Clinical trial NCT01184755: RCT of Effects of Device-guided Breathing on Ambulatory BP
Official title: RCT of Device-guided Breathing Effects on Ambulatory BP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Device-guided breathing
hypertension
behavioral intervention
stress reduction
Heart Rate Variability (HRV) biofeedback
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-08-19
Enrollment: 253
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our aim is to conduct a randomized controlled trial (RCT) to test the efficacy of a guided breathing intervention on ambulatory blood pressure (ABP), both systolic and diastolic BP. There are 3 groups: 1) Intervention group instructed to use the RESPeRate device that guides the breath into the 6 breaths/minute range daily for 8 weeks. 2) Relaxation control condition (using a modified device to guide breathing at 13 breaths/minute rate); and 3) Usual Care (UC). After the initial 8 week trial, the main outcome, the intervention group will be randomly assigned to stop using the RESPeRate device or to continue using it for 8 more weeks.

Detailed description: Device-guided breathing is a behavioral intervention that guides the breathing into the 6 per minute range, inducing respiratory sinus arrythmia (RSA), which is the natural cycle of arrythmia that occurs through the influence of breathing on the flow of sympathetic and vagus impulses to the sinoatrial node of the heart. It has been shown in several small trials to have substantial effects on BP reduction, has no known side-effects, and may represent a cost-effective adjunctive treatment for hypertension. an important consideration is that, often, behavioral interventions are given for a brief amount of time, but are expected to have long-term effects. This does not hold true for medication; one would not give anti-hypertensive medication for eight weeks and expect an effect on BP several months later. The development of behavioral interventions needs to take into account methods to sustain long-term effects.

Our aim is to conduct a randomized controlled trial (RCT) to test the efficacy of a guided breathing intervention on ambulatory BP (ABP) in hypertensives drawn from primary care and specialty hypertension practices, using a sample size powered to detect effects at 8 weeks and 4-month follow-up. The design calls for two control groups: Usual Care (UC) and a relaxation control condition (using a device that gives the same type of feedback sounds as the guided breathing feedback device, but modified to pace the breathing at approximately 13 breaths per minute, a normal resting rate.) The intervention condition has participants use the RESPeRate device that guides the breath into the 6 breaths/minute range. The initial intervention lasts eight weeks, following which participants are further randomized to either: 1) ending the intervention; of 2) continuing the intervention for the next 8 weeks. The main outcomes are the change at 8 weeks in systolic and diastolic BP (measured by Ambulatory BP monitoring) during the waking hours. Outcomes are measured at baseline, 8 weeks, and 16 weeks. The primary outcomes are BP results at 8 weeks, with a 3-group comparison of the intervention group, the relaxation control group and usual care.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Hypertension
* Treated with at least one antihypertensive drug
* BP still not controlled (\>135/85 on Ambulatory BP waking average)

Exclusion Criteria:

* Diabetes
* Atrial Fibrillation
* Pregnancy

Primary outcomes:
measure: Change in Systolic and Diastolic BP Measured by Ambulatory BP Monitoring (Waking Averages)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: UMDNJ - Robert Wood Johnson Medical School
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Lynn P Clemow, PhD
role: PRINCIPAL_INVESTIGATOR
References: