An interventional study of Behavioral neurocardiac training and Autogenic relaxation training in Hypertension, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 35 Years to 64 Years. Per ClinicalTrials.gov, last updated 2008-12-19.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Prevention
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 65 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.
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Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
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Exclusion criteria:
Behavioral neurocardiac training
Behavioral: Behavioral neurocardiac training
Autogenic relaxation training
Behavioral: Autogenic relaxation training
6 training sessions scheduled over 8 weeks
6 training sessions scheduled over 8 weeks
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)
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
This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto