跳至主要内容
临床试验/NCT01070459
NCT01070459Unknown3 期

The Effect of an Aerobic Training Programme on the Aerobic Capacity, Functional Behavior and the Cardiovascular Risk Factors in Stroke Patients

University College of Antwerp2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年2月1日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
50
试验地点
2
主要终点
VO2-peak, strength, walking, activities of daily living

研究概览

简要总结

This study aims to investigate the effect of aerobic exercise on the aerobic capacity, the daily functioning, post-stroke fatigue , depression and cardiovascular risk factors in stroke patients.

详细描述

People with neurologic impairments after stroke often show decreased aerobic exercise capacity. The etiologies of which are assigned to physiologic changes in paretic muscle, gait deficits and disability-related deconditioning. This declares that stroke patients live an inactive lifestyle and therefore stay cardiovascular risk patients.

The usefulness of aerobic training on aerobic capacity is recently been proved in clinical stroke research. However, no study can shown the long-term effect of aerobic exercises. Also the effect of aerobic exercises on daily functioning, fatigue and depression in stroke needs to be established.

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, Investigator)

入排标准

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

入选标准

  • First CVA according to the WHO definition (A primary, first ever stroke ash revealed by rapidly developing clinical signs or focal or global disturbance or cerebral function, with symptoms lasting 24 hours or longer or leading to death, with no apparent cause other than or vascular origin.) This includes ischemic infarct or an intracerebral haemorrhage
  • The offense can be maximum 3 up to 6 weeks after onset
  • Patient must be able to follow simple verbal instructions
  • To cycle during 1 minute at 20 Watt, 50RPM,
  • Cardiac stable

排除标准

  • Have another neurological impairments with permanent damage such as former cranial trauma, multiple sclerosis, epileptic status... which already present were for current CVA
  • Having on CVA resembling symptoms as a result of subdural haemorrhage, a tumour, encephalitis or a trauma
  • Barthel index < 50 before the stroke onset
  • Age > 80 year
  • No authorisation form of the patient or of the family
  • Absolute contra-indications for effort test (ACC/AHA guidelines)

结局指标

主要结局

VO2-peak, strength, walking, activities of daily living

时间窗: baseline , after 12 weeks training. Follow-up measurements after 6 months, 1 and 2 years after baseline.

次要结局

  • post-stroke fatigue, depression, lifestyle, cardiovascular risk factors(baseline , after 12 weeks training. Follow-up measurements after 6 months, 1 and 2 years after baseline.)

研究者

发起方
University College of Antwerp
申办方类型
Other

研究点 (2)

Loading locations...

相似试验

The Effect of an Aerobic Exercise Programme in... | 临床试验