Elevated Blood Pressure
Conditions
Brief summary
This study evaluates the impact of mindfulness-based stress reduction (MBSR) on sympathetic nerve activity and arterial stiffness. The investigator's central hypothesis is that MBSR will reduce sympathetic activity and arterial stiffness.
Detailed description
This study will recruit male and female subjects with elevated blood pressure who will participate in a randomized, active control study to examine the impact of mindfulness-based stress reduction (MBSR) on blood pressure, muscle sympathetic nerve activity and arterial stiffness. The study will utilize established techniques for assessing blood pressure patterns (24-hour ambulatory monitoring), peripheral sympathetic activity (microneurography) and vascular stiffness (applanation tonometry) in humans. This study includes a stress management education class for the active control.
Interventions
BEHAVIORALStress Management
An eight week stress reduction course.
Sponsors
Emory University
Texas Tech University
Purdue University
National Heart, Lung, and Blood Institute (NHLBI)
Michigan Technological University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Seated systolic blood pressure \>119 mmHg and/or diastolic blood pressure \>79 mmHg * Body mass index \<30 kg/m2
Exclusion criteria
* Smokers * Diabetes * Pregnant women * History of autonomic dysfunction * Cardiovascular medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Muscle Sympathetic Nerve Activity | Data reported is the change in the mean value from before to after the 8 week intervention (i.e. pre to post). | Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using microneurography. Sympathetic bursts that were at least three times higher than baseline noise were evaluated by a trained investigator and quantified as bursts per minute. The investigator was blinded to the condition and whether the data was pre or post until after all data was collected and analyzed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Arterial Stiffness | Data reported is the change in the mean value from before to after the 8 week intervention (i.e. pre to post). | Carotid-femoral pulse wave velocity using applanation tonometry. A SphygmoCor system was used to gait pulse waves from a tonometer to the R-wave of a 3-lead ECG and carotid to femoral pulse wave velocity was evaluated in meters per second. A higher value indicates more arterial stiffness in the aorta, and a lower value indicates less stiffness in the aorta. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Nocturnal Blood Pressure Dip | Data reported is the change in the mean value from before to after the 8 week intervention (i.e. pre to post). | Change in systolic nocturnal blood pressure during sleep when compared to wakefulness. We used ambulatory blood pressure monitors set to record blood pressures every 30 minutes while the participant was sleeping and every 20 minutes while they were awake for a 24-hour period once before and once after the 8-week intervention. Values reported are the percentage of systolic arterial pressure dipping during sleep compared to wakefulness before vs. after the 8 week intervention. |
Countries
United States
Participant flow
Recruitment details
We screened 180 potential participants for this study between the fall of 2018 through the fall of 2022.
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness-Based Stress Reduction An eight week course specifically designed to improve mindfulness and to reduce stress. | 27 |
| Stress Management Education An eight week program specifically designed to provide education about stress responses in humans, and as an active control for Mindfulness-Based Stress Reduction studies. | 25 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 7 |
| Overall Study | Protocol Violation | 4 | 0 |
Baseline characteristics
| Characteristic | Mindfulness-Based Stress Reduction | Stress Management Education | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants | 25 Participants | 51 Participants |
| Age, Continuous | 26 years STANDARD_DEVIATION 7 | 23 years STANDARD_DEVIATION 3 | 25 years STANDARD_DEVIATION 5 |
| Carotid-femoral pulse wave velocity (arterial stiffness) | 5.55 meters per second STANDARD_DEVIATION 0.81 | 5.38 meters per second STANDARD_DEVIATION 0.82 | 5.47 meters per second STANDARD_DEVIATION 0.81 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 25 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| muscle sympathetic nerve activity (MSNA) | 19.6 bursts per minute STANDARD_DEVIATION 8.8 | 17.7 bursts per minute STANDARD_DEVIATION 5.9 | 18.8 bursts per minute STANDARD_DEVIATION 7.6 |
| Nocturnal systolic blood pressure dipping (%) | 12.65 Percent dipping vs. wakefulness average STANDARD_DEVIATION 7.13 | 12.66 Percent dipping vs. wakefulness average STANDARD_DEVIATION 4.69 | 12.66 Percent dipping vs. wakefulness average STANDARD_DEVIATION 6.12 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 10 Participants | 21 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 2 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 14 Participants | 29 Participants |
| Region of Enrollment United States | 27 participants | 25 participants | 52 participants |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Male | 21 Participants | 21 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 25 |
| other Total, other adverse events | 0 / 27 | 0 / 25 |
| serious Total, serious adverse events | 0 / 27 | 0 / 25 |
Outcome results
Primary
Muscle Sympathetic Nerve Activity
Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using microneurography. Sympathetic bursts that were at least three times higher than baseline noise were evaluated by a trained investigator and quantified as bursts per minute. The investigator was blinded to the condition and whether the data was pre or post until after all data was collected and analyzed.
Time frame: Data reported is the change in the mean value from before to after the 8 week intervention (i.e. pre to post).
Population: We had 21 participants in the spring of 2020 with excellent success on baseline nerve recordings, but with COVID-19 restrictions we were not allowed to bring any participants into the laboratory for post testing. This resulted in the limited sample size of 5 participants in each arm with excellent muscle sympathetic nerve recordings both before and after the 8-week interventions.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness-Based Stress Reduction | Muscle Sympathetic Nerve Activity | -2 bursts per minute | Standard Error 2 |
| Stress Management Education | Muscle Sympathetic Nerve Activity | -1 bursts per minute | Standard Error 2 |
Comparison: Repeated measures analysis of variance with 2 groups (MBSR and SME) and 2 time points (Pre vs. Post). Outcome data reported is the change in the mean number of bursts per minute of muscle sympathetic nerve activity (MSNA) from pre to post.p-value: 0.51ANOVA
Secondary
Arterial Stiffness
Carotid-femoral pulse wave velocity using applanation tonometry. A SphygmoCor system was used to gait pulse waves from a tonometer to the R-wave of a 3-lead ECG and carotid to femoral pulse wave velocity was evaluated in meters per second. A higher value indicates more arterial stiffness in the aorta, and a lower value indicates less stiffness in the aorta.
Time frame: Data reported is the change in the mean value from before to after the 8 week intervention (i.e. pre to post).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness-Based Stress Reduction | Arterial Stiffness | -0.04 meters per second | Standard Deviation 0.94 |
| Stress Management Education | Arterial Stiffness | -0.31 meters per second | Standard Deviation 0.72 |
Comparison: Repeated measures analysis of variance with 2 groups (MBSR and SME) and 2 time points (Pre vs. Post). Outcome data reported is the change in carotid-to-femoral pulse wave velocity in meters per second from pre to post. We had 21 participants in the spring of 2020 that were were not allowed to bring into the laboratory for post testing during COVID-19 restrictions which led to our limited sample size.p-value: 0.25ANOVA
Other Pre-specified
Nocturnal Blood Pressure Dip
Change in systolic nocturnal blood pressure during sleep when compared to wakefulness. We used ambulatory blood pressure monitors set to record blood pressures every 30 minutes while the participant was sleeping and every 20 minutes while they were awake for a 24-hour period once before and once after the 8-week intervention. Values reported are the percentage of systolic arterial pressure dipping during sleep compared to wakefulness before vs. after the 8 week intervention.
Time frame: Data reported is the change in the mean value from before to after the 8 week intervention (i.e. pre to post).
Population: Repeated measures analysis of variance with 2 groups (MBSR and SME) and 2 time points (pre vs. post). Outcome data reported is the change in the mean nighttime systolic blood pressure dipping from pre to post as a percentage. We had 21 participants in the spring of 2020 that we were not allowed to bring into the laboratory for post-testing due to COVID-19 restrictions. We were only able to have participants in that largest cohort complete questionnaire data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness-Based Stress Reduction | Nocturnal Blood Pressure Dip | -3 percent dipping | Standard Error 5 |
| Stress Management Education | Nocturnal Blood Pressure Dip | 1 percent dipping | Standard Error 6 |