N/A
Completed N=253
RCT of Effects of Device-guided Breathing on Ambulatory BP
Source: ClinicalTrials.gov NCT01184755 ↗Enrolled (actual)
253
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Change in Systolic and Diastolic BP Measured by Ambulatory BP Monitoring (Waking Averages) — 5.8; 6.6; 1.2; 4.0 mm Hg — p=.01
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Systolic and Diastolic BP Measured by Ambulatory BP Monitoring (Waking Averages) |
5.8; 6.6; 1.2; 4.0; 4.7; 0.5 | .01 sig |
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
Data sourced from ClinicalTrials.gov (NCT01184755). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.