Clinical trial NCT02335450: Theory Based Intervention Program to Support Physical Activity for Individuals With Multiple Sclerosis: a Case Series
Official title: Theory Based Intervention Program to Support Physical Activity for Individuals With Multiple Sclerosis: a Case Series
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: exercise
motivational interviewing
Lead sponsor: Oakland University
Sponsor class: OTHER
First posted: 2015-01-09
Enrollment: 5
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Total Steps Taken Over Course of the Study
timeFrame: 4 weeks
Secondary outcomes:
measure: Exercise Self-Efficacy Questionnaire
timeFrame: baseline and at end of 4-week intervention
measure: Multiple Sclerosis Self-Efficacy Scale
timeFrame: baseline compared to end of 4-week study
measure: Multiple Sclerosis Impact Scale
timeFrame: baseline compared to end of 4-week study
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Oakland University
state: Michigan
Study officials:
affiliation: Oakland University
name: Beth Black, DSc
role: PRINCIPAL_INVESTIGATOR
References:
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