MSFrontier

MStep

The Role of Exercise in Modifying Outcomes for People With Multiple Sclerosis
Status unknownNot a drug-phase studyEarly (CIS/RIS)NCT01611987

What it found

Result in a paper, not read yet

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

What was tested

Treatment tested

  • MStep

Compared with

  • General guideline approach

What it measured

Main measures

  • oxygen consumption

    3 timepoints: baseline, at 12 monts, at 24 months

    Physical function

Other measures (11)

  • muscle strength measured with Biodex

    3 timepoints: Baseline, at 12 months, at 24 months

    Physical function

  • 6 Minute Walk test (6MWT)

    5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months

    Walking and mobility

  • Anaerobic leg power

    1 timepoint: baseline

    Physical function

  • Patient Determined Disease Steps (PDDS)

    5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months

    Walking and mobilityPhysical function

  • Change in fatigue levels

    5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months

    Fatigue

  • Rand 36

    5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months

  • EQ-5D

    5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months

    Quality of life (reported by participants)

  • Patient generated Index

    5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months

  • Exercise Self-Efficacy Scale

    5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months

    Physical function

  • Change in perception about exercise benefits and exercise barrier

    5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months

    Physical function

Who could take part

Early (CIS/RIS) · 19 to 65

Inclusion Criteria: * be community dwelling individuals aged 19 -65 who have been diagnosed after 1994 with MS or CIS; * be able to speak and read English or French; * be capable of walking 100 meters without a walking aid (EDSS ≤ 5.5), even if they do use an aid for daily activities. Exclusion Criteria: * have an additional illness that restricts their function; and/or * had suffered at least one relapse during the past 30 days (as defined by Polman) as this may affect physical activity/exercise participation.

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

About this trial

In the sponsor's words

Despite the benefits of exercise and physical activity people with Multiple Sclerosis (MS) are relatively inactive. Physical activity is important for persons with disabilities to maintain physical function. A lack of physical activity can contribute to heart disease, osteoporosis, obesity, and diabetes. At the moment, the best way for people with MS to exercise and be physical activity is unknown. People with MS report not knowing what to do. This is a barrier to exercise. The global aim of this study is to contribute evidence for the role of targeted exercise in altering MS outcomes over time. The design is a randomized controlled trial (RCT). The primary research question is to what extent does an MS Tailored Exercise Program (MSTEP) result in greater improvements in exercise capacity and related outcomes in comparison to a program based on general guidelines for exercise among people with MS who are sedentary and wish to engage in exercise as part of MS self-management. The primary outcome for this question is exercise capacity measured using cycle ergometry. However exercise efficiency, functional ambulation, strength, components of quality of life including frequency and intensity of fatigue symptoms, mood, global physical function, health perception, and illness intrusiveness, will also be measured as components of a global response outcome. The first confirmatory hypothesis is that MSTEP will result in a greater proportion of people making clinically relevant gains (at least 10% change) in exercise capacity than with general guidelines after 12 months of intervention; a secondary hypothesis is that, while there may be some decline in exercise capacity among individuals from end of intervention to follow-up one year later, the decline will be greater in the general guideline group augmenting the difference between groups in the proportion making 10% change from study entry to 24 months. In other words, gains will be maintained more for the MSTEP group over the general guideline group. An exploratory hypothesis is that more of the targeted outcomes will improve with the MSTEP program than the general guideline approach. An explanatory hypothesis is that these gains will be accompanied by reports of greater exercise enjoyment and exercise self-efficacy (confidence) with the MSTEP program than with the general guideline program leading to more consistent exercise engagement and improved long-term adherence.

Papers

Loading reviews and guidelines…

History

    1. Started

      Sept 2012

    2. Main results due

      Dec 2017

    3. Finished

      Dec 2018

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