Cognitive Reserve-building Activities in Multiple Sclerosis: a Randomized Controlled Trial of the Effect of Cognitive Leisure Activities on Objective and Subjective Measures of Cognition
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in score on the Symbol Digit Modality Test (SDMT)
研究概览
简要总结
The study is a crossover randomized controlled trial investigating the effect of increasing engagement in cognitive leisure activities for individuals with multiple sclerosis.
详细描述
The study is a crossover randomized controlled trial investigating the impact of cognitive leisure activities on the cognitive functioning of individuals with multiple sclerosis (MS). The goal is to investigate whether increasing leisure activities may help prevent cognitive impairment in individuals with MS.
The trial consists of two studies. The first is a randomized controlled trial examining the effects of increasing engagement in cognitive leisure activities. The second is a qualitative interview-based study to identify factors that may improve adherence and acceptance of the intervention. The study employs a randomized, controlled crossover design, with 60 participants (30 with relapsing-remitting MS, 30 with progressive MS) assigned to either an intervention group or a passive control group for 12 weeks. After the initial 12 weeks the groups are crossed over and followed up after an additional 12 weeks. The intervention group will receive instruction and support to engage in cognitive leisure activities, while the control group will continue with their usual daily activities.
For a detailed description of the project, the full protocol can be found at:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded as to the participant's assigned intervention.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RRMS, SPMS or PPMS
- •Age 18-65
- •EDSS score ≤ 6.5
- •SDMT (or PASAT) score below -1 SD
- •No depression based on the MDI
- •Able to use computer or smartphone and has internet access
- •If in treatment with one or more of the following medications, the dosage must be stable:
- •Cannabinoids
- •Anticholinergic medications
- •Sedatives e.g., benzodiazepines
- •Antispasmodics
- •Beta-blockers
- •Antidepressant medication
- •Fampridine
排除标准
- •Planned start-up or discontinuation of one or more of the above-mentioned medications
- •Structural brain changes following previous head trauma or neurological conditions other than which lead to structural changes or affect cognitive abilities
- •Significant psychiatric co-morbidity
- •Significant somatic co-morbidity including, but not limited to, severe cardiovascular disease as well as liver, kidney, and endocrine diseases
- •Relapse 3 months prior to inclusion
研究组 & 干预措施
Cognitive Leisure Activities
Participants in the intervention group will engage in cognitive leisure activities for 12 weeks and will be instructed to track their daily activity level in minutes through a daily online questionnaire. To maintain motivation and improve adherence to the study protocol, participants will also receive regular follow-up phone calls from a member of the research team every 2 weeks.
After the initial 12 weeks, the groups will be crossed over and the study will continue for another 12 weeks.
干预措施: Cognitive Leisure Activities (Behavioral)
Passive control
Participants in the passive control group will not receive information regarding the intervention and cognitive leisure activities. They will instead be instructed to carry on as usual and to expect active participation in the study in 12 weeks from the time of enrolment.
结局指标
主要结局
Change in score on the Symbol Digit Modality Test (SDMT)
时间窗: Baseline, week 12, week 24
An objective measure of cognitive efficiency
Change in score on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ)
时间窗: Baseline, week 12, week 24
A subjective measure of cognitive symptoms for patients with MS
次要结局
- Change in score on the California Verbal Learning Test II (CVLT II)(Baseline, week 12, week 24)
- Change in score on the Brief Visuospatial Memory Test Revised (BVMT-R)(Baseline, week 12, week 24)
- Change in score on the Cognitive Leisure and Activity Scale (CLAS)(Baseline, week 12, week 24, week 36)
- Change in score on the Word Fluency Test (phonological)(Baseline, week 12, week 24)
- Change in score on the Five-point Test(Baseline, week 12, week 24)
研究者
Andreas Kirknæs Færk
Neuropsychologist, PhD student
Rigshospitalet, Denmark