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

Tel Aviv Sourasky Medical Center

Status and phase: Unknown; Phase 1

Conditions: Orthostatic Hypotension

Treatments: Other: Hand grip maneuver

Study type: Interventional

Funder types: Other

Identifiers

NCT01521221

TASMC-08-AM-462-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Patients

Experimental group

Description:

Patients with autonomic failure.

Treatment:

Other: Hand grip maneuver

Healthy subjects

Experimental group

Description:

Control group

Treatment:

Other: Hand grip maneuver