Views on Physical Activity Following a Relapse in People With Multiple Sclerosis

NCT03736902 | Completed DMC

• 1 other identifier: 248619
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Multiple Sclerosis (MS) is the most common cause of neurological disability in young adults. Relapsing Remitting Multiple Sclerosis (RRMS) is the most frequent form of MS at the time of diagnosis characterised by relapses, followed by remission. Relapses can result in a sudden change in physical or cognitive symptoms, often impacting a person's ability to function with family, friends and work. The National Institute for Health and Care Excellence (NICE) Clinical Guidelines for MS recommend encouraging people with MS to exercise regularly but does not provide specific advice on whether exercise should be undertaken during a relapse. Despite the wealth of literature documenting the benefits of exercise for people with MS insufficient evidence exists about exercise during relapse. Research has improved our understanding of what helps people with MS to be physically active and difficulties people encounter but has not provided evidence for how this is affected by a relapse. The aim of this study is to understand the attitudes of people with MS to physical activity following relapse, including factors that help them to be active and barriers to physical activity. The information gathered will be useful to inform future research and guide the advice health professionals may offer. Fifteen adults with RRMS who have had a relapse in the preceding 3-4 months will be recruited if their Expanded Disability Status Scale (EDSS) is \<7 (EDSS scale is used to quantify disability in MS and monitor changes in the level of disability over time) and they agree to being audio -recorded at interviews. The recruitment will take place at the weekly MS relapse clinic at a hospital in London, UK. Participants will be asked to complete two questionnaires (Patient Determined Disease Steps and the International Physical Activity Questionnaire), answer demographic questions and spend one hour being interviewed by a researcher. It is anticipated the recruitment and interviews be carried out by March 2019.

Conditions

Multiple Sclerosis

Keywords

Physical activity; Exercise; Relapse; Exacerbation; Attack

Outcome Measures

Primary Outcomes (1)

• Analysis of interview transcripts

  Framework analysis (Ritchie and Spencer, 1994)

  1 year

Interventions

Qualitative semi structured interview OTHER

One-to-one semi structured interviews, guided by the Physical Activity for people with a Disability Framework (van der Ploeg et al, 2004) which is a model for understanding the different factors that influence whether people with a disability engage in physical activity. Participants that agree to take part in the study, will be offered an interview either in a private clinic room at the hospital, at their home (if they live within a 40-mile radius of the hospital) or via a web-based video link. The interviews are expected to last one hour and will be conducted by the primary researcher.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be recruiting from the MS relapse clinic service at a hospital in London, UK. Patients that attend the clinic and meet the inclusion criteria will be eligible to participate.

You may qualify if:

• Adults (age 18 or over)
• Confirmed diagnosis of Relapsing Remitting Multiple Sclerosis
• Confirmed relapse diagnosed by a consultant neurologist or specialist registrar.
• Relapse within the four months preceding interview date (as most recovery is expected to have occurred by this time)
• Expanded Disability Status Scale (EDSS) score of \<7. The EDSS is a 0 - 10 scale used to quantify disability in multiple sclerosis and monitor changes in level of disability over time. A score of 0 represents no disability. The scale is widely used in clinical trials and in the assessment of people with MS. A score of \<7 has been chosen as people with a score of ≥7 and above are unable to walk more than five metres and are restricted to a wheelchair for the majority of the daytime and are likely to find it much more difficult to engage in physical activity.
• Agree to be audio-recorded during the interviews
• Patients who speak competent English. This will be assessed initially by the clinical treating team, as patients who can communicate their relapse history in English during the clinic are assumed to have adequate English to participate in this study. In addition, the researcher is an experienced clinical physiotherapist who is exposed to a range of language abilities. If the researcher does not feel the participant has enough English skills to consent, then they will exclude the participant from the study.

You may not qualify if:

• Patients who are under the age of 18. Children represent less that 5% of PwMS and their experience is likely to be different to adults.
• Adults unable to participate in an interview spoken in English. Non-English speakers are unable to participate in the study as there are no funds for the hire of interpreters or health advocates, or for the translation of study information or consent documents. In order to gain informed consent, complete the demographic questions, questionnaires and participate in the qualitative interviews with the researcher, participants will need to be able to be able to speak and fluent English.
• People with co-morbidities impacting on physical function in the last year (e.g. heart disease, arthritis, musculoskeletal injury).
• Adults lacking mental capacity to consent to take part in the research.
• People who want to be interviewed at home but live greater than 40 miles radius from the National Hospital for Neurology and Neurosurgery.
• People with a relapse more than four months from the date of interview. This has been chosen so that people that are interviewed have had a recent relapse, with their recovery experience is still fresh in their memory.
• Pseudo-relapse (e.g. from urinary tract infection of lower respiratory tract infection).

Sponsors & Collaborators

• City, University of London: lead
• University College London Hospitals: collaborator

Study Sites (1)

University College London Hospitals

London, Greater London, WC1N 3BG, United Kingdom

Location

Related Publications (35)

• Compston A, Coles A. Multiple sclerosis. Lancet. 2008 Oct 25;372(9648):1502-17. doi: 10.1016/S0140-6736(08)61620-7.

  PMID: 18970977 BACKGROUND

• Mackenzie IS, Morant SV, Bloomfield GA, MacDonald TM, O'Riordan J. Incidence and prevalence of multiple sclerosis in the UK 1990-2010: a descriptive study in the General Practice Research Database. J Neurol Neurosurg Psychiatry. 2014 Jan;85(1):76-84. doi: 10.1136/jnnp-2013-305450. Epub 2013 Sep 19.

  PMID: 24052635 BACKGROUND

• Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011 Feb;69(2):292-302. doi: 10.1002/ana.22366.

  PMID: 21387374 BACKGROUND

• Vollmer T. The natural history of relapses in multiple sclerosis. J Neurol Sci. 2007 May 15;256 Suppl 1:S5-13. doi: 10.1016/j.jns.2007.01.065. Epub 2007 Mar 7.

  PMID: 17346747 BACKGROUND

• Doshi A, Chataway J. Multiple sclerosis, a treatable disease. Clin Med (Lond). 2016 Dec;16(Suppl 6):s53-s59. doi: 10.7861/clinmedicine.16-6-s53.

  PMID: 27956442 BACKGROUND

• Motl RW, Sandroff BM, Kwakkel G, Dalgas U, Feinstein A, Heesen C, Feys P, Thompson AJ. Exercise in patients with multiple sclerosis. Lancet Neurol. 2017 Oct;16(10):848-856. doi: 10.1016/S1474-4422(17)30281-8. Epub 2017 Sep 12.

  PMID: 28920890 BACKGROUND

• Asano M, Raszewski R, Finlayson M. Rehabilitation interventions for the management of multiple sclerosis relapse: a short scoping review. Int J MS Care. 2014 Summer;16(2):99-104. doi: 10.7224/1537-2073.2013-031.

  PMID: 25061434 BACKGROUND

• Perrin Ross A, Williamson A, Smrtka J, Flemming Tracy T, Saunders C, Easterling C, Niewoehner J, Mutschler N. Assessing relapse in multiple sclerosis questionnaire: results of a pilot study. Mult Scler Int. 2013;2013:470476. doi: 10.1155/2013/470476. Epub 2013 May 26.

  PMID: 23766909 BACKGROUND

• Hirst CL, Ingram G, Pickersgill TP, Robertson NP. Temporal evolution of remission following multiple sclerosis relapse and predictors of outcome. Mult Scler. 2012 Aug;18(8):1152-8. doi: 10.1177/1352458511433919. Epub 2012 Jan 4.

  PMID: 22217582 BACKGROUND

• Nickerson M, Cofield SS, Tyry T, Salter AR, Cutter GR, Marrie RA. Impact of multiple sclerosis relapse: The NARCOMS participant perspective. Mult Scler Relat Disord. 2015 May;4(3):234-40. doi: 10.1016/j.msard.2015.03.005. Epub 2015 Mar 27.

  PMID: 26008940 BACKGROUND

• Duddy M, Lee M, Pearson O, Nikfekr E, Chaudhuri A, Percival F, Roberts M, Whitlock C. The UK patient experience of relapse in Multiple Sclerosis treated with first disease modifying therapies. Mult Scler Relat Disord. 2014 Jul;3(4):450-6. doi: 10.1016/j.msard.2014.02.006. Epub 2014 Mar 4.

  PMID: 25877056 BACKGROUND

• National Clinical Guideline Centre (UK). Multiple Sclerosis: Management of Multiple Sclerosis in Primary and Secondary Care. London: National Institute for Health and Care Excellence (UK); 2014 Oct. Available from http://www.ncbi.nlm.nih.gov/books/NBK248064/

  PMID: 25340249 BACKGROUND

• Caspersen CJ, Powell KE, Christenson GM. Physical activity, exercise, and physical fitness: definitions and distinctions for health-related research. Public Health Rep. 1985 Mar-Apr;100(2):126-31.

  PMID: 3920711 BACKGROUND

• Overs S, Hughes CM, Haselkorn JK, Turner AP. Modifiable comorbidities and disability in multiple sclerosis. Curr Neurol Neurosci Rep. 2012 Oct;12(5):610-7. doi: 10.1007/s11910-012-0293-4.

  PMID: 22791240 BACKGROUND

• White LJ, Dressendorfer RH. Exercise and multiple sclerosis. Sports Med. 2004;34(15):1077-100. doi: 10.2165/00007256-200434150-00005.

  PMID: 15575796 BACKGROUND

• Giovannoni G, Butzkueven H, Dhib-Jalbut S, Hobart J, Kobelt G, Pepper G, Sormani MP, Thalheim C, Traboulsee A, Vollmer T. Brain health: time matters in multiple sclerosis. Mult Scler Relat Disord. 2016 Sep;9 Suppl 1:S5-S48. doi: 10.1016/j.msard.2016.07.003. Epub 2016 Jul 7.

  PMID: 27640924 BACKGROUND

• Sandroff BM, Dlugonski D, Weikert M, Suh Y, Balantrapu S, Motl RW. Physical activity and multiple sclerosis: new insights regarding inactivity. Acta Neurol Scand. 2012 Oct;126(4):256-62. doi: 10.1111/j.1600-0404.2011.01634.x. Epub 2012 Jan 3.

  PMID: 22211941 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

• Learmonth YC, Motl RW. Physical activity and exercise training in multiple sclerosis: a review and content analysis of qualitative research identifying perceived determinants and consequences. Disabil Rehabil. 2016;38(13):1227-42. doi: 10.3109/09638288.2015.1077397. Epub 2015 Aug 28.

  PMID: 26314587 BACKGROUND

• Wilkinson, H. R. and das Nair, R. (2013), 'The psychological impact of the unpredictability of multiple sclerosis: a qualitative literature meta-synthesis', British Journal of Neuroscience Nursing, 9 (4), pp. 172-178

  BACKGROUND

• Learmonth YC, Adamson BC, Balto JM, Chiu CY, Molina-Guzman I, Finlayson M, Riskin BJ, Motl RW. Multiple sclerosis patients need and want information on exercise promotion from healthcare providers: a qualitative study. Health Expect. 2017 Aug;20(4):574-583. doi: 10.1111/hex.12482. Epub 2016 Jul 20.

  PMID: 27436592 BACKGROUND

• Kjolhede T, Vissing K, Dalgas U. Multiple sclerosis and progressive resistance training: a systematic review. Mult Scler. 2012 Sep;18(9):1215-28. doi: 10.1177/1352458512437418. Epub 2012 Apr 24.

  PMID: 22760230 BACKGROUND

• Platta ME, Ensari I, Motl RW, Pilutti LA. Effect of Exercise Training on Fitness in Multiple Sclerosis: A Meta-Analysis. Arch Phys Med Rehabil. 2016 Sep;97(9):1564-1572. doi: 10.1016/j.apmr.2016.01.023. Epub 2016 Feb 16.

  PMID: 26896750 BACKGROUND

• Tallner A, Waschbisch A, Wenny I, Schwab S, Hentschke C, Pfeifer K, Maurer M. Multiple sclerosis relapses are not associated with exercise. Mult Scler. 2012 Feb;18(2):232-5. doi: 10.1177/1352458511415143. Epub 2011 Jul 6.

  PMID: 21733890 BACKGROUND

• Pilutti LA, Platta ME, Motl RW, Latimer-Cheung AE. The safety of exercise training in multiple sclerosis: a systematic review. J Neurol Sci. 2014 Aug 15;343(1-2):3-7. doi: 10.1016/j.jns.2014.05.016. Epub 2014 May 15.

  PMID: 24880538 BACKGROUND

• Bjarnadottir OH, Konradsdottir AD, Reynisdottir K, Olafsson E. Multiple sclerosis and brief moderate exercise. A randomised study. Mult Scler. 2007 Jul;13(6):776-82. doi: 10.1177/1352458506073780. Epub 2007 Mar 15.

  PMID: 17613606 BACKGROUND

• Briken S, Gold SM, Patra S, Vettorazzi E, Harbs D, Tallner A, Ketels G, Schulz KH, Heesen C. Effects of exercise on fitness and cognition in progressive MS: a randomized, controlled pilot trial. Mult Scler. 2014 Mar;20(3):382-90. doi: 10.1177/1352458513507358. Epub 2013 Oct 24.

  PMID: 24158978 BACKGROUND

• Dalgas U, Stenager E, Jakobsen J, Petersen T, Overgaard K, Ingemann-Hansen T. Muscle fiber size increases following resistance training in multiple sclerosis. Mult Scler. 2010 Nov;16(11):1367-76. doi: 10.1177/1352458510377222. Epub 2010 Aug 4.

  PMID: 20685760 BACKGROUND

• Craig J, Young CA, Ennis M, Baker G, Boggild M. A randomised controlled trial comparing rehabilitation against standard therapy in multiple sclerosis patients receiving intravenous steroid treatment. J Neurol Neurosurg Psychiatry. 2003 Sep;74(9):1225-30. doi: 10.1136/jnnp.74.9.1225.

  PMID: 12933923 BACKGROUND

• Nedeljkovic U, Dackovic J, Tepavcevic DK, Basuroski ID, Mesaros S, Pekmezovic T, Drulovic J. Multidisciplinary rehabilitation and steroids in the management of multiple sclerosis relapses: a randomized controlled trial. Arch Med Sci. 2016 Apr 1;12(2):380-9. doi: 10.5114/aoms.2015.47289. Epub 2015 Mar 18.

  PMID: 27186184 BACKGROUND

• Motl RW, Learmonth YC, Pilutti LA, Gappmaier E, Coote S. Top 10 research questions related to physical activity and multiple sclerosis. Res Q Exerc Sport. 2015 Jun;86(2):117-29. doi: 10.1080/02701367.2015.1023099. Epub 2015 Apr 15.

  PMID: 25874730 BACKGROUND

• Adamson, B. C., Adamson, M. D., Littlefield, M. M. and Motl, R. W. (2017) 'Move it or lose it: perceptions of the impact of physical activity on multiple sclerosis symptoms, relapse and disability identity', Qualitative Research in Sport, Exercise and Health

  BACKGROUND

• Overcoming MS (2018) Overcoming MS Forum [Online]. Available at: https://overcomingms.org/forum/viewtopic.php?f=5&t=1214 (Accessed 11 October 2017).

  BACKGROUND

• Shift MS (2018) Shift MS Forum [Online]. Available at: https://shift.ms/forums/topic/physical-activity-after-a-relapse#post-110842 (Accessed 11 April 2018).

  BACKGROUND

• MS Society (2017) MS Society Forum [Online]. Available at: https://community.mssociety.org.uk/forums/everyday-living/physical-activity-or-exercise-after-relapse#comment (Accessed 10 April 2018).

  BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity; Recurrence

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Caroline McGraw, PhD

  City, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 9, 2018
• Study Start: November 13, 2018
• Primary Completion: May 14, 2019
• Study Completion: September 30, 2019
• Last Updated: December 18, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)