Step it Up: An Exercise and Behaviour Change Programme for People With

A Randomised Controlled Trial of an Exercise Plus Behaviour Change Intervention in People With MS: the "Step it Up" Study Protocol

CompletedNot a drug-phase studyMS (type not specified)NCT02301442

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

  • Exercise + behaviour change intervention

Compared with

  • Exercise + control education

What it measured

Main measures

  • Change in walking mobility from weeks 1 to 36

    Weeks 1 to 36

    Walking and mobility

Other measures (7)

  • Change in lower limb functional muscle strength from weeks 1 to 36

    Weeks 1 to 36

    Physical function

  • Change in aerobic fitness from weeks 1 to 36

    Weeks 1 to 36

    Physical function

  • Change in anxiety and depression from weeks 1 to 36

    Weeks 1 to 36

    Mood and sleep

  • Change in cognitive processing from weeks 1 to 36

    Weeks 1 to 36

    Thinking and memory

  • Change in physical activity levels from weeks 1 to 36

    Weeks 1 to 36

    Physical function

  • Change in self-reported fatigue from weeks 1 to 36

    Weeks 1 to 36

    Fatigue

  • Change in self-reported impact of MS from weeks 1 to 36

    Weeks 1 to 36

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* Physician-confirmed formal diagnosis of MS * Patient Determined Disease Steps score of 0-3 * A sedentary lifestyle (\< 30 minutes of moderate to strenuous exercise one day or more per week over the last six months) * Willing to give written informed consent.

Exclusion criteria

* Pregnancy * MS relapse in the last 12 weeks * Changes to MS medication or steroid treatment in the last 12 weeks.

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

About this trial

In the sponsor's words

Exercise has consistently yielded short-term, positive effects on health outcomes in people with multiple sclerosis (MS). However, these effects have not been maintained in the long-term. Behaviour change interventions aim to promote long-term positive lifestyle change. This study, namely, "Step it Up" will compare the effectiveness of an exercise plus Social Cognitive Theory (SCT)-based behaviour change intervention with an exercise plus control education intervention on walking mobility among people with MS.

Papers

Loading reviews and guidelines…

History

    1. Started

      Sept 2014

    2. Main results due

      Feb 2016

    3. Finished

      Feb 2016

    Assembled by software from public sources.