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It was a pilot study and we enrolled sufficient numbers to evaluate the proposed outcomes.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device Guided Breathing/Combination Therapy | Active Comparator | 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. |
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| Isometric Hand Grip/Combination Therapy | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device guided breathing RESPeRATE | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth A Jackson, MD MPH FACC | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48106 | United States |
After consent, participants completed a run-in period in which they measured their blood pressure at home for 2 weeks. Participants with multiple readings greater than 160mmHg SBP or 100mmHg DBP were considered screen failures (n=13, plus 1 withdrawal).
Medical records were screened for initial eligibility criteria between 9/2014 - 4/2015. Patients were then contacted via letter and phone to gauge interest.
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| ID | Title | Description |
|---|---|---|
| FG000 | Device Guided Breathing | 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. Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, 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. Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing 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. |
| FG001 | Isometric Hand Grip | Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing. Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing 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. Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Single Modality |
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| Dual Modality |
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| ID | Title | Description |
|---|---|---|
| BG000 | Device Guided Breathing | 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. Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, 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. Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 9 subjects in each group were analyzed. These subjects represent the individuals who passed started the intervention phase of the study. | Posted | Mean | Standard Deviation | mmHg (millimeters of mercury) | 8 weeks and 16 weeks |
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We were in contact with subjects for 18 weeks total.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Device Guided Breathing | 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. Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, 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. Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| High blood pressure | Cardiac disorders | Non-systematic Assessment | Blood pressure readings of greater than 200mmHg systolic blood pressure and/or greater than 100mmHg diastolic pressure |
small sample size
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elizabeth Jackson | University of Michigan | 734-998-7411 | lisjacks@med.umich.edu |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Isometric hand grip Zona Plus | Device | 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. |
|
| 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. |
| 8 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| BG001 | Isometric Hand Grip | Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing. Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing 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. Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Systolic Blood pressure (mmHg) | Mean | Standard Deviation | mmHg |
|
| OG001 | Isometric Hand Grip | Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing. Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing 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. Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, 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. |
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| Secondary | 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. | Posted | Count of Participants | Participants | 8 weeks |
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| Secondary | 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. | Posted | Count of Participants | Participants | 8 weeks |
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| 0 |
| 9 |
| 0 |
| 9 |
| EG001 | Isometric Hand Grip | Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing. Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing 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. Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, 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. | 0 | 9 | 1 | 9 |
| EG002 | Screen Failures | These subjects reflect individuals who: 1) consented to be in the study, 2) participated in the initial run-in period to evaluate blood pressure, 3) ended up not meeting the blood pressure criteria required for randomization | 0 | 14 | 1 | 14 |
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| Tight blood pressure cuff | Investigations | Non-systematic Assessment | Blood pressure cuff was too tight for subject comfort |
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| Sore hands | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Musculoskeletal soreness from using the isometric handgrip device |
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