Reperate3: Device-guided Breathing Exercises on Blood Pressure in Diabetic Patients

Sponsor

Medical Research Foundation, The Netherlands (Other)

Overall Status

Completed

CT.gov ID

NCT00951119

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Rationale: Hypertension is an important risk factor of cardiovascular disease, especially in patients with type 2 diabetes mellitus (T2DM). A relatively recent development for the treatment of hypertension is the use of breathing exercises. The investigators' previous studies with a breathing device did not show any positive results. However, these studies and other trials investigating the effects of breathing devices had not a double-blind design. Therefore, the investigators want to perform a randomized, double-blind, controlled trial in a population of T2DM patients.

Objective: To determine the effect of a device slowing breathing (Resperate©) on office systolic blood pressure (SBP) in diabetic patients with treated hypertension with moderate BP control.

Study design: A randomized, double-blind, controlled trial.

Study population: Patients with type 2 diabetes mellitus, over 18 years old and a baseline systolic blood pressure between 140-160 mm Hg.

Intervention: One group receives treatment with a breathing device (Resperate©) and the other group receives treatment with a "control" breathing device. The latter device does not try to alter the breathing pattern.

Main study parameters/endpoints: The effect of the breathing device on SBP is the main study parameter. Secondary endpoints include diastolic blood pressure (DBP) and quality of life.

Condition or Disease	Intervention/Treatment	Phase
Hypertension in Type 2 Diabetes	Device: Resperate Device: Resperate	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effect of Device-guided Breathing Exercises on Blood Pressure in Diabetic Patients With Hypertension (Resperate-3) A Randomized, Double-blind Controlled Trial

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: resperate device Resperate© is a device that helps to slow down breathing. This device can measure the breathing patterns through a breathing sensor mounted on the upper abdomen or chest. Furthermore, music-like sound patterns can be composed similar to this breathing pattern, which the patient can hear through the headphones of the Resperate©. By prolonging the expiration, which can be voluntarily used by the user, the frequency of respiration can be slowed down and become more stable (aim"<10 breathings per minute).	Device: Resperate device-guided breathing exercises
Sham Comparator: control device Resperate device without slowing of breathing	Device: Resperate breathing device without slowing of breathing frequency

Arm

Intervention/Treatment

Experimental: resperate device

Resperate© is a device that helps to slow down breathing. This device can measure the breathing patterns through a breathing sensor mounted on the upper abdomen or chest. Furthermore, music-like sound patterns can be composed similar to this breathing pattern, which the patient can hear through the headphones of the Resperate©. By prolonging the expiration, which can be voluntarily used by the user, the frequency of respiration can be slowed down and become more stable (aim"<10 breathings per minute).

Device: Resperate

device-guided breathing exercises

Sham Comparator: control device

Resperate device without slowing of breathing

Device: Resperate

breathing device without slowing of breathing frequency

Outcome Measures

Primary Outcome Measures

The effect of the breathing device on SBP is the main study parameter [8 weeks]

Secondary Outcome Measures

Secondary endpoints include diastolic blood pressure (DBP) and quality of life. [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

known T2DM,
over 18 years old,
known hypertension with a systolic BP (SBP) between 130-170 mm Hg at the previous visit to the internal outpatient department and at the last visit to the internist (which is the same day as baseline measurement) and treated with one or more anti-hypertensive drugs, which have not been changed for the preceding three months. At baseline the SBP should be between 140-160 mm Hg, measured by the investigator.

Exclusion Criteria:

patients with orthostatic hypotension,
known heart failure (NYHA III-IV) and/or patients with pulmonary disease (for example asthma, chronic obstructive pulmonary disease and pulmonary fibrosis),
patients with insufficient knowledge of the Dutch language to understand the requirements of the study,
additional criteria were hospitalization in the past 3 months, deafness, blindness and cognitive abilities deemed insufficient for operation of a study device.