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

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.

Study Overview

• Status: Unknown
• Conditions: Orthostatic Hypotension
• Intervention / Treatment: Other: Hand grip maneuver

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel, 64239
    • Movement disorders unit, the Department of Neurology, Sourasky Medical Center
    • Contact: Tania Gurevitch, MD; Phone Number: 972-3-6974912; Email: tanyag@tasmc.health.gov.il
    • Sub-Investigator: Tanya Gurevitch, MD
    • Sub-Investigator: Hen Halevi, MD
    • Sub-Investigator: Eli Atnasova, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Patients; Patients with autonomic failure.	Other: Hand grip maneuver; Hand grip on blood pressue cuff slightly inflated at 50-70% of maximal force for 1 minute
EXPERIMENTAL: Healthy subjects; Control group	Other: Hand grip maneuver; Hand grip on blood pressue cuff slightly inflated at 50-70% of maximal force for 1 minute

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Amnon Mosek, MD, Deputy Chief, the Department of Neurology, Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (ANTICIPATED): April 1, 2013
• Study Completion (ANTICIPATED): April 1, 2013

Study Registration Dates

• First Submitted: August 15, 2011
• First Submitted That Met QC Criteria: January 25, 2012
• First Posted (ESTIMATE): January 30, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 30, 2012
• Last Update Submitted That Met QC Criteria: January 25, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Autonomic Nervous System Diseases; Primary Dysautonomias; Orthostatic Intolerance; Hypotension; Hypotension, Orthostatic
• Other Study ID Numbers: TASMC-08-AM-462-CTIL