Multiple Sclerosis
Conditions
Keywords
exercise, motivational interviewing
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALMotivational Interviewing
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.
DEVICEWristband physical activity monitor
The participant will wear a Fitbit wristband which will track the participant's daily steps and minutes of physical activity.
Sponsors
Oakland University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Steps Taken Over Course of the Study | 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
| Measure | Time frame | Description |
|---|---|---|
| Exercise Self-Efficacy Questionnaire | 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. |
| Multiple Sclerosis Self-Efficacy Scale | 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. |
| Multiple Sclerosis Impact Scale | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm All five participants had multiple sclerosis (MS). Four participants had relapsing-remitting MS and one participant had progressive-relating MS. Years since diagnosis of MS ranged from 9 years to 29 years. | 5 |
| Total | 5 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Pregnancy | 1 |
Baseline characteristics
| Characteristic | Single Arm | — |
|---|---|---|
| Age, Continuous | 53 years | — |
| Exercise Self-Efficacy | 72.58 units on a scale | — |
| Multiple Sclerosis Impact Scale | 73.8 units on a scale | — |
| Multiple Sclerosis Self-Efficacy Scale | 51.4 units on a scale | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 5 participants | — |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
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
Population: Only 3 of the 4 participants who completed the study were included in the step total. One participant walked too slowly due to her disease to trigger the wristband step monitor.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm | Total Steps Taken Over Course of the Study | 296,147 steps over 4 weeks |
Secondary
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
Population: The 4 participants who completed the study had baseline and end of study exercise self-efficacy measured.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Arm | Exercise Self-Efficacy Questionnaire | 73.65 score on a scale |
| Single Arm Mean Post-study Score | Exercise Self-Efficacy Questionnaire | 91.75 score on a scale |
Secondary
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
Population: The 4 participants who completed the study had their end of study score compared to their baseline score.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Arm | Multiple Sclerosis Impact Scale | 78.25 score on a scale |
| Single Arm Mean Post-study Score | Multiple Sclerosis Impact Scale | 65 score on a scale |
Secondary
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
Population: The 4 participants who competed the study had post-study scores compared to baseline scores.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Single Arm | Multiple Sclerosis Self-Efficacy Scale | 48.25 score on a scale |
| Single Arm Mean Post-study Score | Multiple Sclerosis Self-Efficacy Scale | 47.25 score on a scale |