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

NCT02335450 | Completed Results

• 1 other identifier: 619511-2
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

exercise; motivational interviewing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Exercise Self-Efficacy Questionnaire

  baseline and at end of 4-week intervention

• Multiple Sclerosis Self-Efficacy Scale

  baseline compared to end of 4-week study

• Multiple Sclerosis Impact Scale

  baseline compared to end of 4-week study

Study Arms (1)

Single Arm

EXPERIMENTAL

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.

Behavioral: Motivational Interviewing; Device: Wristband physical activity monitor

Interventions

Motivational Interviewing BEHAVIORAL

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.

Also known as: Coaching

Single Arm

Wristband physical activity monitor DEVICE

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

Single Arm

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oakland University: lead

Study Sites (1)

Oakland University

Rochester, Michigan, 48309, United States

Location

Related 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.

  PMID: 25160577 BACKGROUND

• 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.

  PMID: 19903131 BACKGROUND

• 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.

  PMID: 19619337 BACKGROUND

• 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.

  PMID: 15165658 BACKGROUND

• 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.

  PMID: 24453744 BACKGROUND

• 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.

  PMID: 23599354 BACKGROUND

• 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.

  PMID: 16042230 BACKGROUND

• 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.

  PMID: 14742602 BACKGROUND

• 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.

  PMID: 12617272 BACKGROUND

• 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.

  PMID: 12900694 BACKGROUND

• 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.

  PMID: 1574662 BACKGROUND

• 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.

  PMID: 24942478 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Limitations and Caveats

This was a small case series qualitative design study.

Results Point of Contact

• Title: Beth Black
• Organization: Oakland University

bblack@oakland.edu

248-364-8694

Study Officials

• Beth Black, DSc

  Oakland University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Prof Physical Therapy, Health Sciences

Study Record Dates

• First Submitted: January 7, 2015
• First Posted: January 9, 2015
• Study Start: February 12, 2015
• Primary Completion: November 12, 2015
• Study Completion: November 12, 2015
• Last Updated: June 2, 2021
• Results First Posted: August 13, 2020

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Information will be shared 6 months after publication for one year.
• Access Criteria: Principal investigator will consider written request for study protocol and results.

Locations

US (1)