MedTrace Logo

RCT of Effects of Device-guided Breathing on Ambulatory BP

NCT01184755 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 253

Last updated 2017-05-16

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

BEHAVIORAL

Relaxation

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).

DEVICE

RESPeRate

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Rutgers, The State University of New Jersey

    lead OTHER

Principal Investigators

  • Lynn P Clemow, PhD · Rutgers, The State University of New Jersey

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01184755 on ClinicalTrials.gov