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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by McGill University
Sponsor:
Information provided by (Responsible Party):
Nancy Mayo, McGill University
ClinicalTrials.gov Identifier:
NCT01611987
First received: May 22, 2012
Last updated: April 26, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Multiple Sclerosis
Other: MStep
Other: General guideline approach

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Exercise in Modifying Outcomes for People With Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by McGill University:

Primary Outcome Measures:
  • oxygen consumption [ Time Frame: 3 timepoints: baseline, at 12 monts, at 24 months ] [ Designated as safety issue: No ]
    VO2peak will be determined using an incremental graded cycle ergometer test. Greater oxygen consumption implies in better exercise capacity


Secondary Outcome Measures:
  • muscle strength measured with Biodex [ Time Frame: 3 timepoints: Baseline, at 12 months, at 24 months ] [ Designated as safety issue: No ]
    Greater values imply greater muscle strength

  • 6 Minute Walk test (6MWT) [ Time Frame: 5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months ] [ Designated as safety issue: No ]
    Distance walked will be measured with the 6-Minute Walk Test. Greater values imply that a longer distance was covered within 6 minutes

  • Anaerobic leg power [ Time Frame: 1 timepoint: baseline ] [ Designated as safety issue: No ]
    Greater value indicate greater anaerobic leg power

  • Patient Determined Disease Steps (PDDS) [ Time Frame: 5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months ] [ Designated as safety issue: No ]
    Patient Determined Disease Steps (PDDS) is a scale focusing mainly on how well someone walk. It ranges from mild symptoms that do not affect physical activity to inability to sit in a wheel chair for more than 1 hour.

  • Change in fatigue levels [ Time Frame: 5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months ] [ Designated as safety issue: No ]
    Fatigue will be measured with a single item question asking them the number of days that they felt certain levels of fatigue.

  • Rand 36 [ Time Frame: 5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months ] [ Designated as safety issue: No ]
    Health status will be measured with the Rand36 Health Status Survey. The Rand36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight.

  • EQ-5D [ Time Frame: 5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months ] [ Designated as safety issue: No ]
    The respondent is asked to indicate his/her health state in each of 5 dimensions. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state.The EQ VAS records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. This information can be used as a quantitative measure of health as judged by the individual respondents

  • Patient generated Index [ Time Frame: 5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months ] [ Designated as safety issue: No ]
    Participants will be asked to identify 5 most important areas of their life that are affected by multiple sclerosis. A second step will be to score how much affected these identified areas were over the past MONTH, in a scale from 1 to 10.

  • Exercise Self-Efficacy Scale [ Time Frame: 5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months ] [ Designated as safety issue: No ]
    This will be measured by the Exercise Self-Efficacy Scale, in which participants are asked how certain they are that they can get to perform an exercise routine regularly (three or more times a week). The scale ranges from 0 (not confident) to 100 (highly confident).

  • Change in perception about exercise benefits and exercise barrier [ Time Frame: 5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months ] [ Designated as safety issue: No ]

    It will be measured with a self-reported questionnaire. For the exercise benefits, the scale range as "strongly disagree, disagree, agree, strongly agree".

    For the exercise barriers the scale range as "sometimes a barrier", "often a barrier"


  • Modified Canadian Aerobic Fitness test [ Time Frame: 3 timepoints: 3 month, 6 month and 18 month ] [ Designated as safety issue: No ]

    mCAFT is a graded step test and can predict VO2peak using a regression equation recently published. Thus, we are confident that we will get usable data for each person and as we are looking for a proportion of people who change over time, persons who do not achieve a peak and have low values on the mCAFT will have a very low value for exercise capacity.

    Greater steps cadence imply on greater oxygen cost



Estimated Enrollment: 240
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MSTEP
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
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.
Active Comparator: General guideline approach
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
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.

Detailed Description:

The proposal is for an assessor-blind, parallel-group, stratified, randomized controlled trial. Potential participants will be identified from the population of persons enrolled in 3 MS clinics in the Montreal area and in 3 clinics in Toronto. All persons who are known to be ambulatory and not to have co-morbidity preventing exercise engagement or capacity to consent will be informed of the study in writing and will be invited for an assessment to determine eligibility for entry into the trial. Those consenting will be randomly assigned to either the MSTEP program or the general exercise guideline program. The intervention period will be one year with follow-up to a second year.

The investigators are targeting a sample size of 120 per group (total 240), which would be sufficient to detect RR of > 1.5 with 80% power. Sample size estimated using pc-size software. The sample size takes into account that drop-outs will inflate the variance of outcomes as multiple imputation will be used to deal with missing data.

The main analysis will be logistic regression to test the main hypothesis related to the superiority of the MSTEP program based on a greater proportion of people making a clinically relevant gain in exercise capacity at 1 year. A secondary outcome will be the differences in proportions at 2 years also using logistic regression. The analysis will be based on intention-to-treat and all persons will be analysed in the groups to which they were randomized.

A secondary analysis will estimate the impact of exercise on the other relevant outcomes. For this approach, each outcome will be converted to a binary response variable based on published clinically meaningful changes and generalized estimating equations (GEE) will be used to test the rate of response in the MSTEP program to the rate of response in the general guideline approach. Multiple outcomes improves the efficiency of the study as the total number of data points is equivalent to the total n multiplied by the number of tests and reduced by the extent to which the outcomes are correlated. Highly correlated outcomes will make the effective sample size smaller than less strongly correlated outcomes. If there is a statistically significant effect of the intervention, then and only then, can the effects of the separate outcomes be interpreted as real.

The results of the trial will be used to develop guidelines for exercise for MS. The investigators are in the process of copyrighting the name of the program (MSTEP). Upon publication of the findings, the description of content will be made available at no cost. If proven effective, a training guide for professionals and patients will be produced most likely taking advantage of the end-of-grant Knowledge Translation (KT) Supplement. Note: The investigators have been funded by the KT supplement to produce a general guide for people with MS, entitled: Getting on with Your Life with MS. The knowledge generated can be used by people with MS and health professional to promote exercise engagement.

  Eligibility

Ages Eligible for Study:   19 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01611987

Contacts
Contact: Carolina Moriello, MSc 5149341934 ext 36926 carolina.moriello@mcgill.ca

Locations
Canada, Ontario
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada
Sunnybrook Hospital Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Toronto Rehabiliation Institute Not yet recruiting
Toronto, Ontario, Canada
Canada, Quebec
CHUM Recruiting
Montreal, Quebec, Canada
Muhc - Mnh Recruiting
Montreal, Quebec, Canada
Sponsors and Collaborators
McGill University
Investigators
Principal Investigator: Nancy E Mayo, PhD McGill University
  More Information

Additional Information:
Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nancy Mayo, PhD, Principal Investigator, McGill University
ClinicalTrials.gov Identifier: NCT01611987     History of Changes
Obsolete Identifiers: NCT01032707
Other Study ID Numbers: CIHR258309
Study First Received: May 22, 2012
Last Updated: April 26, 2013
Health Authority: Canada: Ethics Review Committee
Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014