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

Primary Purpose

Orthostatic Hypotension

Status

Unknown status

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

Hand grip maneuver

About this trial

This is an interventional prevention trial for Orthostatic Hypotension

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Patients

Healthy subjects

Arm Description

Patients with autonomic failure.

Control group

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01521221

First Posted

August 15, 2011

Last Updated

January 25, 2012

Sponsor

Tel-Aviv Sourasky Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01521221

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Unknown status

Study Start Date

April 2012 (undefined)

Primary Completion Date

April 2013 (Anticipated)

Study Completion Date

April 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tel-Aviv Sourasky Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Orthostatic Hypotension

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients

Arm Type

Experimental

Arm Description

Patients with autonomic failure.

Arm Title

Healthy subjects

Arm Type

Experimental

Arm Description

Control group

Intervention Type

Other

Intervention Name(s)

Hand grip maneuver

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in orthostatic blood fall after tilting with and without hand grip.

Description

Time Frame

10 minutes after tilting the subjects.

Secondary Outcome Measure Information:

Title

Change in the intracranial blood flow after tilting with and without hand grip.

Description

Time Frame

10 minutes after tilting.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Amnon Mosek, MD

Organizational Affiliation

Deputy Chief, the Department of Neurology, Sourasky Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Tel Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amnon Mosek, MD

Phone

972-3-6974874

mosek@tasmc.health.gov.il

First Name & Middle Initial & Last Name & Degree

Tania Gurevitch, MD

Phone

972-3-6974912

tanyag@tasmc.health.gov.il

First Name & Middle Initial & Last Name & Degree

Amnon Mosek, MD

First Name & Middle Initial & Last Name & Degree

Tanya Gurevitch, MD

First Name & Middle Initial & Last Name & Degree

Hen Halevi, MD

First Name & Middle Initial & Last Name & Degree

Marina Dano, MD

First Name & Middle Initial & Last Name & Degree

Eli Atnasova, MD

12. IPD Sharing Statement

Learn more about this trial

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

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