NCT00951119

Device-guided Breathing Exercises on Blood Pressure in Diabetic Patients

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Medical Research Foundation, The Netherlands · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension in Type 2 Diabetes

Interventions

Type	Name	Description
DEVICE	Resperate	device-guided breathing exercises
DEVICE	Resperate	breathing device without slowing of breathing frequency

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-05-01
• Completion: 2012-06-01
• First posted: 2009-08-04
• Last updated: 2012-10-24

Locations

2 sites across 1 country: Netherlands