Behavioral Neurocardiac Training and Hypertension

Not Applicable

Completed

• Conditions: Hypertension
• Interventions: Behavioral: Behavioral neurocardiac training; Behavioral: Autogenic relaxation training

• Registration Number: NCT00811811
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Primary Completion: 2006-08
• Study Completion: 2007-12
• Status Verified: 2008-12
• Study First Submitted: 2008-12-18
• Study First Submitted QC: 2008-12-18
• Last Update Submitted: 2008-12-18
• Study First Posted: 2008-12-19
• Last Update Posted: 2008-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Behavioral neurocardiac training	Behavioral neurocardiac training
2	Autogenic relaxation training	Autogenic relaxation training

Primary Outcome Measures

Name	Time	Method
Ambulatory daytime and 24-hour systolic blood pressure, diastolic blood pressure, and pulse pressure.	Baseline and Post-treatment (following 6 treatment sessions scheduled over an 8-week interval)

Secondary Outcome Measures

Name	Time	Method
RR interval, vagal-heart rate modulation (high frequency power in RR interval variability [0.15-0.40 Hz/ms2]) and baroreflex sensitivity	8 weeks

Trial Locations

Locations (1)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada