Improving Cognition in People With Progressive Multiple Sclerosis: A Multi-Arm, Randomized, Blinded, Sham-Controlled Trial of Cognitive Rehabilitation and Aerobic Exercise.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 309
- 试验地点
- 1
- 主要终点
- Change from baseline cognitive Information processing speed at 12 weeks and 6 months
研究概览
简要总结
Given that up to 70% of people with secondary progressive MS are cognitively impaired, the search for effective treatments is considered a priority by people living with the disease. This proposal will address the effectiveness of cognitive rehabilitation (CR) and exercise, either alone, or in combination in this regard. A team of MS researchers has been assembled from the USA, Canada, the United Kingdom, Italy, Denmark, Germany and Belgium for this. A total of 360 people with progressive MS will make up the sample. Brain MRIs will be undertaken in a third of the sample before and after the 12 weeks of treatment to document the functional changes that are expected to occur with symptom improvement.
详细描述
Aim: The broad aim of this proposal is to evaluate a multidisciplinary and multi-modal approach to rehabilitation in people with progressive MS. Cognitive rehabilitation and aerobic exercise will be evaluated individually and in combinations to address cognitive dysfunction as the primary outcome variable.
Over 20 years have passed since the introduction of the first disease modifying treatment, interferon beta-1betaseron (b), for multiple sclerosis (MS).Since then 13 treatments have been approved and made it onto the market. All are for relapsing-remitting disease (RRMS), apart from mitoxantrone which is limited to progressive disease with relapses, Interferon-beta-1b, which is for secondary progressive disease (SPMS), but does not delay disability progression and Ocrelizumab for primary progressive MS only. Thus, for a sizeable proportion of people with MS there is no therapeutic option to slow progression. This raises the question, how are patients with primary and secondary progressive MS (PPMS and SPMS) to be helped? While research is underway to find a medication that holds promise of halting further deterioration in a disease that has already entered a progressive stage, patients and their clinicians are left with basically symptomatic treatments.
Hypothesis
The investigators hypothesize that CR and aerobic exercise are effective treatments for cognitive impairment (processing speed deficits) in people with progressive MS. In particular a combination of these two treatment given twice weekly over 12 weeks is more effective than each individual treatment given alone or as sham. The investigators further hypothesize that improvements in processing speed will be matched on functional MRI (fMRI) by enhanced neural activity in networks associated with information processing speed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
In order to prevent bias in our research results, we will employ a double-blind study design in which the examiner nor the research participant will know which group membership they were assigned to.
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a confirmed diagnosis of progressive Multiple Sclerosis
- •Visual Acuity of 20/70
- •Language comprehension, to ensure subjects have the ability to understand instructions
排除标准
- •Wheelchair dependent (EDSS > 7.0)
- •History of central nervous system disease other than progressive MS
- •Steroids use within the past 3 months
- •Regular aerobic training (eg. bi-cycling, running, swimming or rowing)
- •Unwilling to travel to study sites for rehabilitation 2 times a week for 3 months
研究组 & 干预措施
Cognitive Rehab & Sham Exercise
Cognitive Rehabilitation by computer based brain tasks, and Sham exercises focusing primary on balance and stretching. Sessions will take place twice a week for 12 weeks.
干预措施: Cognitive Rehabilitation (Other)
Cognitive Rehab & Sham Exercise
Cognitive Rehabilitation by computer based brain tasks, and Sham exercises focusing primary on balance and stretching. Sessions will take place twice a week for 12 weeks.
干预措施: Sham Exercise (Other)
Sham Cognitive Rehab & Sham Exercise
Sham cognitive Rehabilitation will consist of basic internet searches and learning to use a computer, and sham exercises focusing primary on balance and stretching. Sessions will take place twice a week for 12 weeks.
干预措施: Sham Exercise (Other)
Sham Cognitive Rehab & Sham Exercise
Sham cognitive Rehabilitation will consist of basic internet searches and learning to use a computer, and sham exercises focusing primary on balance and stretching. Sessions will take place twice a week for 12 weeks.
干预措施: Sham Cognitive Rehabilitation (Other)
Sham Cognitive rehab & Aerobic Exercise
Sham cognitive rehabilitation will consist of basic internet searches and learning to use a computer, and aerobic exercises will focus primarily on improving cardio-respiratory fitness using a recumbent bike. Sessions will take place twice a week for 12 weeks.
干预措施: Sham Cognitive Rehabilitation (Other)
Sham Cognitive rehab & Aerobic Exercise
Sham cognitive rehabilitation will consist of basic internet searches and learning to use a computer, and aerobic exercises will focus primarily on improving cardio-respiratory fitness using a recumbent bike. Sessions will take place twice a week for 12 weeks.
干预措施: Aerobic Exercise (Other)
Cognitive Rehab & Aerobic Exercise
Cognitive Rehabilitation by computer based brain tasks and aerobic exercises will focus primarily on improving cardio-respiratory fitness using a recumbent bike. Sessions will take place twice a week for 12 weeks.
干预措施: Cognitive Rehabilitation (Other)
Cognitive Rehab & Aerobic Exercise
Cognitive Rehabilitation by computer based brain tasks and aerobic exercises will focus primarily on improving cardio-respiratory fitness using a recumbent bike. Sessions will take place twice a week for 12 weeks.
干预措施: Aerobic Exercise (Other)
结局指标
主要结局
Change from baseline cognitive Information processing speed at 12 weeks and 6 months
时间窗: Baseline, 12 weeks, and 6 month
The Symbol Digit Modalities Test (SDMT) will be used to measure cognitive information processing speed The SDMT is a simple matching task that requires the participant to refer to a reference key, in order to correctly match a geometric symbol with the corresponding number. Participant will be under a 90 second time constraint to quickly and correctly match each pair. Test will be administered at index assessment, 12 weeks following cognitive rehab/ aerobic exercise, and at 6 months to examine cognitive retention
次要结局
- Change from baseline fatigue, at 12 weeks and 6 months(Baseline, 12 weeks, and 6 month)
- Change from baseline perceived deficits, at 12 weeks and 6 months(Baseline, 12 weeks, and 6 month)
- Change from baseline depression, at 12 weeks and 6 months(Baseline, 12 weeks, and 6 month)
- Change from baseline global function, at 12 weeks and 6 months(Baseline, 12 weeks, and 6 month)
- Change from baseline cognitive visual memory at 12 weeks and 6 months(Baseline, 12 weeks, & 6 month)
- Change from baseline impact of Multiple Sclerosis, at 12 weeks and 6 months(Baseline, 12 weeks, and 6 month)
- Change from baseline cognitive verbal memory at 12 weeks and 6 months(Baseline, 12 weeks, & 6 month)
- Change from baseline anxiety & depression, at 12 weeks and 6 months(Baseline, 12 weeks, and 6 month)
- Change from baseline quality of life, at 12 weeks and 6 months(Baseline, 12 weeks, and 6 month)
- Change from baseline subjective impact of walking, at 12 weeks and 6 months(Baseline, 12 weeks, and 6 month)
研究者
Dr. Anthony Feinstein
Professor, department of psychiatry, University of Toronto
Sunnybrook Health Sciences Centre