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临床试验/NCT00811811
NCT00811811已完成不适用

Behavioral Neurocardiac Training With Biofeedback Augments Vagal-Heart Rate Modulation and Baroreflex Sensitivity Among Patients With Hypertension

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2005年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
2
主要终点
Ambulatory daytime and 24-hour systolic blood pressure, diastolic blood pressure, and pulse pressure.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
35 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

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

时间窗: Baseline and Post-treatment (following 6 treatment sessions scheduled over an 8-week interval)

次要结局

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

研究者

申办方类型
Other

研究点 (2)

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