An interventional study of Device guided breathing RESPeRATE and Isometric hand grip Zona Plus in Hypertension, sponsored by University of Michigan. Terminated at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2017-03-28.
Sponsored by University of Michigan · Not applicable, Interventional, and Treatment
An estimated 76 million adults in the United States over the age of 20 have hypertension (HTN); which translates into 1 out of 3 adults. Globally the prevalence of HTN is over 25% for adults, and accounts for approximately 13.5% of all deaths. Given the aging of the population together with increases in obesity and sedentary behavior, it is not surprising that HTN is projected to increase significantly over the next several decades; with over 1.5 billion adults having HTN by the year 2025. Thus the public health implications to preventing and/or reducing elevations in blood pressure are substantial.
This study compares the efficacy of two different non-pharmacologic interventions (device guided breathing and isometric hand grip exercises) used alone and in combination for lowering blood pressure. This pilot study will include 30 adults with stage 1 hypertension. The primary outcome is the change in blood pressure from baseline to 8 weeks. Secondary outcomes include change in blood pressure from 8 weeks to 16 weeks and acceptability of the interventions by participants. The knowledge gained from this study can provide information on non-pharmacologic methods that may be useful in decreasing blood pressure. Such knowledge may be especially useful for patients for whom access to medications and health care is limited and among patients unwilling to take or intolerant to pharmacologic therapies.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 32 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.
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Exclusion Criteria:
Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises. Participants will be given a home blood pressure monitor. Participants will measure blood pressure and heart rate at home for 2 weeks prior to starting any intervention and also during the 16 week of intervention.
Device: Device guided breathing RESPeRATE · Device: Isometric hand grip Zona Plus
Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises. Participants will be given a home blood pressure monitor. Participants will measure blood pressure and heart rate at home for 2 weeks prior to starting any intervention and also during the 16 week of intervention.
Device: Device guided breathing RESPeRATE · Device: Isometric hand grip Zona Plus
Participants will use a device called RESPeRATE which will measure how many breaths they take per minute. A strap wraps around the participants chest that measures breathing frequency. Headphones plug into the device to inform participants about their breathing. The device will help guide participants to breathe slowly using musical tones, with a goal of about ten breaths per minute. Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.
Participants will use a device called the Zona Plus, which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing the device followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise. Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.
Change in Blood Pressure
Blood pressure was measured using an automated cuff with subject in a seated position for at least 5 minutes. Six measurements were recorded at 1-minute intervals. The mean was used in analysis.
Time frame: 8 weeks and 16 weeks
Adherence to Single Modality Exercise (Device Guided Breathing or Isometric Hand Grip)
Subjects recorded sessions on a log; they were expected to complete 5 days/week for 8 weeks of single modality exercise for a minimum of 40 reported sessions. Results are reported as number of subjects reporting a minimum of 40 sessions.
Time frame: 8 weeks
Adherence to Dual Modality Exercise (Device Guided Breathing + Isometric Hand Grip)
Subjects recorded sessions on a log; they were expected to complete 5 days/week for 8 weeks of single modality exercise for a minimum of 40 reported sessions. Results are reported as number of subjects reporting a minimum of 40 sessions.
Time frame: 8 weeks
Medical records were screened for initial eligibility criteria between 9/2014 - 4/2015. Patients were then contacted via letter and phone to gauge interest.
| Milestone | Device Guided Breathing | Isometric Hand Grip |
|---|---|---|
| Started | 9 | 9 |
| Completed | 7 | 8 |
| Not completed | 2 | 1 |
| Milestone | Device Guided Breathing | Isometric Hand Grip |
|---|---|---|
| Started | 7 | 8 |
| Began active treatment | 7 | 7 |
| Completed | 5 | 7 |
| Not completed | 2 | 1 |
Blood pressure was measured using an automated cuff with subject in a seated position for at least 5 minutes. Six measurements were recorded at 1-minute intervals. The mean was used in analysis.
| mmHg (millimeters of mercury) | Device Guided Breathing | Isometric Hand Grip |
|---|---|---|
| Baseline Systolic Blood Pressure | 127.33 ± 10.15 | 133.57 ± 17.89 |
| Change from baseline at 8-weeks | 5.71 ± 13.92 | 3.43 ± 8.00 |
| Change from baseline at 16-weeks | 3.50 ± 10.344 | 6.17 ± 12.30 |
Subjects recorded sessions on a log; they were expected to complete 5 days/week for 8 weeks of single modality exercise for a minimum of 40 reported sessions. Results are reported as number of subjects reporting a minimum of 40 sessions.
| Participants | Device Guided Breathing | Isometric Hand Grip |
|---|---|---|
| Adherence to Single Modality Exercise (Device Guided Breathing or Isometric Hand Grip) | 7 | 4 |
Subjects recorded sessions on a log; they were expected to complete 5 days/week for 8 weeks of single modality exercise for a minimum of 40 reported sessions. Results are reported as number of subjects reporting a minimum of 40 sessions.
| Participants | Device Guided Breathing | Isometric Hand Grip |
|---|---|---|
| Adherence to Dual Modality Exercise (Device Guided Breathing + Isometric Hand Grip) | 3 | 3 |
Collected over We were in contact with subjects for 18 weeks total.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Device Guided Breathing | — | 0/9 (0%) | 0/9 (0%) |
| Isometric Hand Grip | — | 0/9 (0%) | 1/9 (11.1%) |
| Screen Failures | — | 0/14 (0%) | 1/14 (7.1%) |
| Event | Device Guided Breathing | Isometric Hand Grip | Screen Failures |
|---|---|---|---|
| Sore handsMusculoskeletal and connective tissue disorders | 0/9 | 1/9 | 0/14 |
| High blood pressureCardiac disorders | 0/9 | 0/9 | 1/14 |
| Tight blood pressure cuffInvestigations | 0/9 | 0/9 | 1/14 |
| Age, Continuous(years) | Device Guided Breathing | Isometric Hand Grip | Total |
|---|---|---|---|
| Mean | 56.75 ± 14.85 | 52.67 ± 15.48 | 54.59 ± 14.85 |
| Sex: Female, Male(Participants) | Device Guided Breathing | Isometric Hand Grip | Total |
|---|---|---|---|
| Female | 2 | 5 | 7 |
| Male | 7 | 4 | 11 |
| Race (NIH/OMB)(Participants) | Device Guided Breathing | Isometric Hand Grip | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 7 | 7 | 14 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Systolic Blood pressure (mmHg)(mmHg) | Device Guided Breathing | Isometric Hand Grip | Total |
|---|---|---|---|
| Mean | 127.33 ± 10.15 | 133.57 ± 17.89 | 129.06 ± 9.00 |
This study is terminated, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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