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Phase-III, randomized controlled trial of the behavioral intervention for increasing physical activity in multiple sclerosis: Project BIPAMS.
Motl, Robert W; Sandroff, Brian M; Wingo, Brooks C; McCroskey, Justin; Pilutti, Lara A; Cutter, Gary R; Bollaert, Rachel E; McAuley, Edward.
Afiliación
  • Motl RW; Department of Physical Therapy, University of Alabama at Birmingham, USA. Electronic address: robmotl@uab.edu.
  • Sandroff BM; Department of Physical Therapy, University of Alabama at Birmingham, USA.
  • Wingo BC; Department of Occupational Therapy, University of Alabama at Birmingham, USA.
  • McCroskey J; Department of Physical Therapy, University of Alabama at Birmingham, USA.
  • Pilutti LA; Interdisciplinary School of Health Sciences, University of Ottawa, Canada.
  • Cutter GR; Department of Biostatistics, University of Alabama at Birmingham, USA.
  • Bollaert RE; Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, USA.
  • McAuley E; Department of Kinesiology and Community Health, University of Illinois at Urbana-Champaign, USA.
Contemp Clin Trials ; 71: 154-161, 2018 08.
Article en En | MEDLINE | ID: mdl-29959105
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Calidad de Vida / Terapia Conductista / Ejercicio Físico / Telemedicina / Estilo de Vida / Esclerosis Múltiple Tipo de estudio: Clinical_trials / Diagnostic_studies / Prognostic_studies Aspecto: Patient_preference Límite: Adult / Female / Humans / Male Idioma: En Revista: Contemp Clin Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2018 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
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XML
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Calidad de Vida / Terapia Conductista / Ejercicio Físico / Telemedicina / Estilo de Vida / Esclerosis Múltiple Tipo de estudio: Clinical_trials / Diagnostic_studies / Prognostic_studies Aspecto: Patient_preference Límite: Adult / Female / Humans / Male Idioma: En Revista: Contemp Clin Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2018 Tipo del documento: Article Pais de publicación: Estados Unidos