Multiple SclerosisNCT02335450
Theory Based Intervention Program to Support Physical Activity for Individuals With Multiple Sclerosis: a Case Series
A study testing Motivational Interviewing and Wristband physical activity monitor in people with Multiple Sclerosis, run by Oakland University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Motivational Interviewing and Wristband physical activity monitor
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2015to 12 Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Motivational Interviewing, Wristband physical activity monitor
- Keywords
- exercise, motivational interviewing
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
Also called Coaching
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.
Wristband physical activity monitorDevice
The participant will wear a Fitbit wristband which will track the participant's daily steps and minutes of physical activity.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Motivational Interviewing; Device: Wristband physical activity monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
Secondary outcomes (3)
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.
Measured: baseline and at end of 4-week intervention
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.
Measured: baseline compared to end of 4-week study
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.
Measured: baseline compared to end of 4-week study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2015 (estimated)
- Study start12 Feb 2015
- Primary completion12 Nov 2015
- Study completion12 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oakland University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beth Black, Oakland University
- Investigators
- Beth Black, DSc, Principal investigator, Oakland University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335450
- Sponsor's protocol ID
- 619511-2
- Status last verified
- Jun 2021
- First submitted
- 7 Jan 2015
- Last updated
- 2 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
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.
PubMed 25160577Stroud 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.
PubMed 19903131Stroud 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.
PubMed 19619337Rimmer 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.
PubMed 15165658Brown 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.
PubMed 24453744Motl 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.
PubMed 23599354Motl 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.
PubMed 16042230McGuigan 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.
PubMed 14742602Rigby 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.
PubMed 12617272Craig 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.
PubMed 12900694Marcus 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.
PubMed 1574662O'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.
PubMed 24942478
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theory Based Intervention Program to Support Physical Activity for Individuals With Multiple Sclerosis: a Case Series
- ClinicalTrials.gov ID
- NCT02335450
- Acronym / sponsor ID
- 619511-2
- Conditions
- Multiple Sclerosis
- Keywords
- exercise, motivational interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Oakland UniversityUniversity, hospital or other
- Study start
- 12 Feb 2015
- Primary completion
- 12 Nov 2015 (actual)
- Study completion
- 12 Nov 2015 (actual)
- First posted
- 9 Jan 2015 (estimated)
- Results
- Posted 13 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Behavioral: Motivational Interviewing, Device: Wristband physical activity monitorAll 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational InterviewingAlso: CoachingThe 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. | Behavioural | Single Arm |
| Wristband physical activity monitorThe participant will wear a Fitbit wristband which will track the participant's daily steps and minutes of physical activity. | Device | Single Arm |
Primary outcome
Total Steps Taken Over Course of the Study
Time frame: 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.
3 secondary outcomes
Exercise Self-Efficacy Questionnaire
Time frame: baseline and at end of 4-week intervention
Multiple Sclerosis Self-Efficacy Scale
Time frame: baseline compared to end of 4-week study
Multiple Sclerosis Impact Scale
Time frame: baseline compared to end of 4-week study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25160577Borkoles 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.
- Background: PubMed 19903131Stroud 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.
- Background: PubMed 19619337Stroud 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.
- Background: PubMed 15165658Rimmer 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.
- Background: PubMed 24453744Brown 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.
- Background: PubMed 23599354Motl 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.
- Background: PubMed 16042230Motl 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.
- Background: PubMed 14742602McGuigan 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.
- Background: PubMed 12617272Rigby 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.
- Background: PubMed 12900694Craig 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.
- Background: PubMed 1574662Marcus 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.
- Background: PubMed 24942478O'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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
Related trials for Multiple Sclerosis
RecruitingPhase 1
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
B-cell Mediated Autoimmune Disorders
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity
Multiple Sclerosis Spasticity
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Primary Progressive Multiple Sclerosis
Multiple Sclerosis (MS) Primary Progressive
Active, not recruiting
Tai Chi Training for Persons With Multiple Sclerosis.
Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 3
A Study of Orelabrutinib in Patients With Secondary Progressive Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beth Black, DSc principal investigator
Oakland University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational Interviewing and Wristband physical activity monitor in people with Multiple Sclerosis, run by Oakland University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Steps Taken Over Course of the Study (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02335450, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.