Handgrip Therapy for High Blood Pressure

Recruiting at 8 trial locations

Overseen By Mark Young

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Zona Health, Inc

Must not be taking: Antihypertensives

Disqualifiers: Pregnancy, Heart failure, Atrial fibrillation, Hypertensive emergency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 3-8 months

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods to manage high blood pressure: a handgrip device called Zona Plus and listening to relaxing music. Researchers aim to determine if using the device can safely lower blood pressure in individuals not taking blood pressure medication. Those with high blood pressure, who are not on medication and whose blood pressure is not excessively high, might be suitable for this study. Participants will monitor their blood pressure at home during the trial. As an unphased trial, this study provides a unique opportunity to investigate innovative, non-medication approaches to managing blood pressure.

Will I have to stop taking my current medications?

The trial requires that participants do not take any medications or over-the-counter supplements related to high blood pressure during the study.

What prior data suggests that the Zona Plus device is safe for treating high blood pressure?

Research has shown that the Zona Plus device has no known side effects in clinical studies. This handgrip tool aims to lower high blood pressure without medication. Several studies have examined its safety and found it well-tolerated, with users reporting no major negative effects. While prioritizing safety remains crucial, current evidence suggests that the Zona Plus is safe for managing high blood pressure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for high blood pressure, which often include medications like ACE inhibitors, beta-blockers, or diuretics, the Zona Plus Device offers a unique non-pharmacological approach. It uses isometric handgrip therapy, a method that involves squeezing the device at specific intervals to help lower blood pressure. Researchers are excited because this method could offer a drug-free alternative with fewer side effects, and it empowers patients to take an active role in managing their condition through simple exercises.

What evidence suggests that the Zona Plus device is effective for high blood pressure?

Research has shown that the Zona Plus handgrip therapy device, which participants in this trial may use, can help lower blood pressure. Studies have found that using the Zona Plus significantly reduces both the systolic and diastolic numbers of a blood pressure reading, as well as the overall average pressure. This suggests that the device can help manage high blood pressure without medication. The Zona Plus uses isometric exercise, which strengthens the heart and lowers blood pressure. This drug-free method might be a good option for those seeking alternative ways to control high blood pressure. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for adults aged 22 or older with high blood pressure (130 to ≤149 mmHg systolic) who haven't taken antihypertensive meds for at least 30 days. Participants must not be on hypertension-related OTC supplements, have good vision, hearing, and hand strength. Pregnant women, those with severe heart issues or recent cardiovascular events, and individuals with unstable blood pressure are excluded.

Inclusion Criteria

I have been diagnosed with high blood pressure.

Subject has baseline BP measurements collected and completes study device training during Baseline Assessment (Visit #1)

Patient must be able to understand and give written informed consent in the language provided

Exclusion Criteria

BP ≥150 mmHg (systolic) and/or >90 mmHg (diastolic)

I am a woman who could become pregnant and am not using or plan to use effective birth control during the study.

I have severe heart failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either the Zona Plus Device arm for isometric therapy or the control arm for auditory relaxation therapy

3-8 months

6 visits (in-person)

Crossover

Control arm participants may crossover to using the Zona Plus device after Study Visit 6

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Zona Plus Device

Trial Overview The study tests the Zona Plus handgrip therapy device against an auditory relaxation app in managing high blood pressure without medication. Half of the participants will also monitor their blood pressure at home. It's a randomized trial across multiple centers to assess safety and effectiveness.

How Is the Trial Designed?

Group I: Investigational Experimental Treatment 1 Intervention

Zona Plus Device

Group II: Control Active Control 1 Intervention

Relaxing music

Who Is Running the Clinical Trial?

Zona Health, Inc

Lead Sponsor

Trials

2

Recruited

310+

Emergent Clinical Consulting, LLC

Industry Sponsor

Trials

6

Recruited

2,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6600323/

Blood pressure lowering effects of a novel isometric exercise ... The results of this study indicate that both the ZON and IB devices elicit significant SBP, DBP and MAP reductions.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06843577

NCT06843577 | A Pivotal Study to Evaluate the ... The study will be a multi-center, randomized clinical trial to evaluate the safety and efficacy of using the Zona Plus handgrip therapy device compared to ...

3. fda.gov fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zona-health-inc-584676-12062019

Zona Health Inc. - 584676 - 12/06/2019 "You can still get the same blood pressure-lowering results with the Zona Plus without transferring your data to a computer." Because there ...

4. ecrjournal.com ecrjournal.com/articles/non-pharmacological-interventions-patients-resistant-hypertension?language_content_entity=en

Non-pharmacological Interventions for Patients with ... We give an overview of three novel, non-pharmacological therapies available for patients with resistant hypertension, including an implantable carotid ...

5. withpower.com withpower.com/trial/handgrip-therapy-for-high-blood-pressure-7e9f6

Handgrip Therapy for High Blood Pressure The study will be a multi-center, randomized clinical trial to evaluate the safety and efficacy of using the Zona Plus handgrip therapy device compared to ...

6. zona.com zona.com/pages/faqs?srsltid=AfmBOoo-FnoPqzfIz1FjiwE7uR383r_UPBYh1nW-vjYNxhORm83XnYeO

FAQs Although the Zona Plus has no known side effects, safety should always be your first consideration. ... You can still get the same results with the Zona Plus ...