A Task-oriented Circuit Training in Multiple Sclerosis

A Task-oriented Circuit Training in Multiple Sclerosis: a Multicentric Randomized Controlled Trial

CompletedNot a drug-phase studyMS (type not specified)NCT02421744

What it found

No results found

We found no results in the registry or in papers.

This trial finished 8 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Task Oriented Circuit Training

Compared with

  • Delayed Onset TOCT

What it measured

Main measures

  • Six-Minute Walking Test

    Weeks: 0,2,14, 26

    Walking and mobility

Other measures (13)

  • Timed 25-Foot walk (25FWT)

    weeks: 0,2,14, 26

    Disability progressionWalking and mobility

  • Time Up and Go Test

    weeks: 0,2,14, 26

    Walking and mobility

  • Dynamic Gait Index (DGI)

    weeks: 0,2,14, 26

    Walking and mobility

  • Modified fatigue impact scale (MFIS)

    weeks: 0,2,14, 26

    Thinking and memoryFatigue

  • Multiple Sclerosis Walking Scale - 12 (MSWS-12)

    weeks: 0,2,14, 26

    Walking and mobility

  • Multiple Sclerosis Impact Scale- 29 (MSIS-29)

    weeks: 0,2,14, 26

    Physical functionQuality of life (reported by participants)

  • Functional Assessment of Multiple Sclerosis (FAMS)

    weeks: 0,2,14, 26

    Quality of life (reported by participants)

  • Metabolic cerebral measurements by Near infrared spectroscopy

    weeks: 0,2,14, 26

    Walking and mobility

  • Postural sway (Center of pressure (COP) trajectories)

    weeks: 0,2,14, 26

  • Force and EMG signal (perform an isometric extension of the knees on an isokinetic dynamometer (PrimusRS BTETM Technology), achieving their own Maximum Voluntary Contraction (MVC)

    weeks: 0,2,14, 26

    Physical function

Who could take part

MS (type not specified) · 18 to 75 · EDSS 4 to 5

Show the full criteria

Inclusion criteria

* males and females, * community dwelling, * age >18 and \<75 * diagnosis of multiple sclerosis in a stable phase, with relapses > 3 months prior to study enrollment * moderate gait impairments referred to Expanded Disability Status Scale (EDSS) between 4 and 5,5 * MMSE >24

Exclusion criteria

* neurologic conditions in addition to multiple sclerosis that may affect motor function * medical conditions likely to interfere with the ability to safely complete the study * pregnancy

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

About this trial

In the sponsor's words

Our primary hypothesis is that a two weeks high-intensity task-oriented circuit training followed by a structured 3 months home exercise program would have higher benefits compared to a delayed-treatment group as control in people with multiple sclerosis and mild to moderate gait impairment. Our secondary hypothesis is that there could be retention of clinical gains in subjects that underwent TOCT plus structured 3 months home exercise program.

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History

    1. Started

      Mar 2015

    2. Main results due

      Oct 2018

    3. Finished

      Oct 2018

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