Theory Based Intervention Program to Support Physical Activity for Individuals With Multiple Sclerosis: a Case Series

CompletedNot a drug-phase studyMS (type not specified)NCT02335450

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

  • Motivational Interviewing
  • Wristband physical activity monitor

Results by group

Total Steps Taken Over Course of the Study

4 weeks

GroupValueIntervalNumber analysed
Single Arm296,147 steps over 4 weeks3

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Single Arm50 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • Total Steps Taken Over Course of the Study

    4 weeks

    Physical function

Other measures (3)

  • Exercise Self-Efficacy Questionnaire

    baseline and at end of 4-week intervention

    Physical function
  • Multiple Sclerosis Self-Efficacy Scale

    baseline compared to end of 4-week study

    Quality of life (reported by participants)
  • Multiple Sclerosis Impact Scale

    baseline compared to end of 4-week study

Who could take part

MS (type not specified) · 19 and over

Show the full criteria

Inclusion criteria

* must have a physician diagnosis of multiple sclerosis and deemed suitable for engaging in a physical activity program by their physician * must be ambulatory with or without an assistive device * must be able to speak and read English * must have a home computer or device capable of tracking and recording the daily Fitbit physical activity reports

Exclusion criteria

* participants will be excluded if any contraindications to engaging in independent exercise are identified during the intake examination by the physical therapist: cardiovascular issues or safety issues with walking.

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

About this trial

In the sponsor's words

This study evaluates the effectiveness of personalized physical activity coaching combined with the use of a physical activity monitor to support increased levels of daily physical activity in individuals with multiple sclerosis. All five participants will receive the intervention over the four week intervention phase.

Papers

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History

    1. Started

      Feb 2015

    2. Main results due

      Nov 2015

    3. Finished

      Nov 2015

    4. Results posted

      Aug 2020

    Assembled by software from public sources.