Trial Outcomes & Findings for Mindfulness and Neural Cardiovascular Control in Humans (NCT NCT03626363)
NCT ID: NCT03626363
Last Updated: 2024-11-08
Results Overview
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.
COMPLETED
NA
52 participants
Data reported is the change in the mean value from before to after the 8 week intervention (i.e. pre to post).
2024-11-08
Participant Flow
We screened 180 potential participants for this study between the fall of 2018 through the fall of 2022.
Participant milestones
| Measure |
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.
|
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.
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|---|---|---|
|
Overall Study
STARTED
|
27
|
25
|
|
Overall Study
COMPLETED
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
5
|
7
|
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Mindfulness-Based Stress Reduction
n=27 Participants
An eight week course specifically designed to improve mindfulness and to reduce stress.
|
Stress Management Education
n=25 Participants
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.
|
Total
n=52 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
|
1 Participants
n=27 Participants
|
0 Participants
n=25 Participants
|
1 Participants
n=52 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=27 Participants
|
25 Participants
n=25 Participants
|
51 Participants
n=52 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=27 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=52 Participants
|
|
Age, Continuous
|
26 years
STANDARD_DEVIATION 7 • n=27 Participants
|
23 years
STANDARD_DEVIATION 3 • n=25 Participants
|
25 years
STANDARD_DEVIATION 5 • n=52 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=27 Participants
|
4 Participants
n=25 Participants
|
10 Participants
n=52 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=27 Participants
|
21 Participants
n=25 Participants
|
42 Participants
n=52 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=27 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=52 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=27 Participants
|
25 Participants
n=25 Participants
|
52 Participants
n=52 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=27 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=52 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=27 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=27 Participants
|
10 Participants
n=25 Participants
|
21 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=27 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=27 Participants
|
1 Participants
n=25 Participants
|
2 Participants
n=52 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=27 Participants
|
14 Participants
n=25 Participants
|
29 Participants
n=52 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=27 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=52 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=27 Participants
|
0 Participants
n=25 Participants
|
0 Participants
n=52 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=27 Participants
|
25 participants
n=25 Participants
|
52 participants
n=52 Participants
|
|
muscle sympathetic nerve activity (MSNA)
|
19.6 bursts per minute
STANDARD_DEVIATION 8.8 • n=18 Participants • 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.
|
17.7 bursts per minute
STANDARD_DEVIATION 5.9 • n=14 Participants • 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.
|
18.8 bursts per minute
STANDARD_DEVIATION 7.6 • n=32 Participants • 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.
|
|
Carotid-femoral pulse wave velocity (arterial stiffness)
|
5.55 meters per second
STANDARD_DEVIATION 0.81 • n=27 Participants
|
5.38 meters per second
STANDARD_DEVIATION 0.82 • n=25 Participants
|
5.47 meters per second
STANDARD_DEVIATION 0.81 • n=52 Participants
|
|
Nocturnal systolic blood pressure dipping (%)
|
12.65 Percent dipping vs. wakefulness average
STANDARD_DEVIATION 7.13 • n=20 Participants • 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.
|
12.66 Percent dipping vs. wakefulness average
STANDARD_DEVIATION 4.69 • n=15 Participants • 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.
|
12.66 Percent dipping vs. wakefulness average
STANDARD_DEVIATION 6.12 • n=35 Participants • 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.
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Mindfulness-Based Stress Reduction
n=5 Participants
An eight week course specifically designed to improve mindfulness and to reduce stress.
|
Stress Management Education
n=5 Participants
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.
|
|---|---|---|
|
Muscle Sympathetic Nerve Activity
|
-2 bursts per minute
Standard Error 2
|
-1 bursts per minute
Standard Error 2
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Mindfulness-Based Stress Reduction
n=10 Participants
An eight week course specifically designed to improve mindfulness and to reduce stress.
|
Stress Management Education
n=12 Participants
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.
|
|---|---|---|
|
Arterial Stiffness
|
-0.04 meters per second
Standard Deviation 0.94
|
-0.31 meters per second
Standard Deviation 0.72
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Mindfulness-Based Stress Reduction
n=3 Participants
An eight week course specifically designed to improve mindfulness and to reduce stress.
|
Stress Management Education
n=4 Participants
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.
|
|---|---|---|
|
Nocturnal Blood Pressure Dip
|
-3 percent dipping
Standard Error 5
|
1 percent dipping
Standard Error 6
|
Adverse Events
Mindfulness-Based Stress Reduction
Stress Management Education
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kelly Kallio, Assistant Vice President of Sponsored Programs
Michigan Technological University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place