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临床试验/NCT01521221
NCT01521221Unknown1 期

Assessment of Hand-grip in the Prevention of Postural Orthostatic Hypotension

Tel-Aviv Sourasky Medical Center2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
1 期
入组人数
20
试验地点
2
主要终点
Change in orthostatic blood fall after tilting with and without hand grip.

研究概览

简要总结

The study is aimed to assess the efficacy of hand-grip in preventing orthostatic hypotension in 20 patients diagnosed with autonomic failure. Five healthy subjects will be studied for comparison. The investigators will evaluate the subjects while on tilt table for 10 minutes and than while mounted from lying down to 70 degrees for additional 10 minutes. Blood pressure, heart rate and symptoms will be continuously measured. First study will evaluate the blood pressure changes. Second measure will include hand-grip maneuver 1 minute before the erect positon. Trans cranial Doppler will assess the intracranial blood flow during the position changes.

详细描述

Study 1:

10 minutes lying on the tilt table. Performing TCD study at 10 minutes. Raising the tilt table to 70 degrees. Performing TCD study 5 minutes after tilting. Measuring blood pressure and symptoms for 10 minutes. Returning the tilt bed to supine position.

Study 2. in continue with study 1:

10 minutes lying on the tilt table. Performing TCD study at 10 minutes. Performing hand-grip at 50-70% grip force for 1 minute Raising the tilt table to 70 degrees. Performing TCD study 5 minutes after tilting. Measuring blood pressure and symptoms for 10 minutes. Returning the tilt bed to supine position.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Man or women
  • 18 years of age or older
  • Diagnosed with orthostatic hypotension due to Parkinson's disease, multiple system atrophy or pure autonomic failure
  • Orthostatic hypotension is not due to drugs, any heart disorder, anemia or dehydration

排除标准

  • Pregnant or breast feeding

结局指标

主要结局

Change in orthostatic blood fall after tilting with and without hand grip.

时间窗: 10 minutes after tilting the subjects.

Patients will be tilted to 70 degrees twice. Hand grip maneuver will be performed 1 minute before the second tilt study and the differences in blood pressure changes \[baseline-end tilt (mmHg)\] will be compared between the two studies and to those obtained from a healthy control group.

次要结局

  • Change in the intracranial blood flow after tilting with and without hand grip.(10 minutes after tilting.)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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