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| ID | Type | Description | Link |
|---|---|---|---|
| 1R15HL140596-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Emory University | OTHER |
| Texas Tech University | OTHER |
| Purdue University | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Based Stress Reduction | Experimental | An 8-week program specifically designed to improve mindfulness and to reduce stress. |
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| Stress Management Education | Active Comparator | An 8-week program specifically designed to provide education about stress responses in humans, and as an active control for Mindfulness-Based Stress Reduction studies. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stress Management | Behavioral | An eight week stress reduction course. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Data reported is the change in the mean value from before to after the 8 week intervention (i.e. pre to post). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Data reported is the change in the mean value from before to after the 8 week intervention (i.e. pre to post). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Durocher, PhD | Purdue University Northwest Biological Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Purdue University Northwest | Hammond | Indiana | 46323 | United States |
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We screened 180 potential participants for this study between the fall of 2018 through the fall of 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness-Based Stress Reduction | An eight week course designed to increase mindfulness and to decrease stress. Participants met with an MBSR expert once each week for 2.5 hours and had at-home practice assignments for 45 minutes per day which included mindfulness, breathing, and gently yoga exercises. |
| FG001 | Stress Management Education | An eight week stress education course designed to be an active control for mindfulness-based stress reduction studies. Participants met for 2.5 hours each week to be educated about stress responses, benefits of gentle resistance training, and other topics such as the benefits of volunteering. Participants completed at-home sessions for 45-minutes each day that included reading from "Why Zebra's Don't Get Ulcers" and they could also perform gentle resistance training with a resistance band kit that was provided. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness-Based Stress Reduction | An eight week course specifically designed to improve mindfulness and to reduce stress. |
| BG001 | 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. |
| 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, Categorical | Count of Participants |
| 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 | 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. | 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. | Posted | Mean | Standard Error | bursts per minute | Data reported is the change in the mean value from before to after the 8 week intervention (i.e. pre to post). |
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Participants were randomized into an 8-week mindfulness-based stress reduction OR 8-week stress management education intervention. We pre-tested participants within a week of starting the interventions, and then post-tested them within a week of completing the interventions. Thus, each participant was monitored for a period of 10 weeks.
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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 | Mindfulness-Based Stress Reduction | An eight week program specifically designed to improve mindfulness and to reduce stress. |
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In spring 2020 we had 21 participants enrolled, and we shifted the MBSR and SME courses to Zoom for the final 4 weeks of each intervention. We were able to send out questionnaires to participants for post testing, but we were not allowed to post-test anyone in the lab for our three specific aims related to blood pressure dipping, MSNA, or arterial stiffness due to COVID-19 restrictions. The original PI moved to a new position in the summer of 2020 which provided some additional complications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly Kallio, Assistant Vice President of Sponsored Programs | Michigan Technological University | 9064872226 | kmkallio@mtu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 23, 2021 | Sep 27, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Purdue Consent Form | Feb 23, 2021 | Sep 24, 2024 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Michigan Tech Original Consent Form | Jul 24, 2018 | Sep 24, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| NIH |
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| Data reported is the change in the mean value from before to after the 8 week intervention (i.e. pre to post). |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| muscle sympathetic nerve activity (MSNA) | Obtaining clear recordings of muscle sympathetic nerve activity is difficult and we cannot always obtain a clear signal with distinct bursts in all participants. Some participants elect not to have this measurement performed because it is invasive and can cause some temporary discomfort. | Mean | Standard Deviation | bursts per minute |
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| Carotid-femoral pulse wave velocity (arterial stiffness) | Mean | Standard Deviation | meters per second |
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| Nocturnal systolic blood pressure dipping (%) | We have only included participants with more than 80% successful wake and sleep measurements of ambulatory blood pressure. Three readings an hour were taken during wakefulness and two readings per hour were taken during sleep. Some participants did not keep the ambulatory monitor on during the entire recording period and others did not have the required percentage of successful recordings. | Mean | Standard Deviation | Percent dipping vs. wakefulness average |
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An eight week course specifically designed to improve mindfulness and to reduce stress. |
| OG001 | 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. |
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| 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. | Posted | Mean | Standard Deviation | meters per second | Data reported is the change in the mean value from before to after the 8 week intervention (i.e. pre to post). |
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| 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. | 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. | Posted | Mean | Standard Error | percent dipping | Data reported is the change in the mean value from before to after the 8 week intervention (i.e. pre to post). |
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| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | 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. | 0 | 25 | 0 | 25 | 0 | 25 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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