁶ Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, USA.

PMID: 29959105
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.

Keywords: Behavior change; E-learning; Multiple sclerosis; Physical activity; Theory.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Accelerometry / methods
Adult
Behavior Therapy* / methods
Clinical Trials, Phase III as Topic
Cognition
Exercise Therapy / methods
Exercise Therapy / psychology
Exercise* / physiology
Exercise* / psychology
Female
Humans
Internet
Life Style*
Male
Multiple Sclerosis* / diagnosis
Multiple Sclerosis* / physiopathology
Multiple Sclerosis* / psychology
Multiple Sclerosis* / therapy
Outcome Assessment, Health Care
Quality of Life*
Randomized Controlled Trials as Topic
Self Report
Telemedicine* / methods