Isometric handgrip therapy with the Zona Plus device for high blood pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-center, randomized trial comparing a home-use Zona Plus isometric handgrip device to an auditory relaxation (music) app in adults with elevated blood pressure or hypertension who are not on antihypertensive medications. Participants randomized to the Zona Plus arm perform prescribed isometric handgrip sessions with device-recorded compliance; control participants listen to relaxing music and record compliance in a diary. Half of participants are further randomized to record blood pressure at home during the study, and those with baseline systolic BP 140–149 mmHg have three additional monitoring visits. Total participation lasts about 3–8 months and control-arm participants may cross over to the device after Visit 6.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Subject is male or female age 22 or older
2. Diagnosed with elevated blood pressure or hypertension and verified during Visit #1 by standardized seated cuff SBP
3. Have not taken antihypertensive medication for ≥30 days prior to the SEPV
4. Subject is expected to have sufficient vision, hearing, and hand strength (hand strength is demonstrated by a maximum voluntary contraction (MVC) equaling 35 units of force in both hands measured by a dynamometer
5. Subject has baseline BP measurements collected and completes study device training during Baseline Assessment (Visit #1);
6. Subject agrees to maintain non-use of medications and over-the-counter (OTC) supplement regimen related to hypertension throughout the treatment phase;
7. Patient can comply with and agrees to complete all required study procedures, study clinic visits, and associated activities;
8. Patient must be able to understand and give written informed consent in the language provided;
9. Subject must have SBP of 130 to ≤149 mmHg, if subjects present with SBP reading of ≥140mmHg they will receive heightened monitoring throughout the first month of the study

Exclusion Criteria:

1. Subject is a female of childbearing potential (e.g., not postmenopausal for at least one year or has not had a hysterectomy or tubal ligation) not using medically effective birth control (e.g., hormonal methods in use at least 30 days prior to screening or barrier methods such as condom and spermicide in use at least 14 days prior to visit 1) or is pregnant, lactating, or plans to become pregnant during the study).
2. BP ≥150 mmHg (systolic) and/or \>90 mmHg (diastolic)
3. A history of heart failure with current New York Heart Association (NYHA) class III- IV functional classification
4. Currently has, or has had a history, of atrial fibrillation, in accordance with 2007 Heart Rhythm Society (HRS)/European Heart Rhythm Association (EHRA)/European Cardiac Arrhythmia Society (ECAS) guidelines
5. Patient has experienced hospitalization due to a hypertensive emergency, with impending or progressive target organ dysfunction (i.e., renal dysfunction, left ventricular hypertrophy or CNS involvement) within the past six (6) months
6. A \>10 mmHg difference in seated cuff SBP between the right and left arms collected during the SEPV;
7. Unstable BP, defined as \>5 mmHg variance between any two (2) consecutive weekly readings (with a maximum of four (4) attempts) to determine a baseline BP measurement ;
8. Arm circumference greater than 45 cm;
9. Acute illness, infection, or inflammation
10. Presence of any unstable cardiovascular disorder, such as MI, unstable angina, significant arrhythmia, stroke, or TIA; within the last six (6) months, or other serious comorbidity that would be likely to impact life expectancy to less than one (1) year or limit patient cooperation or study compliance;
11. A history of rest or exertional angina pectoris in the previous six (6) months;
12. History of solid organ transplant
13. Any secondary form of hypertension (HTN) etiology, including but not limited to primary aldosteronism, chronic steroid therapy and Cushing syndrome, pheochromocytoma, aorta coarctation or untreated thyroid or parathyroid disease;
14. Concurrent participation in an investigational clinical study that has not completed the follow-up period or planned participation in another study within the next six (6) months;
15. Patient has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete, good quality data or the completion of the research study;
16. Patients who currently own or have owned another Zona Plus device and are, or have been, voluntarily performing the isometric handgrip activities.
17. Subject plans for greater than 10% of body weight loss/gain (10% of body weight over a 6-month period) during the study

Where it's running

• Bayview Research Group
  Valley Village, California, United States Recruiting
• Focus Clinical Research
  West Hills, California, United States Recruiting
• Comprehensive Medical & Research
  Plantation, Florida, United States Recruiting
• Cedar Crosse Research Center
  Chicago, Illinois, United States Recruiting
• Circuit Clinical Grave Gilbert
  Bowling Green, Kentucky, United States Recruiting
• Preferred Primary Care Physicians - Pittsburgh
  Pittsburgh, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Brandi Caughman
• Email: brandi@emergentcro.com
• Phone: 610-454-7200

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Isometric Handgrip Exercise for Older Adults with High Blood Pressure: A Feasibility Pilot

  This study tests whether a short, supervised handgrip program can be done safely in community settings by older adults with hypertension to see if it helps lower blood pressure and may boost cognitive function.

  Recruiting at 2 sites McMaster University · Hamilton, Ontario and 1 other locations · NCT07648498

• HJB647 in Japanese adults with elevated blood pressure and hypertension

  This study tests safety, tolerability, and how the body handles HJB647 after single and multiple doses in Japanese adults with elevated blood pressure and in patients with hypertension.

  Recruiting Phase 1 Novartis · Sumida Ku, Tokyo · NCT07644364

• Exercise type and timing for blood pressure and eye pressure in glaucoma

  This study tests whether different kinds and times of exercise can safely lower blood pressure and eye pressure in adults with primary open-angle glaucoma and high blood pressure.

  Recruiting KU Leuven · Leuven · NCT07413614

• Effects of isometric exercise on blood pressure in inactive adults

  This study is testing whether doing isometric exercises can help lower blood pressure in adults who don't usually exercise.

  Recruiting Canterbury Christ Church University · Canterbury, Kent · NCT06937164

• Home-delivered DASH groceries for Southeastern US residents to lower blood pressure

  This project will test whether adults with high blood pressure in Florida, Georgia, and Tennessee who receive dietitian‑assisted, home‑delivered DASH groceries for 4 weeks have larger blood pressure drops than those given a shopping stipend and a DASH brochure.

  Recruiting Beth Israel Deaconess Medical Center · Boston, Massachusetts · NCT06891911

• Digital health coaching using wearable technology for chronic disease prevention

  This study is testing whether digital health coaching with wearable technology can help people at risk of chronic diseases like high blood pressure and diabetes make healthier lifestyle choices to prevent these conditions.

  Recruiting Alexandra Hospital · Singapore · NCT06752772

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.