BIPAMS-Brain:Examining the Neural Effects of a Behavioral Intervention for Physical Activity in Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT04496804

What it found

No results found

We found no results in the registry or in papers.

This trial finished 5 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Behavioral Intervention for Physical Activity in MS (BIPAMS)

Placebo

  • Wellness for MS (WellMS)

What it measured

Main measures

  • Minutes of moderate to vigorous physical activity - Baseline

    Assessment will be conducted before the intervention

    Physical function
  • Minutes of moderate to vigorous physical activity - Post intervention

    Assessment will be conducted immediately after the intervention

    Physical function

Other measures (10)

  • cardiorespiratory fitness; oxygen consumption during exercise - baseline

    Assessment will be conducted before the intervention

    Walking and mobilityPhysical function
  • cardiorespiratory fitness; oxygen consumption during exercise - post intervention

    Assessment will be conducted immediately after the intervention

    Walking and mobilityPhysical function
  • distance walked - baseline

    Assessment will be conducted before the intervention

    Walking and mobility
  • distance walked - post-intervention

    Assessment will be conducted immediately after the intervention

    Walking and mobility
  • information processing speed; cognitive function - baseline

    Assessment will be conducted before the intervention

    Thinking and memory
  • information processing speed; cognitive function - post intervention

    Assessment will be conducted immediately after the intervention

    Thinking and memory
  • volume of subcortical grey matter brain structures - baseline

    Assessment will be conducted before the intervention

    MRI lesions
  • volume of subcortical grey matter brain structures - post intervention

    Assessment will be conducted immediately after the intervention

    MRI lesions
  • resting state functional brain connectivity - baseline

    Assessment will be conducted before the intervention

    MRI lesionsNerve conduction tests
  • resting state functional brain connectivity - post intervention

    Assessment will be conducted immediately after the intervention

    MRI lesionsNerve conduction tests

Who could take part

MS (type not specified) · 18 to 45

Show the full criteria

Inclusion criteria

* diagnosis of multiple sclerosis * relapse free in the last 30 days * being non-active defined as not engaging in regular activity (30 minutes accumulated per day) on more than 2 days of the week during the previous 6 months * ambulate without assistance * low risk for contraindications for MRI

Exclusion criteria

* 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

Multiple sclerosis [MS] is a prevalent neurological disease that is the leading cause of irreversible neurological disability among young women and the second leading cause of disability among young men in the United States. This disease results in the progressive loss of walking mobility and substantial worsening of cognition, symptoms, and quality of life over time. There is evidence that physical activity is beneficially associated with aerobic fitness and brain structure and function in persons with MS. Nevertheless, this population is strikingly sedentary and physically inactive. This highlights a vital opportunity to improve aerobic fitness and brain health by developing behavioral interventions that increase physical activity. To that end, this project is a Phase-II randomized control trial for examining the efficacy of a behavioral intervention that is based on social-cognitive theory and delivered through the Internet for increasing physical activity and, secondarily, improving aerobic fitness and brain structure and function in persons with MS.

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History

    1. Started

      Nov 2020

    2. Main results due

      Nov 2021

    3. Finished

      Nov 2021

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