Physical Activity Intervention for Persons Newly Diagnosed With Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT05641532

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 3 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Physical activity behavioral intervention in persons newly diagnosed with MS

What it measured

Main measures

  • Feasibility metric: Process

    12 weeks

    Quality of life (reported by participants)Feasibility
  • Feasibility metric: Resource

    12 weeks

    Feasibility
  • Feasibility metric: Management

    12 weeks

    Feasibility
  • Feasibility metric: Overall safety

    12 weeks

    SafetyFeasibility
  • Change of Physical Activity levels through Accelerometry from baseline and 12 weeks

    12 weeks

    Physical function
  • Change of Physical Activity levels through the Godin Leisure-Time Exercise Questionnaire from baseline and 12 weeks

    12 weeks

    Physical function
  • Change of Physical Activity levels through the Abbreviated International Physical Activity Questionnaire from baseline and 12 weeks

    12 weeks

    Physical function

Other measures (3)

  • Change of self-report measures of Fatigue through the Fatigue Severity Scale from baseline and 12 weeks

    12 weeks

    Fatigue
  • Changes of self-report measures of quality of life through the Multiple Sclerosis Impact Scale-29 at baseline and 12 weeks

    12 weeks

    Quality of life (reported by participants)
  • Formative evaluation

    12 weeks

    Quality of life (reported by participants)

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* ≥ 18 years old * Diagnosed with multiple sclerosis for 2 or fewer years * Fully ambulatory * No relapse within the last 30 days * Non-active (Godin Leisure-Time Exercise Questionnaire - Health Contribution Score \< 14) * Able to read 14-point font size * Internet \& video conferencing access * Undergoing disease-modifying therapy

Exclusion criteria

* Pregnancy * Moderate or high risk for undertaking physical activity (≥ 2 affirmatives on the Physical Activity Readiness Questionnaire)

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

About this trial

In the sponsor's words

This single group pre-post pilot intervention will examine the feasibility and initial effect of a 12-week behavioral intervention, based on the Behavior Change Wheel and Capability-Opportunity-Motivation-Behavior (COM-B) model and remotely delivered through electronic newsletters and online one-on-one video conferencing, for promoting physical activity and secondarily reducing fatigue and quality of life in persons newly diagnosed with MS (diagnosed with MS within the past 2 years). The investigators hypothesize the proposed 12-week intervention will be feasible based on process, resource, management, and scientific outcomes. The investigators further hypothesize that individuals who receive the 12-week intervention will demonstrate an increase in physical activity behavior, particularly daily step counts, and reduce fatigue.

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History

    1. Started

      Jan 2023

    2. Main results due

      Aug 2023

    3. Finished

      Aug 2023

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