Mindfulness and Neural Cardiovascular Control in Humans

NCT ID: NCT03626363

Last Updated: 2024-11-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-04

Study Completion Date

2023-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Elevated Blood Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Mindfulness-Based Stress Reduction

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

Group Type EXPERIMENTAL

Stress Management

Intervention Type BEHAVIORAL

An eight week stress reduction course.

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.

Group Type ACTIVE_COMPARATOR

Stress Management

Intervention Type BEHAVIORAL

An eight week stress reduction course.

Interventions

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Stress Management

An eight week stress reduction course.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Emory University

OTHER

Sponsor Role collaborator

Texas Tech University

OTHER

Sponsor Role collaborator

Purdue University

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Michigan Technological University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Durocher, PhD

Role: PRINCIPAL_INVESTIGATOR

Purdue University Northwest Biological Sciences

Locations

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Purdue University Northwest

Hammond, Indiana, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Purdue Consent Form

View Document

Document Type: Informed Consent Form: Michigan Tech Original Consent Form

View Document

Other Identifiers

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1R15HL140596-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

M1690

Identifier Type: -

Identifier Source: org_study_id

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