Clinical Trial: Assessment of Hand-grip in the Prevention of Postural Orthostatic Hypotension

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Assessment of Hand-grip in the Prevention of Postural Orthostatic Hypotension

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Tel-Aviv Sourasky Medical Center

Current Primary Outcome: Change in orthostatic blood fall after tilting with and without hand grip. [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Change in the intracranial blood flow after tilting with and without hand grip. [ Time Frame: 10 minutes after tilting. ]

Intracranial blood flow will be evaluated by transcranial doppler at baseline and after tilting. Differences will be compared [peak systolic flow (PSW) cm/sec], after tilting with and without prior hand grip and in comparison to tilting a control group.


Original Secondary Outcome: Same as current

Information By: Tel-Aviv Sourasky Medical Center

Dates:
Date Received: August 15, 2011
Date Started: April 2012
Date Completion: April 2013
Last Updated: January 25, 2012
Last Verified: January 2012