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Behavioral Neurocardiac Training and Hypertension

NCT ID: NCT00811811

Last Updated: 2008-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Keywords

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Hypertension Biofeedback Relaxation training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Behavioral neurocardiac training

Group Type EXPERIMENTAL

Behavioral neurocardiac training

Intervention Type BEHAVIORAL

6 training sessions scheduled over 8 weeks

2

Autogenic relaxation training

Group Type ACTIVE_COMPARATOR

Autogenic relaxation training

Intervention Type BEHAVIORAL

6 training sessions scheduled over 8 weeks

Interventions

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Behavioral neurocardiac training

6 training sessions scheduled over 8 weeks

Intervention Type BEHAVIORAL

Autogenic relaxation training

6 training sessions scheduled over 8 weeks

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Unilever R&D

INDUSTRY

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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University Health Network

Principal Investigators

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Robert P Nolan, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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Toronto General Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 20194302 (View on PubMed)

Other Identifiers

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04-516-BE

Identifier Type: -

Identifier Source: org_study_id