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.
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: The effect of the breathing device on SBP is
the main study parameter.
Secondary outcome
Secondary endpoints include diastolic blood pressure (DBP).
Background summary
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. Our 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, we want
to perform a randomized, double-blind, controlled trial in a population of T2DM
patients.
Study objective
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
Study design: A randomized, double-blind, controlled trial.
Intervention
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.
Study burden and risks
not to be expected
dokter van Heesweg 2
8025 AB Zwolle
Nederland
dokter van Heesweg 2
8025 AB Zwolle
Nederland
Listed location countries
Age
Inclusion criteria
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.
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) 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL28100.075.09 |