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

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing
Wristband physical activity monitor
Sponsored by
Oakland University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring exercise, motivational interviewing

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Oakland University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 7, 2015
Last Updated
June 1, 2021
Sponsor
Oakland University
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1. Study Identification

Unique Protocol Identification Number
NCT02335450
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
February 12, 2015 (undefined)
Primary Completion Date
November 12, 2015 (Actual)
Study Completion Date
November 12, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oakland University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
exercise, motivational interviewing

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Other Intervention Name(s)
Coaching
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Wristband physical activity monitor
Intervention Description
The participant will wear a Fitbit wristband which will track the participant's daily steps and minutes of physical activity.
Primary Outcome Measure Information:
Title
Total Steps Taken Over Course of the Study
Description
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
Secondary Outcome Measure Information:
Title
Exercise Self-Efficacy Questionnaire
Description
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
Title
Multiple Sclerosis Self-Efficacy Scale
Description
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
Title
Multiple Sclerosis Impact Scale
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth Black, DSc
Organizational Affiliation
Oakland University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oakland University
City
Rochester
State/Province
Michigan
ZIP/Postal Code
48309
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication
IPD Sharing Time Frame
Information will be shared 6 months after publication for one year.
IPD Sharing Access Criteria
Principal investigator will consider written request for study protocol and results.
Citations:
PubMed Identifier
25160577
Citation
Borkoles E, Nicholls AR, Bell K, Butterly R, Polman RC. The lived experiences of people diagnosed with multiple sclerosis in relation to exercise. Psychol Health. 2008;23(4):427-41. doi: 10.1080/14768320701205309.
Results Reference
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PubMed Identifier
19903131
Citation
Stroud N, Minahan C, Sabapathy S. The perceived benefits and barriers to exercise participation in persons with multiple sclerosis. Disabil Rehabil. 2009;31(26):2216-22. doi: 10.3109/09638280902980928.
Results Reference
background
PubMed Identifier
19619337
Citation
Stroud NM, Minahan CL. The impact of regular physical activity on fatigue, depression and quality of life in persons with multiple sclerosis. Health Qual Life Outcomes. 2009 Jul 20;7:68. doi: 10.1186/1477-7525-7-68.
Results Reference
background
PubMed Identifier
15165658
Citation
Rimmer JH, Riley B, Wang E, Rauworth A, Jurkowski J. Physical activity participation among persons with disabilities: barriers and facilitators. Am J Prev Med. 2004 Jun;26(5):419-25. doi: 10.1016/j.amepre.2004.02.002.
Results Reference
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PubMed Identifier
24453744
Citation
Brown C, Kitchen K, Nicoll K. Barriers and facilitators related to participation in aquafitness programs for people with multiple sclerosis: a pilot study. Int J MS Care. 2012 Fall;14(3):132-41. doi: 10.7224/1537-2073-14.3.132.
Results Reference
background
PubMed Identifier
23599354
Citation
Motl RW, McAuley E, Sandroff BM. Longitudinal change in physical activity and its correlates in relapsing-remitting multiple sclerosis. Phys Ther. 2013 Aug;93(8):1037-48. doi: 10.2522/ptj.20120479. Epub 2013 Apr 18.
Results Reference
background
PubMed Identifier
16042230
Citation
Motl RW, McAuley E, Snook EM. Physical activity and multiple sclerosis: a meta-analysis. Mult Scler. 2005 Aug;11(4):459-63. doi: 10.1191/1352458505ms1188oa.
Results Reference
background
PubMed Identifier
14742602
Citation
McGuigan C, Hutchinson M. The multiple sclerosis impact scale (MSIS-29) is a reliable and sensitive measure. J Neurol Neurosurg Psychiatry. 2004 Feb;75(2):266-9.
Results Reference
background
PubMed Identifier
12617272
Citation
Rigby SA, Domenech C, Thornton EW, Tedman S, Young CA. Development and validation of a self-efficacy measure for people with multiple sclerosis: the Multiple Sclerosis Self-efficacy Scale. Mult Scler. 2003 Feb;9(1):73-81. doi: 10.1191/1352458503ms870oa.
Results Reference
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PubMed Identifier
12900694
Citation
Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.
Results Reference
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PubMed Identifier
1574662
Citation
Marcus BH, Selby VC, Niaura RS, Rossi JS. Self-efficacy and the stages of exercise behavior change. Res Q Exerc Sport. 1992 Mar;63(1):60-6. doi: 10.1080/02701367.1992.10607557.
Results Reference
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PubMed Identifier
24942478
Citation
O'Halloran PD, Blackstock F, Shields N, Holland A, Iles R, Kingsley M, Bernhardt J, Lannin N, Morris ME, Taylor NF. Motivational interviewing to increase physical activity in people with chronic health conditions: a systematic review and meta-analysis. Clin Rehabil. 2014 Dec;28(12):1159-71. doi: 10.1177/0269215514536210. Epub 2014 Jun 18.
Results Reference
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Theory Based Intervention Program to Support Physical Activity for Individuals With Multiple Sclerosis: a Case Series

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