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Behavioural Intervention

Zona Plus Device for High Blood Pressure

N/A
Waitlist Available
Research Sponsored by Zona Health, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to day 160 ± 4 days
Awards & highlights

Study Summary

This study is evaluating whether a specific type of exercise may help reduce blood pressure.

Eligible Conditions
  • High Blood Pressure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to day 160 ± 4 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to day 160 ± 4 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Systolic Blood Pressure to Day 70 ± 2 Days
Secondary outcome measures
Change from Baseline in Diastolic Blood Pressure to Day 70 ± 2 Days
Comparison of Heart Rate between Zona Plus nominal device and Placebo controlled device
Percentage change from Baseline in Diastolic Blood Pressure reduction at Day 70 ± 2 Days
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Zona Plus - Active - "Normal Grip"Experimental Treatment1 Intervention
Using the Zona Plus Device, the patient will perform a twelve-minute isometric handgrip therapy session at approximately the same time each day . After an initial handgrip strength assessment (the session calibration), a two-minute isometric routine is performed four times, two sessions per hand, with a one-minute non-grip, or rest session between each isometric routine.
Group II: Control Device - Sham - "Weaker Grip"Placebo Group1 Intervention
Using the Zona Sham Control Device the patient will perform a twelve-minute isometric handgrip therapy session at approximately the same time each day. After an initial handgrip strength assessment (the calibration), a two-minute isometric routine is performed four times, two sessions per hand, with a one-minute non-grip, or rest session between each isometric routine.

Find a Location

Who is running the clinical trial?

Zona Health, IncLead Sponsor
Research & Development Concierge CompanyUNKNOWN
Glenn Loomis, MDStudy DirectorResearch & Development Concierge

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
CirculationJournal
Recommendations for Blood Pressure Measurement in Humans and Experimental Animals
Pickering, Thomas G., John E. Hall, Lawrence J. Appel, Bonita E. Falkner, John Graves, Martha N. Hill, Daniel W. Jones, Theodore Kurtz, Sheldon G. Sheps, and Edward J. Roccella. 2005. “Recommendations for Blood Pressure Measurement in Humans and Experimental Animals”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/01.cir.0000154900.76284.f6.
JAMA: The Journal of the American Medical AssociationJournal
Major Outcomes in High-risk Hypertensive Patients Randomized to Angiotensin-converting Enzyme Inhibitor or Calcium Channel Blocker Vs Diuretic: The Antihypertensive and Lipid-lowering Treatment to Prevent Heart Attack Trial (ALLHAT)
The ALLHAT Officers and Coordinators for the ALLHAT Collaborative Research Group. 2002. “Major Outcomes in High-risk Hypertensive Patients Randomized to Angiotensin-converting Enzyme Inhibitor or Calcium Channel Blocker Vs Diuretic: The Antihypertensive and Lipid-lowering Treatment to Prevent Heart Attack Trial (ALLHAT)”. JAMA: The Journal of the American Medical Association. American Medical Association (AMA). doi:10.1001/jama.288.23.2981.
New England Journal of MedicineJournal
Effects on Blood Pressure of Reduced Dietary Sodium and the Dietary Approaches to Stop Hypertension (DASH) Diet
Sacks, Frank M., Laura P. Svetkey, William M. Vollmer, Lawrence J. Appel, George A. Bray, David Harsha, Eva Obarzanek, et al.. 2001. “Effects on Blood Pressure of Reduced Dietary Sodium and the Dietary Approaches to Stop Hypertension (DASH) Diet”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejm200101043440101.
CirculationJournal
Heart Disease and Stroke Statistics—2011 Update
Roger, Véronique L., Alan S. Go, Donald M. Lloyd-Jones, Robert J. Adams, Jarett D. Berry, Todd M. Brown, Mercedes R. Carnethon, et al.. 2011. “Heart Disease and Stroke Statistics—2011 Update”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/cir.0b013e3182009701.
~30 spots leftby Apr 2025
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