Trial Outcomes & Findings for Theory Based Intervention Program to Support Physical Activity for Individuals With Multiple Sclerosis: a Case Series (NCT NCT02335450)

NCT ID: NCT02335450

Last Updated: 2021-06-02

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 5 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2021-06-02

Participant Flow

Participant milestones

Measure	Single Arm The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use 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 and keep a daily physical activity log.
Overall Study STARTED	5
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

Single Arm The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use 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 and keep a daily physical activity log.

Overall Study Pregnancy

1

Baseline Characteristics

All 5 participants completed baseline questionnaires.

Baseline characteristics by cohort

Measure	Single Arm n=5 Participants 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.
Age, Continuous	53 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants • All 5 participants completed baseline questionnaires.
Sex: Female, Male Male	0 Participants n=5 Participants • All 5 participants completed baseline questionnaires.
Region of Enrollment United States	5 participants n=5 Participants • All 5 participants completed baseline questionnaires.
Exercise Self-Efficacy	72.58 units on a scale n=5 Participants
Multiple Sclerosis Impact Scale	73.8 units on a scale n=5 Participants
Multiple Sclerosis Self-Efficacy Scale	51.4 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Single Arm n=3 Participants The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use 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 and fill out a daily physical activity log to track their progress in meeting their activity goals. 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.	Single Arm Mean Post-study Score The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use 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 and keep a daily physical activity log.
Total Steps Taken Over Course of the Study	296,147 steps over 4 weeks	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Single Arm n=4 Participants The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use 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 and fill out a daily physical activity log to track their progress in meeting their activity goals. 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.	Single Arm Mean Post-study Score n=4 Participants The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use 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 and keep a daily physical activity log.
Exercise Self-Efficacy Questionnaire	73.65 score on a scale Interval 58.3 to 100.0	91.75 score on a scale Interval 77.0 to 100.0

SECONDARY outcome

Timeframe: baseline compared to end of 4-week study

Population: The 4 participants who competed the study had post-study scores compared to baseline scores.

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.

Outcome measures

Measure	Single Arm n=4 Participants The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use 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 and fill out a daily physical activity log to track their progress in meeting their activity goals. 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.	Single Arm Mean Post-study Score n=4 Participants The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use 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 and keep a daily physical activity log.
Multiple Sclerosis Self-Efficacy Scale	48.25 score on a scale Interval 40.0 to 69.0	47.25 score on a scale Interval 28.0 to 66.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Single Arm n=4 Participants The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use 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 and fill out a daily physical activity log to track their progress in meeting their activity goals. 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.	Single Arm Mean Post-study Score n=4 Participants The participants will be visited in their homes by a physical therapist once a week. The physical therapist will use 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 and keep a daily physical activity log.
Multiple Sclerosis Impact Scale	78.25 score on a scale Interval 37.0 to 109.0	65 score on a scale Interval 34.0 to 77.0

Adverse Events

Single Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Beth Black

Oakland University

Phone: 248-364-8694

Email: bblack@oakland.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place