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Completed

NCT Number: NCT02335450

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Motor Activity Nervous System Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oakland University

Rochester, Michigan, 48309, United States

About this study

Individuals with multiple sclerosis engage in less daily physical activity than the general population for a variety of reasons. This research project is intended to evaluate whether individualized coaching combined with the use of a Fitbit physical activity wristband monitor will improve physical activity levels in individuals with multiple sclerosis.

Following admission into the study, participants will be visited once a week for four weeks at home by a physical therapist. The participants in consultation with the physical therapist will set daily physical activity goals for the following week and the participants will be taught how to monitor their daily activity using a Fitbit physical activity wristband.

The goals of this study are to determine whether this intervention is effective in helping participants increase their levels of daily physical activity and their confidence that they can successfully engage in daily physical activity. In addition, there will be an evaluation of changes from pre-intervention to post-intervention in quality of life measures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Motivational Interviewing

Behavioral

The participant will describe their unique physical activity challenges and their physical activity goals with the physical therapist. Using the technique of motivational interviewing, the physical therapist will work with the participant to help identify potential solutions to challenges and set realistic activity goals for the next week. Each week, the participant and the physical therapist will review the previous week's activity data, and the participant's reports of any challenges or problems they encountered in meeting their physical activity goals the previous week. The participant will identify new activity goals for the next week.

Other names: Coaching

Wristband physical activity monitor

Device

The participant will wear a Fitbit wristband which will track the participant's daily steps and minutes of physical activity.

Primary outcomes

  1. Total Steps Taken Over Course of the Study

    Time frame: 4 weeks

    Wristband physical activity monitor recorded steps taken by participant over the 4 weeks of the study. No minimum or maximum. No baseline taken so cannot compare pre-intervention to post intervention.

Secondary outcomes

  1. Exercise Self-Efficacy Questionnaire

    Time frame: baseline and at end of 4-week intervention

    The "Exercise Self-Efficacy Scale" is the participant's self-reported confidence in their ability to engage in exercise throughout the day. Each of the 6 items is scored from 0% confidence to 100% confidence. All items are summed and the score is divided by 6 Minimum score: 0 Maximum score:100 Higher scores mean a better outcome.

  2. Multiple Sclerosis Self-Efficacy Scale

    Time frame: baseline compared to end of 4-week study

    The "Multiple Sclerosis Self-Efficacy Scale" is a self-report of impact of multiple sclerosis on quality of life. The 14 statements are answered by selecting one of six options from strongly disagree to strongly agree.

    Minimum value: 14 Maximum value: 84 Higher scores reflect mean a better outcome.

  3. Multiple Sclerosis Impact Scale

    Time frame: baseline compared to end of 4-week study

    The "Multiple Sclerosis Impact Scale" is a self-report on how multiple sclerosis has impacted day-to-day life during the past 2 weeks. The 29 items are graded by the participants on a 5 point scale rating from "not at all" to "extremely".

    Minimum score: 29 Maximum Score:145 Higher scores mean worse outcome.

Sponsors and collaborators

Lead sponsor

Oakland University

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 9, 2015
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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