Preventive Program in Multiple Sclerosis

Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT04667130

What it found

No results found

We found no results in the registry or in papers.

This trial finished 7 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis

What it measured

Main measures

  • Questionnaires - The Fatigue scale for motor and cognitive functions

    change after six months of the program and after next six moths without therapy is being assessed

    Thinking and memoryFatigue

  • Questionnaires - The Satisfaction With Life Scale

    change after six months of the program and after next six moths without therapy is being assessed

    Quality of life (reported by participants)

  • Questionnaires - Multiple Sclerosis Acceptance Questionnaire

    change after six months of the program and after next six moths without therapy is being assessed

  • Questionnaires - Beck Depression Inventory Score

    change after six months of the program and after next six moths without therapy is being assessed

    Mood and sleep

Other measures (10)

  • Ventilation capacity

    change after six months of the program and after next six moths without therapy is being assessed

  • Metabolic utilization

    change after six months of the program and after next six moths without therapy is being assessed

  • Maximal oxygen uptake

    change after six months of the program and after next six moths without therapy is being assessed

    Physical function

  • Maximal oxygen pulse

    change after six months of the program and after next six moths without therapy is being assessed

    Physical function

  • Relative ventilation

    change after six months of the program and after next six moths without therapy is being assessed

  • Cortisol

    change after six months of the program and after next six moths without therapy is being assessed

  • Cortizone

    change after six months of the program and after next six moths without therapy is being assessed

  • Dehydroepiandrosterone (DHEA)

    change after six months of the program and after next six moths without therapy is being assessed

  • 7β-hydroxydehydroepiandrosterone (7β-OH-DHEA )

    change after six months of the program and after next six moths without therapy is being assessed

  • 7-oxo dehydroepiandrosterone (7-oxo-DHEA )

    change after six months of the program and after next six moths without therapy is being assessed

Who could take part

MS (type not specified) · 18 to 70

Show the full criteria

Inclusion criteria

* definite MS * stable clinical status in the preceding 3 months * imumnomodulatory treatment for at least two years (including glatiramer acetate, interferon beta-1a, 1b, mitoxantrone, fingolimod, natalizumab) * Expanded Disability Status Scale (EDSS)≤6 * predominant motor impartment * six months or more without any physiotherapy * ability to undergo ambulatory physiotherapy

Exclusion criteria

* other neurological disease or conditions disabling movement

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

About this trial

In the sponsor's words

This study monitor the immediate and persistent impact of a preventive complex six-month program specifically developed for newly diagnosed people with multiple sclerosis on fatigue, mental and physical fitness, and quality of life. The study determined whether changes in clinical function are related to changes in neurohormones, and whether the effect of therapy is dependent on the active approach of study participants.

Papers

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    History

      1. Started

        Oct 2017

      2. Main results due

        Oct 2019

      3. Finished

        Oct 2019

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