In Clinic Physical Activity in Persons With Multiple Sclerosis

Increasing Physical Activity in Recovered Persons With Multiple Sclerosis Through Daily Sensor Based Feedback and Weekly Focus Group Meetings: A Feasibility and Pilot II Study

Status unknownNot a drug-phase studyMS (type not specified)NCT04186910

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Feedback group

Placebo

  • Control group

What it measured

Main measures

  • Number of passes with Fitbit wristband

    Change from number of passes at baseline to number of passes after 4 weeks will be measured.

    Thinking and memoryWalking and mobility

  • The 2 minute walking test

    Change on the measue will be measured. Will be applied at Day 1 and after 4 weeks

    Walking and mobility

  • The Self-Efficacy in Multiple Sclerosis Scale

    Change on the measure will be measured. Will be applied at Day 1, after 4 weeks and after 10 weeks

Other measures (6)

  • The 10 meters walking scale

    Change from Day 1 to day 28 will be measured. Will be applied at the Day 1 and after 4 weeks

    Walking and mobility

  • The Short Form-12 questionnaire

    Change from Day 1 to 4 weeks and until 10 weeks will be measured. Will be applied at baseline Day 1 after 4 weeks and after 10 weeks

  • The EQ-5D visual analogue scale

    Change from Day 1 to 4 weeks and until 10 weeks will be measured. Will be applied at the Day 1, after 4 weeks and after 10 weeks

    Quality of life (reported by participants)

  • The Twelve Item MS Walking Scale

    Change from Day 1 to 4 weeks and until 10 weeks will be measured. Will be applied at the Day 1, after 4 weeks and after 10 weeks

    Walking and mobility

  • The Fatigue severity Scale

    Change from Day 1 to 4 weeks and until 10 weeks will be measured. Will be applied at the Day 1, after 4 weeks and after 10 weeks

    Fatigue

  • The Physical Activity Disability Survey-Revised questionnaire

    Change from Day 1 to 4 weeks and until 10 weeks will be measured. Will be applied at the Day 1, after 4 weeks and after 10 weeks

    Physical function

Who could take part

MS (type not specified) · 18 to 70 · EDSS 4.5 to 7

Show the full criteria

Inclusion criteria

* Diagnosis of MS according to the McDonald's criteria McDonald Criteria 2010 * EDSS score >4.5-7 * Freedom from relapses and steroid treatment for at least 1 month * Ability to walk at least 10 meters independently with or without support * MS without relapses in the last 3 months

Exclusion criteria

* Mini Mental State Examination (MMSE) score \< 20 * The presence of disabling pain or severe deficit of visual acuity * The presence of severe deficit in communication and severe dysmetry

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

About this trial

In the sponsor's words

The aim of htis study is to investigate the post intervention effects of daily feedback on actual physical activity levels derived from a wristworn accelerometer FITBIT combined with self-management training on in-clinic physical activity in persons with moderate to severe disability from MS.

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History

    1. Started

      Jul 2019

    2. Main results due

      Jul 2020

    3. Finished

      Sept 2020

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