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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335450
• Other study ID #: 619511-2
• Status: Completed
• Phase: N/A
• Start date: February 12, 2015
• Est. completion date: November 12, 2015

Study information

• Verified date: June 2021
• Source: Oakland University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: November 12, 2015
• Est. primary completion date: November 12, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Motivational 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.

Device:
• Wristband physical activity monitor
The participant will wear a Fitbit wristband which will track the participant's daily steps and minutes of physical activity.

Locations

Country	Name	City	State
United States	Oakland University	Rochester	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Oakland University

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View 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. — View Citation

Craig CL, Marshall AL, Sjöström 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. — View 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. — View 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. — View 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. — View Citation

Motl RW, McAuley E, Snook EM. Physical activity and multiple sclerosis: a meta-analysis. Mult Scler. 2005 Aug;11(4):459-63. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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.	baseline and at end of 4-week intervention
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.	baseline compared to end of 4-week study
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.	baseline compared to end of 4-week study