Actively Recruiting
A Pivotal Study to Evaluate the Effectiveness of Isometric Handgrip Therapy in Elevated Blood Pressure and Hypertensive Subjects
Led by Zona Health, Inc · Updated on 2025-07-10
160
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
Z
Zona Health, Inc
Lead Sponsor
E
Emergent Clinical Consulting, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the Zona Plus handgrip therapy device compared to listening to relaxing music for treating elevated blood pressure and hypertension in adults not currently on blood pressure medications. This randomized clinical trial includes participants with systolic blood pressure between 130 and 149 mmHg and aims to understand how these therapies impact blood pressure over time. Participants are assigned to either use the Zona Plus device, which involves performing isometric handgrip exercises monitored through the device's electronic memory, or to listen to relaxing music via a mobile app, recording their compliance in a diary. Those in the control group may switch to the Zona Plus device after their sixth study visit. Participants with systolic blood pressure between 140 and 149 mmHg at the start will have three additional monitoring visits. The study duration ranges from 3 to 8 months. During the study, participants will attend multiple clinic visits for blood pressure measurement and device training. Researchers will assess changes in systolic and diastolic blood pressure after 10 weeks of treatment, as well as the percentage of participants achieving significant blood pressure reductions. Compliance is tracked through device memory or patient diaries. Safety and effectiveness are monitored throughout the study, which is expected to end in May 2027.
CONDITIONS
Brief Title
A Pivotal Study to Evaluate the Effectiveness of Isometric Handgrip Therapy in Elevated Blood Pressure and Hypertensive Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 22 years or older
- Diagnosed with elevated blood pressure or hypertension confirmed by standardized seated cuff systolic blood pressure
- No antihypertensive medication use for at least 30 days before screening
- Sufficient vision, hearing, and hand strength (measured as 35 units of force in both hands)
- Completed baseline blood pressure measurements and device training during initial visit
- Agrees to avoid blood pressure medications and related supplements during treatment phase
- Able and willing to complete all study procedures and visits
- Able to understand and provide written informed consent
- Baseline systolic blood pressure between 130 and 149 mmHg, with extra monitoring if 140 mmHg or above
You will not qualify if you...
- Female of childbearing potential not using effective birth control or pregnant, lactating, or planning pregnancy during the study
- Systolic blood pressure 150 mmHg or higher and/or diastolic blood pressure over 90 mmHg
- History of severe heart failure (NYHA class III-IV)
- Current or past history of atrial fibrillation
- Hospitalization for hypertensive emergency with organ damage within past 6 months
- Greater than 10 mmHg difference in systolic blood pressure between arms
- Unstable blood pressure with high variability during baseline readings
- Arm circumference greater than 45 cm
- Acute illness, infection, or inflammation
- Unstable cardiovascular disorders or serious comorbidities affecting life expectancy or study compliance
- History of angina in the past 6 months
- History of solid organ transplant
- Secondary causes of hypertension like primary aldosteronism or thyroid disease
- Participation in other investigational studies within the past 6 months
- Conditions or circumstances that may interfere with study compliance or data quality
- Current or prior use of Zona Plus device and performance of handgrip exercises
- Plans for more than 10% body weight change during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 weeks
Participants use either the Zona Plus device for isometric handgrip therapy or listen to relaxing music via a mobile app, with compliance monitored accordingly.
Multiple visits including baseline and follow-up visits over 10 weeks
Duration - Up to 8 months total participation
Participants with baseline systolic blood pressure between 140 mmHg and 149 mmHg complete additional visits for further monitoring.
3 additional visits depending on blood pressure levels
Trial Site Locations
Total: 5 locations
1
Bayview Research Group
Valley Village, California, United States, 91607
Actively Recruiting
2
AMR Miami
Coral Gables, Florida, United States, 33134
Actively Recruiting
3
Cedar Crosse Research Center
Chicago, Illinois, United States, 60607
Actively Recruiting
4
Circuit Clinical Grave Gilbert
Bowling Green, Kentucky, United States, 42101
Actively Recruiting
5
AMR Knoxville
Knoxville, Tennessee, United States, 37909
Actively Recruiting
Research Team
M
Martyna Stankute
M
Mark Young
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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