Hypertension
Conditions
Keywords
High blood pressure
Brief summary
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.
Interventions
DEVICEDevice guided breathing RESPeRATE
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.
DEVICEIsometric hand grip Zona Plus
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.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Are at least 21 years old, and * Have Stage 1 high blood pressure. (Defined as a systolic blood pressure between 140 mm Hg and 159 mm Hg (the top blood pressure number) and/or a diastolic blood pressure between 90 mm Hg and 99 mm Hg (the bottom blood pressure number) in the prior 6 months.)
Exclusion criteria
* Take drugs to control blood pressure. * Have a history of left ventricular hypertrophy. * Have a history of cardiovascular disease such as stroke, mini-strokes, heart attack, unstable angina, bypass surgery, stents, angioplasty, abnormal heart rhythms, heart failure, or peripheral artery disease. * Have diabetes. * Have a history of poor kidney function. * Have an upper arm circumference greater than 17 inches. * Are currently participating in a formal exercise or weight loss program. * Plan to participate in a formal exercise or weight loss program in the next 6 months. * Are pregnant or plan to become pregnant in the next 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Blood Pressure | 8 weeks and 16 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to Single Modality Exercise (Device Guided Breathing or Isometric Hand Grip) | 8 weeks | 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. |
| Adherence to Dual Modality Exercise (Device Guided Breathing + Isometric Hand Grip) | 8 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
Medical records were screened for initial eligibility criteria between 9/2014 - 4/2015. Patients were then contacted via letter and phone to gauge interest.
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 9 |
| 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. | 9 |
| Total | 18 |
Baseline characteristics
| Characteristic | Device Guided Breathing | Total | Isometric Hand Grip |
|---|---|---|---|
| Age, Continuous | 56.75 years STANDARD_DEVIATION 14.85 | 54.59 years STANDARD_DEVIATION 14.85 | 52.67 years STANDARD_DEVIATION 15.48 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 14 Participants | 7 Participants |
| Sex: Female, Male Female | 2 Participants | 7 Participants | 5 Participants |
| Sex: Female, Male Male | 7 Participants | 11 Participants | 4 Participants |
| Systolic Blood pressure (mmHg) | 127.33 mmHg STANDARD_DEVIATION 10.15 | 129.06 mmHg STANDARD_DEVIATION 9 | 133.57 mmHg STANDARD_DEVIATION 17.89 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 1 / 9 | 1 / 14 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 | 0 / 14 |
Outcome results
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.
Time frame: 8 weeks and 16 weeks
Population: 9 subjects in each group were analyzed. These subjects represent the individuals who passed started the intervention phase of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Device Guided Breathing | Change in Blood Pressure | Baseline Systolic Blood Pressure | 127.33 mmHg (millimeters of mercury) | Standard Deviation 10.15 |
| Device Guided Breathing | Change in Blood Pressure | Change from baseline at 8-weeks | 5.71 mmHg (millimeters of mercury) | Standard Deviation 13.92 |
| Device Guided Breathing | Change in Blood Pressure | Change from baseline at 16-weeks | 3.50 mmHg (millimeters of mercury) | Standard Deviation 10.344 |
| Isometric Hand Grip | Change in Blood Pressure | Baseline Systolic Blood Pressure | 133.57 mmHg (millimeters of mercury) | Standard Deviation 17.89 |
| Isometric Hand Grip | Change in Blood Pressure | Change from baseline at 8-weeks | 3.43 mmHg (millimeters of mercury) | Standard Deviation 8 |
| Isometric Hand Grip | Change in Blood Pressure | Change from baseline at 16-weeks | 6.17 mmHg (millimeters of mercury) | Standard Deviation 12.3 |
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.
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Guided Breathing | Adherence to Dual Modality Exercise (Device Guided Breathing + Isometric Hand Grip) | 3 Participants |
| Isometric Hand Grip | Adherence to Dual Modality Exercise (Device Guided Breathing + Isometric Hand Grip) | 3 Participants |
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.
Time frame: 8 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Device Guided Breathing | Adherence to Single Modality Exercise (Device Guided Breathing or Isometric Hand Grip) | 7 Participants |
| Isometric Hand Grip | Adherence to Single Modality Exercise (Device Guided Breathing or Isometric Hand Grip) | 4 Participants |