The Role of Exercise in Modifying Outcomes for People With Multiple Sclerosis

NCT01611987 | Unknown

• 1 other identifier: CIHR258309
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 5

Brief Summary

Despite the benefits of exercise and physical activity people with Multiple Sclerosis (MS) are relatively inactive. Physical activity is important for persons with disabilities to maintain physical function. A lack of physical activity can contribute to heart disease, osteoporosis, obesity, and diabetes. At the moment, the best way for people with MS to exercise and be physical activity is unknown. People with MS report not knowing what to do. This is a barrier to exercise. The global aim of this study is to contribute evidence for the role of targeted exercise in altering MS outcomes over time. The design is a randomized controlled trial (RCT). The primary research question is to what extent does an MS Tailored Exercise Program (MSTEP) result in greater improvements in exercise capacity and related outcomes in comparison to a program based on general guidelines for exercise among people with MS who are sedentary and wish to engage in exercise as part of MS self-management. The primary outcome for this question is exercise capacity measured using cycle ergometry. However exercise efficiency, functional ambulation, strength, components of quality of life including frequency and intensity of fatigue symptoms, mood, global physical function, health perception, and illness intrusiveness, will also be measured as components of a global response outcome. The first confirmatory hypothesis is that MSTEP will result in a greater proportion of people making clinically relevant gains (at least 10% change) in exercise capacity than with general guidelines after 12 months of intervention; a secondary hypothesis is that, while there may be some decline in exercise capacity among individuals from end of intervention to follow-up one year later, the decline will be greater in the general guideline group augmenting the difference between groups in the proportion making 10% change from study entry to 24 months. In other words, gains will be maintained more for the MSTEP group over the general guideline group. An exploratory hypothesis is that more of the targeted outcomes will improve with the MSTEP program than the general guideline approach. An explanatory hypothesis is that these gains will be accompanied by reports of greater exercise enjoyment and exercise self-efficacy (confidence) with the MSTEP program than with the general guideline program leading to more consistent exercise engagement and improved long-term adherence.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• oxygen consumption

  VO2peak will be determined using an incremental graded cycle ergometer test. Greater oxygen consumption implies in better exercise capacity

  3 timepoints: baseline, at 12 monts, at 24 months

Secondary Outcomes (11)

• muscle strength measured with Biodex

  3 timepoints: Baseline, at 12 months, at 24 months

• 6 Minute Walk test (6MWT)

  5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months

• Anaerobic leg power

  1 timepoint: baseline

• Patient Determined Disease Steps (PDDS)

  5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months

• Change in fatigue levels

  5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months

Study Arms (2)

MSTEP

EXPERIMENTAL

The MSTEP program is a 6 day tailored exercise program. It includes flexibility, aerobic, peripheral strengthening, core and balance training, power and speed training and push days.

Other: MStep

General guideline approach

ACTIVE COMPARATOR

The general Guideline approach is the general guidelines that are recommended for people with MS by the Canadian Society Exercise Physiology.

Other: General guideline approach

Interventions

MStep OTHER

Participant will meet with instructor twice to learn how to exercise safely. Exercises will be demonstrated and practiced under the direct supervision of the instructor. Written details and pictures will be made. Variety in exercise will be encouraged to promote long-term adherence. Stretching, strengthening and relaxation exercises will be given. Persons will be given Thera Band® to facilitate resistance exercise training and instructed how to progress. Equipment such as Nordic Walking Poles, stationary bicycle, BOSU®, or exercise balls will be available. Rather than having a fixed rigid prescription, the aim is to get people to intuitively adjust the amount of resistance so they feel they are working without causing harm, they are not doing the same boring activity, week in week out.

MSTEP

General guideline approach OTHER

Individuals in the control condition will meet with the exercise instructor on two occasions during the first two weeks to review key components of public health guidelines for physical activity and health. In brief, the general guidelines for MS are (i) aerobic and endurance exercise for 30 minutes per session, 3 times per week at an intensity of 60% to 75% of heart rate peak; (ii) weight training for weak muscles, 2 days per week, on non-endurance days, 8 to 15 repetitions per exercise; and (iii) stretching daily with active or passive range of motion exercises, or attendance at Yoga or Tai Chi classes.

General guideline approach

Eligibility Criteria

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

You may qualify if:

• be community dwelling individuals aged 19 -65 who have been diagnosed after 1994 with MS or CIS;
• be able to speak and read English or French;
• be capable of walking 100 meters without a walking aid (EDSS ≤ 5.5), even if they do use an aid for daily activities.

You may not qualify if:

• have an additional illness that restricts their function; and/or
• had suffered at least one relapse during the past 30 days (as defined by Polman) as this may affect physical activity/exercise participation.

Sponsors & Collaborators

• McGill University: lead

Study Sites (5)

Sunnybrook Hospital

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Toronto Rehabiliation Institute

Toronto, Ontario, Canada

Location

CHUM

Montreal, Quebec, Canada

Location

Muhc - Mnh

Montreal, Quebec, Canada

Location

Related Publications (15)

• Warren S, Warren KG. Prevalence, incidence, and characteristics of multiple sclerosis in Westlock County, Alberta, Canada. Neurology. 1993 Sep;43(9):1760-3. doi: 10.1212/wnl.43.9.1760.

  PMID: 8414027 BACKGROUND

• Warren S, Warren KG, Svenson LW, Schopflocher DP, Jones A. Geographic and temporal distribution of mortality rates for multiple sclerosis in Canada, 1965-1994. Neuroepidemiology. 2003 Jan-Feb;22(1):75-81. doi: 10.1159/000067111.

  PMID: 12566957 BACKGROUND

• Turner AP, Kivlahan DR, Haselkorn JK. Exercise and quality of life among people with multiple sclerosis: looking beyond physical functioning to mental health and participation in life. Arch Phys Med Rehabil. 2009 Mar;90(3):420-8. doi: 10.1016/j.apmr.2008.09.558.

  PMID: 19254606 BACKGROUND

• Poppe AY, Wolfson C, Zhu B. Prevalence of multiple sclerosis in Canada: a systematic review. Can J Neurol Sci. 2008 Nov;35(5):593-601. doi: 10.1017/s0317167100009380.

  PMID: 19235443 BACKGROUND

• White LJ, Castellano V. Exercise and brain health--implications for multiple sclerosis: Part 1--neuronal growth factors. Sports Med. 2008;38(2):91-100. doi: 10.2165/00007256-200838020-00001.

  PMID: 18201113 BACKGROUND

• White LJ, Castellano V. Exercise and brain health--implications for multiple sclerosis: Part II--immune factors and stress hormones. Sports Med. 2008;38(3):179-86. doi: 10.2165/00007256-200838030-00001.

  PMID: 18278981 BACKGROUND

• Dalgas U, Stenager E, Ingemann-Hansen T. Multiple sclerosis and physical exercise: recommendations for the application of resistance-, endurance- and combined training. Mult Scler. 2008 Jan;14(1):35-53. doi: 10.1177/1352458507079445. Epub 2007 Sep 19.

  PMID: 17881393 BACKGROUND

• Mayo N. Setting the agenda for multiple sclerosis rehabilitation research. Mult Scler. 2008 Nov;14(9):1154-6. doi: 10.1177/1352458508096567. No abstract available.

  PMID: 18952830 BACKGROUND

• Motl RW, Snook EM, McAuley E, Gliottoni RC. Symptoms, self-efficacy, and physical activity among individuals with multiple sclerosis. Res Nurs Health. 2006 Dec;29(6):597-606. doi: 10.1002/nur.20161.

  PMID: 17131278 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

• Rietberg MB, Brooks D, Uitdehaag BM, Kwakkel G. Exercise therapy for multiple sclerosis. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD003980. doi: 10.1002/14651858.CD003980.pub2.

  PMID: 15674920 BACKGROUND

• Asano M, Dawes DJ, Arafah A, Moriello C, Mayo NE. What does a structured review of the effectiveness of exercise interventions for persons with multiple sclerosis tell us about the challenges of designing trials? Mult Scler. 2009 Apr;15(4):412-21. doi: 10.1177/1352458508101877.

  PMID: 19324979 BACKGROUND

• Dalgas U, Stenager E, Jakobsen J, Petersen T, Hansen HJ, Knudsen C, Overgaard K, Ingemann-Hansen T. Resistance training improves muscle strength and functional capacity in multiple sclerosis. Neurology. 2009 Nov 3;73(18):1478-84. doi: 10.1212/WNL.0b013e3181bf98b4.

  PMID: 19884575 BACKGROUND

• Hayes HA, Gappmaier E, LaStayo PC. Effects of high-intensity resistance training on strength, mobility, balance, and fatigue in individuals with multiple sclerosis: a randomized controlled trial. J Neurol Phys Ther. 2011 Mar;35(1):2-10. doi: 10.1097/NPT.0b013e31820b5a9d.

  PMID: 21475078 BACKGROUND

• Mayo NE, Bayley M, Duquette P, Lapierre Y, Anderson R, Bartlett S. The role of exercise in modifying outcomes for people with multiple sclerosis: a randomized trial. BMC Neurol. 2013 Jun 28;13:69. doi: 10.1186/1471-2377-13-69.

  PMID: 23809312 DERIVED

Related Links

• Multiple Sclerosis Society of Canada

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Nancy E Mayo, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Principal Investigator

Study Record Dates

• First Submitted: May 22, 2012
• First Posted: June 5, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: April 26, 2017

Record last verified: 2017-04

Locations

CA (5)