NCT02335450

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

Completed NA Results posted Last updated 2 June 2021

What this trial tests

NA trial testing Motivational Interviewing in Multiple Sclerosis in 5 participants. Completed in 12 November 2015.

Timeline

12 February 2015

Primary endpoint
12 November 2015

12 November 2015

Quick facts

Lead sponsor	Oakland University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	5
Start date	12 February 2015
Primary completion	12 November 2015
Estimated completion	12 November 2015
Sites	1 location across United States

Drugs / interventions tested

• Motivational Interviewing
• Wristband physical activity monitor

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Oakland University

Who can join

19 and older, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Steps Taken Over Course of the Study Primary · 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.

Group	Value	95% CI
Single Arm	296,147

Exercise Self-Efficacy Questionnaire Secondary · 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.

Group	Value	95% CI
Single Arm Mean Baseline Score	73.65	58.30 – 100
Single Arm Mean Post-study Score	91.75	77.00 – 100

Multiple Sclerosis Self-Efficacy Scale Secondary · 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.

Group	Value	95% CI
Single Arm Mean Baseline Score	48.25	40 – 69
Single Arm Mean Post-study Score	47.25	28 – 66

Multiple Sclerosis Impact Scale Secondary · 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.

Group	Value	95% CI
Single Arm Baseline Mean Score	78.25	37 – 109
Single Arm Post-study Mean Score	65	34 – 77

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.