Multiple SclerosisMStepNCT01611987
The Role of Exercise in Modifying Outcomes for People With Multiple Sclerosis
A study testing MStep and General guideline approach in people with Multiple Sclerosis, run by McGill University at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- MStep and General guideline approach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 5 sitesCanada
- Study dates
- Sep 2012to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Canada5 sites
CHUM
Montreal, Quebec
Muhc - Mnh
Montreal, Quebec
Sunnybrook Hospital
Toronto, Ontario, M4N 3M5
St. Michael's Hospital
Toronto, Ontario
Toronto Rehabiliation Institute
Toronto, Ontario
About this study
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- MStep, General guideline approach
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MStepOther
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.
General guideline approachOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: General guideline approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen consumption
VO2peak will be determined using an incremental graded cycle ergometer test. Greater oxygen consumption implies in better exercise capacity
Measured: 3 timepoints: baseline, at 12 monts, at 24 months
Secondary outcomes (11)
muscle strength measured with Biodex
Greater values imply greater muscle strength
Measured: 3 timepoints: Baseline, at 12 months, at 24 months
6 Minute Walk test (6MWT)
Distance walked will be measured with the 6-Minute Walk Test. Greater values imply that a longer distance was covered within 6 minutes
Measured: 5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months
Anaerobic leg power
Greater value indicate greater anaerobic leg power
Measured: 1 timepoint: baseline
Patient Determined Disease Steps (PDDS)
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.
Measured: 5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months
Change in fatigue levels
Fatigue will be measured with a single item question asking them the number of days that they felt certain levels of fatigue.
Measured: 5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months
Rand 36
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.
Measured: 5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months
EQ-5D
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
Measured: 5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months
Patient generated Index
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.
Measured: 5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months
Exercise Self-Efficacy Scale
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).
Measured: 5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months
Change in perception about exercise benefits and exercise barrier
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"
Measured: 5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months
Modified Canadian Aerobic Fitness test
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
Measured: 3 timepoints: 3 month, 6 month and 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Mayo, McGill University
- Investigators
- Nancy E Mayo, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611987
- Sponsor's protocol ID
- CIHR258309
- Acronym
- MStep
- Status last verified
- Apr 2017
- First submitted
- 22 May 2012
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 8414027Warren 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.
PubMed 12566957Turner 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.
PubMed 19254606Poppe 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.
PubMed 19235443White 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.
PubMed 18201113White 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.
PubMed 18278981Dalgas 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.
PubMed 17881393Mayo N. Setting the agenda for multiple sclerosis rehabilitation research. Mult Scler. 2008 Nov;14(9):1154-6. doi: 10.1177/1352458508096567. No abstract available.
PubMed 18952830Motl 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.
PubMed 17131278Motl 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 16042230Rietberg 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.
PubMed 15674920Asano 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.
PubMed 19324979Dalgas 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.
PubMed 19884575Hayes 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.
PubMed 21475078Mayo 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.
PubMed 23809312
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Exercise in Modifying Outcomes for People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01611987
- Acronym / sponsor ID
- MStep / CIHR258309
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 5 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSTEP | Experimental | Other: MStepThe 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. |
| General guideline approach | Active comparator | Other: General guideline approachThe general Guideline approach is the general guidelines that are recommended for people with MS by the Canadian Society Exercise Physiology. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| MStepParticipant 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. | Other | MSTEP |
| General guideline approachIndividuals 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. | Other | General guideline approach |
Primary outcome
oxygen consumption
Time frame: 3 timepoints: baseline, at 12 monts, at 24 months
VO2peak will be determined using an incremental graded cycle ergometer test. Greater oxygen consumption implies in better exercise capacity
11 secondary outcomes
muscle strength measured with Biodex
Time frame: 3 timepoints: Baseline, at 12 months, at 24 months
6 Minute Walk test (6MWT)
Time frame: 5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months
Anaerobic leg power
Time frame: 1 timepoint: baseline
Patient Determined Disease Steps (PDDS)
Time frame: 5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months
Change in fatigue levels
Time frame: 5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months
Rand 36
Time frame: 5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months
EQ-5D
Time frame: 5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months
Patient generated Index
Time frame: 5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months
Exercise Self-Efficacy Scale
Time frame: 5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months
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
Modified Canadian Aerobic Fitness test
Time frame: 3 timepoints: 3 month, 6 month and 18 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Background: PubMed 8414027Warren 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.
- Background: PubMed 12566957Warren 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.
- Background: PubMed 19254606Turner 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.
- Background: PubMed 19235443Poppe 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.
- Background: PubMed 18201113White 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.
- Background: PubMed 18278981White 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.
- Background: PubMed 17881393Dalgas 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.
- Background: PubMed 18952830Mayo N. Setting the agenda for multiple sclerosis rehabilitation research. Mult Scler. 2008 Nov;14(9):1154-6. doi: 10.1177/1352458508096567. No abstract available.
- Background: PubMed 17131278Motl 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.
- 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 15674920Rietberg 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.
- Background: PubMed 19324979Asano 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.
- Multiple Sclerosis Society of CanadaLink provided by the sponsor.
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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.
Nancy E Mayo, PhD principal investigator
McGill University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MStep and General guideline approach in people with Multiple Sclerosis, run by McGill University at 5 sites in Canada.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. 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?
Results are not available in the source record.
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?
oxygen consumption (time frame: 3 timepoints: baseline, at 12 monts, at 24 months). 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 NCT01611987, which also lists 15 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 26 Apr 2017.