Exercise in Multiple Sclerosis: Effects on Cognitive Function and Brain Connectivity
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Cognitive dysfunction is frequent in patients with multiple sclerosis (MS) and to date, there
      are no available treatments to improve cognition in this patient population. Some evidence
      from animal studies and small clinical trials suggest that aerobic exercise might
      beneficially affect cognitive function in MS. The aim of this randomized-controlled trial is
      to explore if an aerobic exercise training program can enhance cognition in MS. In addition,
      we will employ neuroimaging markers to determine if exercise alters measures of brain
      structure and function.

      Patients will be randomly assigned to either a 3-months exercise program (bicycle ergometry,
      2-3 session per week) or a waitlist control group. The primary endpoint of the study is a
      test of verbal learning and memory. Secondary endpoints include neuroimaging markers of
      functional and structural connectivity in the brain. We hypothesize that exercise will
      improve verbal learning and memory and beneficially affect measures of brain connectivity.
    

Detailed description: 
      Background: Cognitive dysfunction is frequent in patients with multiple sclerosis (MS) and to
      date, there are no available treatments to improve cognition in this patient population. Some
      evidence from animal studies and small clinical trials suggest that aerobic exercise might
      beneficially affect cognitive function in MS.

      Aims: This study aims to explore the potential of an aerobic exercise program on brain
      structure and function in MS in a single-blind, randomized controlled phase IIa trial. We
      hypothesize that exercise will improve verbal learning and memory (primary endpoint) as well
      as induce changes in neuroimaging markers of structural and functional central nervous system
      (CNS) connectivity (secondary endpoints). Tertiary outcomes will include walking ability,
      motor function and coordination, as well as patient-based outcomes (depression, fatigue, and
      health-related quality of life).

      Design: This is a single-blind, randomized, controlled phase IIa trial with a parallel group
      design comparing 3 months of standardized aerobic exercise training (bicycle ergometry) to a
      waitlist control group (superiority framework). The allocation ratio of exercise to waitlist
      control is 1:1 with a sample size of n=60.
    

Intervention name(s): Aerobic Exercise
Intervention type(s): Behavioral
Intervention description(s): 3-months exercise program tailored to the individual level of aerobic fitness. Patients will exercise on a bicycle ergometer (2-3 session per week) according to a predefined training plan with increasing duration and intensity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise; Cognition; Neuroimaging; Rehabilitation; Connectivity