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

NCT ID: NCT01521221

Last Updated: 2012-01-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-04-30

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 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.

Conditions

Orthostatic Hypotension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Patients

Patients with autonomic failure.

Group Type: EXPERIMENTAL

Hand grip maneuver

Intervention Type: OTHER

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

Healthy subjects

Control group

Group Type: EXPERIMENTAL

Hand grip maneuver

Intervention Type: OTHER

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

Interventions

Hand grip maneuver

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amnon Mosek, MD

Role: PRINCIPAL_INVESTIGATOR

Deputy Chief, the Department of Neurology, Sourasky Medical Center

Locations

Movement disorders unit, the Department of Neurology, Sourasky Medical Center

Tel Aviv, , Israel

Countries

Israel

Facility Contacts

Amnon Mosek, MD

Role: primary

mosek@tasmc.health.gov.il

972-3-6974874

Tania Gurevitch, MD

Role: backup

tanyag@tasmc.health.gov.il

972-3-6974912

Other Identifiers

TASMC-08-AM-462-CTIL

Identifier Type: -

Identifier Source: org_study_id