The Role of Exercise in Modifying Outcomes for People With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 5
- 主要终点
- oxygen consumption
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: MStep (Other)
General guideline approach
The general Guideline approach is the general guidelines that are recommended for people with MS by the Canadian Society Exercise Physiology.
干预措施: General guideline approach (Other)
结局指标
主要结局
oxygen consumption
时间窗: 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
次要结局
- Anaerobic leg power(1 timepoint: baseline)
- 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)
- Rand 36(5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months)
- EQ-5D(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(5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months)
- 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)
- Modified Canadian Aerobic Fitness test(3 timepoints: 3 month, 6 month and 18 month)
- Patient generated Index(5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months)
- Exercise Self-Efficacy Scale(5 timepoints: at baseline, at 6 months, at 12 months, at 18 months, at 24 months)
研究者
Nancy Mayo
PhD, Principal Investigator
McGill University