Evaluating the Safety and Effectiveness of Zona Plus Isometric Handgrip Therapy for Adults with Elevated Blood Pressure or Hypertension

What this Trial Is About

Researchers are conducting a multi-center, randomized clinical trial to assess the safety and effectiveness of the Zona Plus handgrip therapy device compared to auditory relaxation therapy in adults with elevated blood pressure or hypertension who are not currently taking blood pressure medications. This study aims to better understand how these therapies may help manage blood pressure. Participants will be adults aged 22 and older with systolic blood pressure between 130 and 149 mmHg, with additional monitoring for those between 140 and 149 mmHg. Participants assigned to the Zona Plus Device group will perform isometric handgrip exercises using the device, which tracks compliance electronically. Those in the control group will listen to relaxing music through a mobile app and record their adherence in a diary. Some control participants may switch to the Zona Plus device after completing their sixth study visit. The study also includes a subgroup randomized to record their blood pressure at home. The treatment period lasts about 10 weeks, with additional monitoring visits for certain participants. Throughout the 3 to 8 months of participation, subjects will attend scheduled study visits for blood pressure measurements and device training. Researchers will evaluate changes in systolic and diastolic blood pressure after 10 weeks and monitor compliance with assigned therapies. The study will also track safety and any significant reductions in blood pressure. Participants are expected to maintain their usual health routines without starting new blood pressure medications during the study.

A Pivotal Study to Evaluate the Effectiveness of Isometric Handgrip Therapy in Elevated Blood Pressure and Hypertensive Subjects