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

Orthostatic Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01521221
• Other study ID #: TASMC-08-AM-462-CTIL
• Status: Not yet recruiting
• Phase: Phase 1
• First received: August 15, 2011
• Last updated: January 25, 2012
• Start date: April 2012
• Est. completion date: April 2013

Study information

• Verified date: January 2012
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pregnant or breast feeding

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypotension
• Hypotension, Orthostatic
• Orthostatic Hypotension

Intervention

Other:
• Hand grip maneuver
Hand grip on blood pressue cuff slightly inflated at 50-70% of maximal force for 1 minute

Locations

Country	Name	City	State
Israel	Movement disorders unit, the Department of Neurology, Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in orthostatic blood fall after tilting with and without hand grip.	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.	10 minutes after tilting the subjects.	No
Secondary	Change in the intracranial blood flow after tilting with and without hand grip.	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.	10 minutes after tilting.	No