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Rationale and methodology for examining the combination of aerobic exercise and cognitive rehabilitation on new learning and memory in persons with multiple sclerosis and mobility disability: Protocol for a randomized controlled trial.
Wender, Carly L A; Arbelaez, Odalys; Tong, Tien T; Salter, Amber; Wylie, Glenn R; Motl, Robert W; Sandroff, Brian M; Chiaravalloti, Nancy D.
Afiliación
  • Wender CLA; Center for Neuropsychology & Neuroscience Research, Kessler Foundation, East Hanover, NJ, USA; Department of Physical Medicine and Rehabilitation, Rutgers-NJ Medical School, Newark, NJ, USA. Electronic address: cwender@kesslerfoundation.org.
  • Arbelaez O; Center for Neuropsychology & Neuroscience Research, Kessler Foundation, East Hanover, NJ, USA.
  • Tong TT; Center for Neuropsychology & Neuroscience Research, Kessler Foundation, East Hanover, NJ, USA.
  • Salter A; Department of Neurology, University of Texas Southwestern, Dallas, TX, USA.
  • Wylie GR; Center for Neuropsychology & Neuroscience Research, Kessler Foundation, East Hanover, NJ, USA; Department of Physical Medicine and Rehabilitation, Rutgers-NJ Medical School, Newark, NJ, USA.
  • Motl RW; Department of Kinesiology and Nutrition, University of Illinois Chicago, Chicago, IL, USA.
  • Sandroff BM; Center for Neuropsychology & Neuroscience Research, Kessler Foundation, East Hanover, NJ, USA; Department of Physical Medicine and Rehabilitation, Rutgers-NJ Medical School, Newark, NJ, USA.
  • Chiaravalloti ND; Center for Neuropsychology & Neuroscience Research, Kessler Foundation, East Hanover, NJ, USA; Department of Physical Medicine and Rehabilitation, Rutgers-NJ Medical School, Newark, NJ, USA.
Contemp Clin Trials ; 144: 107630, 2024 Sep.
Article en En | MEDLINE | ID: mdl-39002892
ABSTRACT

BACKGROUND:

This paper describes the protocol for a Phase I/II, parallel-group, single-blind randomized controlled trial (RCT). The RCT investigates the combined effects of 12-weeks of aerobic exercise training (AET) integrated with virtual reality (VR) and cognitive rehabilitation (CR) on new learning and memory in 78 persons with multiple sclerosis (MS) who have mobility disability and objective impairments in learning and memory.

METHODS:

Participants will undergo baseline assessments consisting of neuropsychological testing, neuroimaging, self-report questionnaires, and cardiorespiratory fitness. Participants will then be randomized into one of two conditions using concealed allocation aerobic cycling exercise that incorporates VR combined with CR or stretching and toning (i.e., active control; S/T) combined with CR. Participants will be masked regarding the intent of the conditions. After 7-weeks of exercise alone, the 5-week Kessler Foundation modified Story Memory Technique (KF-mSMT®) will be integrated into the training. After the 12-week training period, participants will complete the same measures as at baseline administered by treatment-blinded assessors. Primary study outcomes include new learning and memory (NLM) measured by a small battery of neuropsychological assessments that assess list learning (California Verbal Learning Test-II), prose memory (Memory Assessment Scale), visuospatial memory (Brief Visuospatial Memory Test-Revised), and everyday memory (Ecological Memory Simulations). Secondary study outcomes include neuroimaging outcomes of hippocampal structure, function, and connectivity.

CONCLUSION:

If successful, this trial will provide the first Class I evidence supporting the unique combination of aerobic cycling exercise with VR and CR for treating MS-related learning and memory impairments in persons with mobility disability.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Esclerosis Múltiple Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Contemp Clin Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Esclerosis Múltiple Límite: Adult / Female / Humans / Male / Middle aged Idioma: En Revista: Contemp Clin Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos