The effect of device-guided breathing exercises on blood pressure in diabetic patients with hypertension;A randomized, double-blind controlled trial
- Conditions
- hypertension / high blood pressure10057166
- Registration Number
- NL-OMON33106
- Lead Sponsor
- diabetes kennis centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 48
Patients are required to meet the following 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 according to the method described below.
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) will be excluded. Patients with insufficient knowledge of the Dutch language to understand the requirements of the study will be excluded. Additional criteria were hospitalization in the past 3 months, deafness, blindness and cognitive abilities deemed insufficient for operation of a study device
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameters/endpoints: The effect of the breathing device on SBP is<br /><br>the main study parameter. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints include diastolic blood pressure (DBP).</p><br>