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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| resperate device | Experimental | 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). |
|
| control device | Sham Comparator | Resperate device without slowing of breathing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resperate | Device | device-guided breathing exercises |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The effect of the breathing device on SBP is the main study parameter | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary endpoints include diastolic blood pressure (DBP) and quality of life. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HEnk J.G. Bilo, MD, PhD, Professor, FRCP | Diabetes centre, isala clinics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isala Clinics, Diabetes Centre | Zwolle | 8000 GM | Netherlands | |||
| Isala clinics |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Resperate |
| Device |
breathing device without slowing of breathing frequency |
|
| Zwolle |
| 8000 GM |
| Netherlands |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |