Mindfulness and Neural Cardiovascular Control in Humans

Randomized, Active-Control Study to Determine the Effect of Mindfulness-Based Stress Reduction on Sympathetic Activity and Arterial Stiffness

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.

Study Overview

• Status: Completed
• Conditions: Elevated Blood Pressure
• Intervention / Treatment: Behavioral: Stress Management

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Hammond, Indiana, United States, 46323
      • Purdue University Northwest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-Based Stress Reduction; An 8-week program specifically designed to improve mindfulness and to reduce stress.	Behavioral: Stress Management; An eight week stress reduction course.
Active Comparator: Stress Management Education; 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.	Behavioral: Stress Management; An eight week stress reduction course.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	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).

Other Outcome Measures

Outcome Measure	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.	Data reported is the change in the mean value from before to after the 8 week intervention (i.e. pre to post).

Collaborators and Investigators

• Sponsor: Michigan Technological University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Emory University; Texas Tech University; Purdue University
• Investigators: Principal Investigator: John Durocher, PhD, Purdue University Northwest Biological Sciences

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2018
• Primary Completion (Actual): November 23, 2022
• Study Completion (Actual): January 31, 2023

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: M1690; 1R15HL140596-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No