The Impact of Structured Exercise on Physical Fitness, Sedentary Time, Brain Volume, Cognitive, Health-related and Immunological Parameters in Multiple Sclerosis.

CompletedNot a drug-phase studyMS (type not specified)NCT04191772

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Periodized, home-based running program

What it measured

Main measures

  • Number of steps per day

    Before start of the training program

    Physical function
  • Number of steps per day

    Week 1 of the training program

    Physical function
  • Number of steps per day

    Week 24 of the training program

    Physical function
  • Number of steps per day

    Week 48 of the training program

    Physical function
  • Number of steps per day

    3 months after the training program

    Physical function
  • Sitting time

    Before start of the training program

    Physical function
  • Sitting time

    Week 1 of the training program

    Physical function
  • Sitting time

    Week 24 of the training program

    Physical function
  • Sitting time

    Week 48 of the training program

    Physical function
  • Sitting time

    3 months after the training program

    Physical function
  • Standing time

    Before start of the training program

    Physical function
  • Standing time

    Week 1 of the training program

    Physical function
  • Standing time

    Week 24 of the training program

    Physical function
  • Standing time

    Week 48 of the training program

    Physical function
  • Standing time

    3 months after the training program

    Physical function
  • Stepping time

    Before start of the training program

    Physical function
  • Stepping time

    Week 1 of the training program

    Physical function
  • Stepping time

    Week 24 of the training program

    Physical function
  • Stepping time

    Week 48 of the training program

    Physical function
  • Stepping time

    3 months after the training program

    Physical function

Other measures (62)

  • Blood pressure

    Baseline

  • Blood pressure

    Week 48 of the training program

  • Resting heart rate

    Baseline

  • Resting heart rate

    Week 48 of the training program

  • Total calorie intake

    Baseline

  • Total calorie intake

    Week 12 of the training program

  • Total calorie intake

    Week 24 of the training program

  • Total calorie intake

    Week 48 of the training program

  • Total calorie intake

    3 months after the training program

  • Macronutrient content

    Baseline

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* Multiple Sclerosis according to the McDonald criteria (Relaps remitting) * Written informed consent * Medical safety screening

Exclusion criteria

* Contra-indications to participate in moderate to high intensity exercise * Contra-indications to undergo magnetic resonance imaging (pacemaker/defibrillator or wires other than sternal wires, insulin pumps, metal foreign bodies, deep brain stimulator, cerebral aneurysm clips, cochlear implant, magnetic dental implant, drug infusion device) * Medication changes in the last month before the start of the intervention * Following or plan to follow a weight reduction program * Pregnancy * Participation in another study * Acute MS exacerbation \< 3 months prior to the start of the study * EDSS score > 4 * Consumption of more than 20 alcohol units/week * No daily internet access

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The current study aims to investigate whether persons with Multiple Sclerosis (PwMS) compensate training time with more sedentary time and consequently blunt training effects. The second aim will be to investigate the effect of a structured training program on specific brain volumes and cognitive variables.

Papers

Loading reviews and guidelines…

History

    1. Started

      Jan 2020

    2. Main results due

      Jun 2021

    3. Finished

      Jun 2021

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