An interventional study of Motivational Interviewing and Wristband physical activity monitor in Multiple Sclerosis, sponsored by Oakland University. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2021-06-02.
Sponsored by Oakland University · Not applicable, Interventional, and Treatment
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.
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.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 5 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Oakland University is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All five participants in the study will receive this intervention. The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use a coaching technique called motivational interviewing to help the participant develop personal physical activity goals. The participant will discuss their physical activity challenges, and with the help of the physical therapist the participant will set up personal physical activity goals for the following week. The participant will be given a wristband physical activity monitor to wear during the day for four weeks to track their progress in meeting their activity goals.
Behavioral: Motivational Interviewing · Device: Wristband physical activity monitor
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.
Also known as: Coaching
The participant will wear a Fitbit wristband which will track the participant's daily steps and minutes of physical activity.
Total Steps Taken Over Course of the Study
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.
Time frame: 4 weeks
Exercise Self-Efficacy Questionnaire
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.
Time frame: baseline and at end of 4-week intervention
Multiple Sclerosis Self-Efficacy Scale
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.
Time frame: baseline compared to end of 4-week study
Multiple Sclerosis Impact Scale
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.
Time frame: baseline compared to end of 4-week study
| Milestone | Single Arm |
|---|---|
| Started | 5 |
| Completed | 4 |
| Not completed | 1 |
| Withdrew: Pregnancy | 1 |
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.
| steps over 4 weeks | Single Arm |
|---|---|
| Total Steps Taken Over Course of the Study | 296,147 |
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.
| score on a scale | Single Arm Mean Baseline Score | Single Arm Mean Post-study Score |
|---|---|---|
| Exercise Self-Efficacy Questionnaire | 73.65 (58.30 to 100) | 91.75 (77.00 to 100) |
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.
| score on a scale | Single Arm Mean Baseline Score | Single Arm Mean Post-study Score |
|---|---|---|
| Multiple Sclerosis Self-Efficacy Scale | 48.25 (40 to 69) | 47.25 (28 to 66) |
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.
| score on a scale | Single Arm Baseline Mean Score | Single Arm Post-study Mean Score |
|---|---|---|
| Multiple Sclerosis Impact Scale | 78.25 (37 to 109) | 65 (34 to 77) |
Collected over 5 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Single Arm | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
All 5 participants completed baseline questionnaires.
| Age, Continuous(years) | Single Arm |
|---|---|
| Mean | 53 (36 to 69) |
| Sex: Female, Male(Participants) | Single Arm |
|---|---|
| Female | 5 |
| Male | 0 |
| Race and Ethnicity Not Collected(Participants) | Single Arm |
|---|
| Region of Enrollment(participants) | Single Arm |
|---|---|
| United States | 5 |
| Exercise Self-Efficacy(units on a scale) | Single Arm |
|---|---|
| Mean | 72.58 (58.3 to 100.00) |
| Multiple Sclerosis Impact Scale(units on a scale) | Single Arm |
|---|---|
| Mean | 73.8 (37.0 to 109.0) |
| Multiple Sclerosis Self-Efficacy Scale(units on a scale) | Single Arm |
|---|---|
| Mean | 51.4 (40.0 to 69.0) |
Plan to share: Yes — All IPD that underlie results in a publication
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Oakland University