Hypertension
Conditions
Keywords
Device-guided breathing, hypertension, behavioral intervention, stress reduction, Heart Rate Variability (HRV) biofeedback
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.
Interventions
BEHAVIORALRelaxation
Participants are instructed to use the modified device (which paces the breath at a constant 13 breaths/minute) daily for 15 minutes (timing set automatically by device).
DEVICERESPeRate
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic and Diastolic BP Measured by Ambulatory BP Monitoring (Waking Averages) | 8 weeks | The primary outcome for this study is the change in systolic and diastolic BP measured by Ambulatory BP monitoring at 8-weeks. The measure is the waking mean BP. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Resperate Device Used for 8 Weeks Participants to use Resperate device to guide breathing for 8 weeks, then not used for next 8 weeks
Device-guided breathing: Participants instructed to practice daily for 15 minutes (guided and timed by the device used at home)
RESPeRate | 126 |
| Relaxation Placebo Device Participants use modified device to pace breathing in the 13/minute range for daily practice for 8 weeks and no device thereafter
Relaxation: Participants are instructed to use the device (which paces the breath at a constant 13 breaths/minute) daily for 15 minutes (timing set automatically by device).
Sham RESPeRate | 65 |
| Usual Care Participants continue their usual medication and other management for their hypertension. All participants (including UC) are given a home BP monitor and asked to take their BP in morning and evening 3 days/week. | 62 |
| Total | 253 |
Baseline characteristics
| Characteristic | Relaxation Placebo Device | Usual Care | Resperate Device Used for 8 Weeks | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 11 Participants | 25 Participants | 50 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 51 Participants | 101 Participants | 203 Participants |
| Age, Continuous | 57.58 years | 56.34 years | 56.65 years | 56.74 years |
| Region of Enrollment United States | 65 participants | 62 participants | 126 participants | 253 participants |
| Sex: Female, Male Female | 33 Participants | 34 Participants | 71 Participants | 138 Participants |
| Sex: Female, Male Male | 32 Participants | 28 Participants | 55 Participants | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 126 | 0 / 65 | 0 / 62 |
| serious Total, serious adverse events | 0 / 126 | 0 / 65 | 0 / 62 |
Outcome results
Primary
Change in Systolic and Diastolic BP Measured by Ambulatory BP Monitoring (Waking Averages)
The primary outcome for this study is the change in systolic and diastolic BP measured by Ambulatory BP monitoring at 8-weeks. The measure is the waking mean BP.
Time frame: 8 weeks
Population: These were patients who completed both the baseline and 8-week Ambulatory BP measures.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Resperate Device Used for 8 Weeks | Change in Systolic and Diastolic BP Measured by Ambulatory BP Monitoring (Waking Averages) | Change in Diastolic BP | 4.0 mm Hg | Standard Deviation 7 |
| Resperate Device Used for 8 Weeks | Change in Systolic and Diastolic BP Measured by Ambulatory BP Monitoring (Waking Averages) | Change in Systolic BP | 5.8 mm Hg | Standard Deviation 10.7 |
| Relaxation Placebo Device | Change in Systolic and Diastolic BP Measured by Ambulatory BP Monitoring (Waking Averages) | Change in Diastolic BP | 4.7 mm Hg | Standard Deviation 7.4 |
| Relaxation Placebo Device | Change in Systolic and Diastolic BP Measured by Ambulatory BP Monitoring (Waking Averages) | Change in Systolic BP | 6.6 mm Hg | Standard Deviation 12.3 |
| Usual Care | Change in Systolic and Diastolic BP Measured by Ambulatory BP Monitoring (Waking Averages) | Change in Systolic BP | 1.2 mm Hg | Standard Deviation 9.9 |
| Usual Care | Change in Systolic and Diastolic BP Measured by Ambulatory BP Monitoring (Waking Averages) | Change in Diastolic BP | 0.5 mm Hg | Standard Deviation 7.1 |
Comparison: This is the change in Systolic BP at 8 weeksp-value: 0.0195% CI: [-0.987999, -0.134513]Mixed effects regression analysis
Comparison: This is the analysis of change in diastolic BP from Ambulatory BP monitoring.p-value: 0.00695% CI: [-0.667312, -0.115079]mixed effects regression analysis