A Pivotal Study to Evaluate the Effectiveness of Isometric Handgrip Therapy in Elevated Blood Pressure and Hypertensive Subjects
Zona Health, Inc
Summary
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 the use of an auditory relaxation therapy for treatment of high blood pressure and hypertension in subjects who are not currently taking antihypertensive medications. Half of the study subjects will also be randomized to record blood pressure at home throughout the study.
Description
Study subjects randomized to the Zona Plus Device arm will perform isometric therapy with the device with subject compliance monitored through a downloadable electronic memory function built into the device. Study subjects randomized to the control arm will be asked to listen to relaxing music via a mobile app and asked to document their compliance via a patient diary. Subjects in the control arm may be able to crossover to using the Zona Plus device after completion of Study Visit 6. Subjects who have systolic blood pressure between 140mmHG and 149mmHG at baseline will complete three addition…
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceZona Plus Device
Use of the Zona Plus device involves performing isometric handgrip exercise therapy. Isometric exercise is the type of exercise in which you tense or tighten your muscle without seeing it change in length.
- OtherRelaxing Music App
Relaxing music will be made available through a mobile app that users access via their smart phone or tablet. Subjects will have the option to listen to 5 different music genres that support relaxation (Classical, Nature, Movie Soundtracks, Jazz, Reggae).
Locations (5)
- Bayview Research GroupValley Village, California
- AMR MiamiCoral Gables, Florida
- Cedar Crosse Research CenterChicago, Illinois
- Circuit Clinical Grave GilbertBowling Green, Kentucky
- AMR KnoxvilleKnoxville, Tennessee