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Status unknownNCT01521221Updated Jan 30, 2012

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

A Phase 1 interventional study of Hand grip maneuver in Orthostatic Hypotension, sponsored by Tel-Aviv Sourasky Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-01-30.

Sponsored by Tel-Aviv Sourasky Medical Center · Phase 1, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2012), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Orthostatic Hypotension
03

In context

Hypotension, Orthostatic

155 studies on the registry are indexed under Hypotension, Orthostatic; 34 are open to participants now.

This study's planned enrollment of 20 is below the median of 30 across 113 interventional studies indexed under Hypotension, Orthostatic.

Browse Hypotension, Orthostatic studies →

Lead sponsor

Tel-Aviv Sourasky Medical Center is the lead sponsor of 541 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Pregnant or breast feeding
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Patients

    Patients with autonomic failure.

    Other: Hand grip maneuver

  • Experimental
    Healthy subjects

    Control group

    Other: Hand grip maneuver

Interventions

  • OtherHand grip maneuver

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 10 minutes after tilting the subjects.

Secondary outcomes

  1. 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.

    Time frame: 10 minutes after tilting.

07

Study locations

1 site
  • Movement disorders unit, the Department of Neurology, Sourasky Medical Center
    Tel Aviv, 64239, Israel
    • Amnon Mosek, MD · Contact · mosek@tasmc.health.gov.il · 972-3-6974874
    • Tania Gurevitch, MD · Contact · tanyag@tasmc.health.gov.il · 972-3-6974912
    • Amnon Mosek, MD · Principal investigator
    • Tanya Gurevitch, MD · Sub investigator
    • Hen Halevi, MD · Sub investigator
    • Marina Dano, MD · Sub investigator
    • Eli Atnasova, MD · Sub investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01521221
Lead sponsor
Tel-Aviv Sourasky Medical Center
Responsible party
Sponsor
First posted
Jan 30, 2012
Start date
Apr 2012
Primary completion
Apr 2013 (estimated)
Completion
Apr 2013 (estimated)
Last update
Jan 30, 2012

Study contacts

Amnon Mosek, MD
principal investigator · Deputy Chief, the Department of Neurology, Sourasky Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2012. You cannot join it, but the record below documents what was studied.

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