Ignite Creation Date:
2024-05-05 @ 9:43 PM
Last Modification Date:
2024-10-26 @ 10:08 AM
Study NCT ID:
NCT00951119
Status:
COMPLETED
Last Update Posted:
2012-10-24
First Post:
2009-08-03
Brief Title:
Device-guided Breathing Exercises on Blood Pressure in Diabetic Patients
Sponsor:
Medical Research Foundation The Netherlands
Organization:
Medical Research Foundation The Netherlands
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Reperate3
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 parametersendpoints The effect of the breathing device on SBP is the main study parameter Secondary endpoints include diastolic blood pressure DBP and quality of life
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 parametersendpoints The effect of the breathing device on SBP is the main study parameter Secondary endpoints include diastolic blood pressure DBP and quality of life
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None