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Behavioral Neurocardiac Training and Hypertension

Primary Purpose

Hypertension

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Behavioral neurocardiac training
Autogenic relaxation training
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertension focused on measuring Hypertension, Biofeedback, Relaxation training

Eligibility Criteria

35 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • 35 to 64 years of age
  • diagnosis of Grade 1 or 2 hypertension (140-159 mmHg or 160-180 mmHg SBP; or 90-99 or 100-110 mmHg DBP, respectively).
  • among subjects not prescribed medication, hypertension confirmed by ambulatory BP monitoring: mean 24-hour SBP > 130 mmHg or DBP > 80 mmHg.
  • subjects prescribed antihypertensive pharmacotherapy are required to have a treatment regimen that was unchanged for at least 4 months prior to enrollment.

Exclusion criteria:

  • diagnosis of cardiovascular disease, clinically significant arrhythmia, sleep disorder, psychiatric illness (eg. psychosis), alcohol/drug dependence within the previous year, or an inability to comprehend English or French

Sites / Locations

  • Toronto General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Behavioral neurocardiac training

Autogenic relaxation training

Outcomes

Primary Outcome Measures

Ambulatory daytime and 24-hour systolic blood pressure, diastolic blood pressure, and pulse pressure.

Secondary Outcome Measures

RR interval, vagal-heart rate modulation (high frequency power in RR interval variability [0.15-0.40 Hz/ms2]) and baroreflex sensitivity

Full Information

First Posted
December 18, 2008
Last Updated
December 18, 2008
Sponsor
University Health Network, Toronto
Collaborators
Unilever R&D
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1. Study Identification

Unique Protocol Identification Number
NCT00811811
Brief Title
Behavioral Neurocardiac Training and Hypertension
Official Title
Behavioral Neurocardiac Training With Biofeedback Augments Vagal-Heart Rate Modulation and Baroreflex Sensitivity Among Patients With Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto
Collaborators
Unilever R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This randomized controlled trial will examine whether behavioral neurocardiac training with heart rate variability biofeedback (BNT) augments reduction in ambulatory daytime and 24-hour SBP, DBP and PP, in comparison to an active control intervention (AC, autogenic relaxation training), among subjects diagnosed with hypertension, and following adjustment for medications. In addition, the independent association between the BNT and AC interventions on vagal-heart rate modulation and baroreflex sensitivity will be evaluated during a standardized assessment protocol of mental stress testing. This study extends a previous trial conducted at the UHN, in which we reported that the biofeedback intervention independently augments vagal-heart rate modulation, while reducing symptoms of stress and depressed mood, among subjects diagnosed with cardiovascular disease. Exploratory features of this trial will examine the association between ambulatory blood pressure, vagal-heart rate modulation, baroreflex sensitivity, and markers of inflammatory activity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Hypertension, Biofeedback, Relaxation training

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Behavioral neurocardiac training
Arm Title
2
Arm Type
Active Comparator
Arm Description
Autogenic relaxation training
Intervention Type
Behavioral
Intervention Name(s)
Behavioral neurocardiac training
Intervention Description
6 training sessions scheduled over 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
Autogenic relaxation training
Intervention Description
6 training sessions scheduled over 8 weeks
Primary Outcome Measure Information:
Title
Ambulatory daytime and 24-hour systolic blood pressure, diastolic blood pressure, and pulse pressure.
Time Frame
Baseline and Post-treatment (following 6 treatment sessions scheduled over an 8-week interval)
Secondary Outcome Measure Information:
Title
RR interval, vagal-heart rate modulation (high frequency power in RR interval variability [0.15-0.40 Hz/ms2]) and baroreflex sensitivity
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: 35 to 64 years of age diagnosis of Grade 1 or 2 hypertension (140-159 mmHg or 160-180 mmHg SBP; or 90-99 or 100-110 mmHg DBP, respectively). among subjects not prescribed medication, hypertension confirmed by ambulatory BP monitoring: mean 24-hour SBP > 130 mmHg or DBP > 80 mmHg. subjects prescribed antihypertensive pharmacotherapy are required to have a treatment regimen that was unchanged for at least 4 months prior to enrollment. Exclusion criteria: diagnosis of cardiovascular disease, clinically significant arrhythmia, sleep disorder, psychiatric illness (eg. psychosis), alcohol/drug dependence within the previous year, or an inability to comprehend English or French
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert P Nolan, Ph.D.
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20194302
Citation
Nolan RP, Floras JS, Harvey PJ, Kamath MV, Picton PE, Chessex C, Hiscock N, Powell J, Catt M, Hendrickx H, Talbot D, Chen MH. Behavioral neurocardiac training in hypertension: a randomized, controlled trial. Hypertension. 2010 Apr;55(4):1033-9. doi: 10.1161/HYPERTENSIONAHA.109.146233. Epub 2010 Mar 1.
Results Reference
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Behavioral Neurocardiac Training and Hypertension

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