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临床试验/NCT01783665
NCT01783665已完成不适用

The Effect of Aerobic Exercise on Cognitive Function and Sleep Quality in Individuals With Multiple Sclerosis

Catherine Siengsukon, PT, PhD1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2012年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
28
试验地点
1
主要终点
Change in Cognitive Function

研究概览

简要总结

In addition to the typical motor and sensory impairments, individuals with multiple sclerosis (MS) often experience cognitive dysfunction and sleep disturbances. Cognitive impairment occurs in 40 % - 70% of patients with MS. In addition, sleep problems in individuals with MS are very common, and approximately 50% of patients with MS have a diagnosable sleep disorder. The research believes that aerobic exercise improve cognitive function and improve sleep quality.

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
None

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •diagnosis of relapsing remitting or secondary progressive MS
  • •score 3-7 on the EDSS
  • •score < 55 on the Symbol Digit Modalities Test
  • •score > 5 on the Pittsburgh Sleep Quality Index

排除标准

  • •history of alcohol/drug abuse or nervous system disorder other than MS
  • •severe physical, neurological, or sensory impairments that would interfere significantly with testing
  • •developmental history of learning disability or attention-deficit/hyperactivity disorder
  • •relapse and/or corticosteroid use within four weeks of assessment
  • •unable to give consent
  • •uncorrected vision loss that would interfere significantly with testing
  • •score less than 24 on MMSE
  • •Acute ischemic cardiovascular event or coronary artery bypass surgery less than 3 months ago
  • •Either unable to physically perform the exercise test using the recumbent stepper or demonstrate absolute indications for terminating exercise that follows the American College of Sports Medicine's (ACSM) guidelines
  • •Uncontrolled blood pressure with medication (BP > 190/110mmHg)

研究组 & 干预措施

Home exercise program

Active Comparator

Walking and stretching exercises performed 3x/week for 30 minutes at intensity considered non-aerobic

干预措施: home exercise program (Other)

Aerobic Exercise

Experimental

3x/week supervised moderate intensity aerobic exercise on recumbent stepper

干预措施: aerobic exercise (Other)

结局指标

主要结局

Change in Cognitive Function

时间窗: Baseline to Month 3

次要结局

  • Change in Sleep Quality(Baseline to Month 3)

研究者

发起方
Catherine Siengsukon, PT, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Catherine Siengsukon, PT, PhD

Assistant Professor

University of Kansas Medical Center

研究点 (1)

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