Device-guided Breathing Exercises on Blood Pressure in Diabetic Patients

NCT ID: NCT00951119

Last Updated: 2012-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-06-30

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 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

Keywords

type 2 diabetes; hypertension; treatment; non-medical

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

resperate device

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).

Group Type: EXPERIMENTAL

Resperate

Intervention Type: DEVICE

device-guided breathing exercises

control device

Resperate device without slowing of breathing

Group Type: SHAM_COMPARATOR

Resperate

Intervention Type: DEVICE

breathing device without slowing of breathing frequency

Interventions

Resperate

device-guided breathing exercises

Intervention Type: DEVICE

Resperate

breathing device without slowing of breathing frequency

Intervention Type: DEVICE

Eligibility Criteria

Inclusion 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.

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),
• patients with insufficient knowledge of the Dutch language to understand the requirements of the study,
• additional criteria were hospitalization in the past 3 months, deafness, blindness and cognitive abilities deemed insufficient for operation of a study device.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Research Foundation, The Netherlands

OTHER

Sponsor Role: lead

Responsible Party

Nanne Kleefstra

Prof. dr. Bilo and N. Kleefstra

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

HEnk J.G. Bilo, MD, PhD, Professor, FRCP

Role: STUDY_DIRECTOR

Diabetes centre, isala clinics

Locations

Isala Clinics, Diabetes Centre

Zwolle, , Netherlands

Isala clinics

Zwolle, , Netherlands

Countries

Netherlands

Other Identifiers

Reperate3

Identifier Type: -

Identifier Source: org_study_id