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| Name | Class |
|---|---|
| Unilever R&D | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Behavioral neurocardiac training |
|
| 2 | Active Comparator | Autogenic relaxation training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral neurocardiac training | Behavioral | 6 training sessions scheduled over 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| RR interval, vagal-heart rate modulation (high frequency power in RR interval variability [0.15-0.40 Hz/ms2]) and baroreflex sensitivity | 8 weeks |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert P Nolan, Ph.D. | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20194302 | Derived | 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. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001326 | Autogenic Training |
| ID | Term |
|---|---|
| D006990 | Hypnosis |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Autogenic relaxation training |
| Behavioral |
6 training sessions scheduled over 8 weeks |
|
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |