NCT03626363

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

September 4, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

November 8, 2024

Completed
Last Updated

November 8, 2024

Status Verified

November 1, 2024

Enrollment Period

4.2 years

First QC Date

August 8, 2018

Results QC Date

April 15, 2024

Last Update Submit

November 6, 2024

Conditions

Elevated Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Arterial Stiffness

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

Other Outcomes (1)

  • 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).

Study Arms (2)

Mindfulness-Based Stress Reduction

EXPERIMENTAL

An 8-week program specifically designed to improve mindfulness and to reduce stress.

Behavioral: Stress Management

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.

Behavioral: Stress Management

Interventions

Stress ManagementBEHAVIORAL

An eight week stress reduction course.

Mindfulness-Based Stress ReductionStress Management Education

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Seated systolic blood pressure \>119 mmHg and/or diastolic blood pressure \>79 mmHg
  • Body mass index \<30 kg/m2

You may not qualify if:

  • Smokers
  • Diabetes
  • Pregnant women
  • History of autonomic dysfunction
  • Cardiovascular medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Purdue University Northwest

Hammond, Indiana, 46323, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Limitations and Caveats

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.

Results Point of Contact

Title
Kelly Kallio, Assistant Vice President of Sponsored Programs
Organization
Michigan Technological University
kmkallio@mtu.edu
9064872226

Study Officials

  • John Durocher, PhD

    Purdue University Northwest Biological Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2018

First Posted

August 13, 2018

Study Start

September 4, 2018

Primary Completion

November 23, 2022

Study Completion

January 31, 2023

Last Updated

November 8, 2024

Results First Posted

November 8, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)