Project BIPAMS: Behavioral Intervention for Physical Activity in Multiple Sclerosis

Running, not recruitingNot a drug-phase studyMS (type not specified)NCT03490240

What it found

Still running

No result yet.

What was tested

Treatment tested

  • BIPAMS

Compared with

  • WELLMS

What it measured

Main measures

  • Change of Physical Activity levels through Accelerometery from baseline at 6 and 12 months.

    Baseline through 12 months

    Physical function
  • Change of Physical Activity levels through the Godin Leisure-Time Exercise Questionnaire from baseline at 6 and 12 months.

    Baseline through 12 months.

    Physical function
  • Change of Physical Activity levels through the Abbreviated International Physical Activity Questionnaire from baseline at 6 and 12 months.

    Baseline through 12 months.

    Physical function

Other measures (11)

  • Change of self-report measures of walking through the Multiple Sclerosis Walking Scale - 12 from baseline at 6 and 12 months

    Baseline through 12 months

    Walking and mobility
  • Change of self-report measures of Walking through the Patient Determined Disease Steps Scale from baseline at 6 and 12 months.

    Baseline through 12 months

    Walking and mobility
  • Change of self-report measures of Cognition through the Perceived Deficits Questionnaire from baseline at 6 and 12 months.

    Baseline through 12 months

    Thinking and memory
  • Change of self-report measures of Cognition through the Multiple Sclerosis Neuropsychological Questionnaire from baseline at 6 and 12 months.

    Baseline through 12 months

    Thinking and memory
  • Change of self-report measures of Fatigue through the Fatigue Severity Scale from baseline at 6 and 12 months.

    Baseline through 12 months

    Fatigue
  • Change of self-report measures of Fatigue through the Modified Fatigue Impact Scale at 6 and 12 months from baseline.

    Baseline through 12 months

    Fatigue
  • Change of self-report measures of Anxiety and Depression through the Hospital Anxiety and Depression Scale at 6 months and 12 months from baseline.

    Baseline through 12 months

    Mood and sleep
  • Change of self-report measures of Pain through the Short-form of McGill Pain Questionnaire at 6 and 12 months from baseline.

    Baseline through 12 months

    Pain
  • Changes of self-report measures of sleep through the Pittsburgh Sleep Quality Index at 6 and 12 months from baseline.

    Baseline through 12 months

    Mood and sleep
  • Changes of self-report measures of quality of life through the Medical Outcomes Study Short Form-36 at 6 and 12 months from baseline.

    Baseline through 12 months

    Quality of life (reported by participants)

Who could take part

MS (type not specified) · 18 to 64

Show the full criteria

Inclusion criteria

* Diagnosis of MS * Relapse free in the past 30 days * Internet and email access * Willingness to complete the questionnaires, wear the accelerometer, and undergo randomization * 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 six months * Ability to ambulate with or without assistance (i.e. walking with or without a can or walker, but not a wheelchair) * Age between 18 and 64

Exclusion criteria

* Moderate or high risk for undertaking strenuous or maximal exercise per participants response to the PAR-Q. Those who report no more than one YES or affirmative on the 7 item PAR-Q will be considered at low risk and included for participation. All others will be considered at moderate or high risk and excluded from participation.

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

About this trial

In the sponsor's words

This randomized controlled trial will examine the effect of a 6-month behavioral intervention, based on social cognitive theory and delivered through the Internet, for increasing physical activity and secondarily improving mobility, cognition, symptoms and quality of life in persons with MS. The investigators hypothesize that individuals who receive the 6-month behavioral intervention will demonstrate an increase in physical activity behavior that will last throughout a 6-month follow up compared with participants in the control condition. The investigators further hypothesize that individuals in the behavioral intervention will demonstrate better walking mobility and cognitive function, reduced fatigue, depression, anxiety, and pain, and improved quality of life compared to the control condition. The investigators hypothesize that the behavioral intervention will increase physical activity through positive changes in self-efficacy, outcome expectations, goal setting, and impediments as social-cognitive determinants.

Papers

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History

    1. Started

      Mar 2018

    2. Main results due

      Mar 2023

    3. Finished

      Dec 2026

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