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临床试验/NCT03244696
NCT03244696已完成不适用

Behavior and Activity Monitoring in Multiple Sclerosis

Ohio State University2 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2017年11月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
87
试验地点
2
主要终点
Change in Cognitive Performance on a Latent Measure of Working Memory/Processing Speed

研究概览

简要总结

The investigators propose to conduct a randomized 6-month intervention study comparing cognitive functioning in individuals with relapsing-remitting multiple sclerosis assigned to either a physical activity or an active water-intake control group. Individuals will complete pre-, mid- and post-assessments of cognitive, physical, and behavioral functioning.

详细描述

Interventions to increase physical activity through aerobic exercise are some of the only known treatment options to improve domains of cognition such as executive function. While increased physical activity is associated with preserved cortical functioning during exogenous executive functioning tasks in older adults, little is known about the relationship between physical activity and executive functioning in multiple sclerosis. Thus, the investigators propose to conduct a randomized 6-month accelerometry-based intervention designed to increase overall physical activity in sedentary relapsing-remitting multiple sclerosis with known cognitive challenges. The overall objective is to determine how a 6-month activity tracking intervention impacts the behavioral, neural and mechanistic associations between physical activity and cognitive functioning. All individuals who contact the Clinical Neuroscience Laboratory (CNL) with interest in this study will undergo a phone/online screening assessing inclusion/exclusion criteria. Those participants meeting I/E criteria will be invited to the lab for 2 pre-assessment sessions, one session at midpoint, and 2 post-assessment sessions at the completion of the 6 month intervention. Participants will also be asked to complete a number of online questionnaires following the first assessment session. The two pre-assessments will involve a through measure of cognitive functioning, both through the use of neuropsychological batteries and neuroimaging, and inflammatory markers through collection of a blood sample. Following the pre-assessment sessions, conducted by blind personnel, participants will be randomized to one of the two groups. Participants will be asked to self-monitor their assigned health behavior with the aid of a behavioral tracker (accelerometer or smart water bottle). Via a mobile application designed by the laboratory, participants will receive daily and weekly summaries of their health behavior progress, and motivational materials to encourage goal attainment. The 6-month intervention will involve minimal contact from study coordinators. Participants who do not adhere to study goals will be contacted by a study coordinator via phone who will use motivational interviewing to promote behavior change. Following the 6-month intervention the 2 assessment sessions will be repeated to obtain post-intervention data for comparison.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
30 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Clinically definite diagnosis of Relapsing-Remitting Multiple Sclerosis
  • Score higher than 23 on the Mini-Mental Status Examination (MMSE)
  • Expanded Disability Status Scale (EDSS) under 5.5
  • Right-handed

排除标准

  • Clinically isolated syndrome or progressive MS subtype
  • Presence of any other neurological disorders
  • Presence of psychiatric disorder diagnosed by a licensed mental health provider in the last two years
  • Clinically definite relapse or use of high dose corticosteroids within the last 30 days
  • Recreational drug use in the last 6 months
  • Without access to a smart phone or no access to the internet
  • Current use of accelerometer, pedometer, and/or physical activity monitoring equipment
  • Presence of ferromagnetic implanted devices or self-reported claustrophobia

结局指标

主要结局

Change in Cognitive Performance on a Latent Measure of Working Memory/Processing Speed

时间窗: Baseline, 3 months, and 6 months

Change in a latent factor of working memory/processing speed will be examined from pre to post intervention. This latent factor will be created using baseline performance on measures from the Minimal Assessment of Cognitive Functioning in Multiple Sclerosis battery (MACFIMS), the NIH Toolbox Cognition Battery (NIHTB-CB), and the processing speed and working memory measures from the Wechsler Adult Intelligence Scale (WAIS-IV) before, during (at midpoint), and after the intervention. Higher scores on this factor represent better working memory/processing speed performance. Investigators hypothesize changes in cognitive performance, specifically in the domains of working memory and processing speed.

次要结局

  • Changes on a Self-Report Measure of Quality of Life(Baseline, 3 months and 6 months)
  • Changes in the Functional Architecture of the MS Brain during Working Memory(Baseline and 6 months)
  • Changes in the Functional Architecture of the MS Brain during Processing Speed(Baseline and 6 months)
  • Changes on a Self-Report Measure of Depression(Baseline, 3 months, and 6 months)
  • Changes on a Self-Report Measure of Anxiety(Baseline, 3 months and 6 months)
  • Changes on a Self-Report Measure of Perceived Stress(Baseline, 3 months and 6 months)
  • Changes on a Self-Report Measure of Sleep Quality(Baseline, 3 months and 6 months)
  • Changes on a Self-Report Measure of Fatigue(Baseline, 3 months and 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ruchika Prakash

Ruchika Prakash, Associate Professor

Ohio State University

研究点 (2)

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