Device-guided Breathing Exercises on Blood Pressure in Diabetic Patients

NCT00951119 | Completed Phase 3

• 1 other identifier: Reperate3
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• The effect of the breathing device on SBP is the main study parameter

  8 weeks

Secondary Outcomes (1)

• Secondary endpoints include diastolic blood pressure (DBP) and quality of life.

  8 weeks

Study Arms (2)

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).

Device: Resperate

control device

SHAM COMPARATOR

Resperate device without slowing of breathing

Device: Resperate

Interventions

Resperate DEVICE

device-guided breathing exercises

resperate device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical Research Foundation, The Netherlands: lead

Study Sites (2)

Isala Clinics, Diabetes Centre

Zwolle, 8000 GM, Netherlands

Location

Isala clinics

Zwolle, 8000 GM, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

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

  Diabetes centre, isala clinics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. Bilo and N. Kleefstra

Study Record Dates

• First Submitted: August 3, 2009
• First Posted: August 4, 2009
• Study Start: September 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 24, 2012

Record last verified: 2012-10

Locations

NL (2)