Efficacy of Project BIPAMS for Restless Legs Syndrome in Adults With Multiple Sclerosis: A Pilot Study

CompletedNot a drug-phase studyMS (type not specified)NCT04061681

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

  • Behavioral Intervention (BIPAMS)

What it measured

Main measures

  • Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale

    Baseline

  • Restless Legs Syndrome Severity as measured by the International Restless Legs Syndrome Study Group Scale

    Follow-Up

  • Physical Activity Levels as measured by the Godin Leisure-Time Exercise Questionnaire

    Baseline

    Physical function
  • Physical Activity Levels as measured by the Godin Leisure-Time Exercise Questionnaire

    Follow-Up

    Physical function

Other measures (6)

  • Sleep Quality as measured by the Pittsburgh Sleep Quality Index

    Baseline

    Mood and sleep
  • Sleep Quality as measured by the Pittsburgh Sleep Quality Index

    Follow-up

    Mood and sleep
  • Sleep Quality as measured by accelerometry

    Baseline

    Myelin repairMood and sleep
  • Sleep Quality as measured by accelerometry

    Follow-up

    Myelin repairMood and sleep
  • Daytime Sleepiness as measured by the Epworth Sleepiness Scale

    Baseline

    Walking and mobilityMood and sleep
  • Daytime Sleepiness as measured by the Epworth Sleepiness Scale

    Follow-up

    Walking and mobilityMood and sleep

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* Diagnosis of multiple sclerosis * Relapse free in the past 30 days * Positive screen for restless legs syndrome * Non-active (not engaging in 30 minutes of activity per day on more than 2 days per week in the previous six months) * Ambulatory without assistance * Internet and email access

Exclusion criteria

* Diagnosis of radiculopathy, peripheral edema, peripheral neuropathy, iron deficiency (i.e., anemia) renal disease, or diabetes * Screen at moderate or high risk for undertaking strenuous or maximal exercise

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

About this trial

In the sponsor's words

The purpose of this study is to evaluate the efficacy of a 16-week behavioral intervention for increasing physical activity and reducing restless legs syndrome (RLS) severity in persons with multiple sclerosis (MS) and RLS. The study includes a proposed sample of 20 persons with MS and RLS that will be randomized into either a 16-week behavioral intervention arm aimed at increasing physical activity or a 16-week wait-list control arm.

Papers

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History

    1. Started

      Jan 2020

    2. Main results due

      Nov 2020

    3. Finished

      Nov 2020

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