Device-guided Breathing Exercises on Blood Pressure in Diabetic Patients (Reperate3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nanne Kleefstra, Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier:
NCT00951119
First received: August 3, 2009
Last updated: October 23, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Hypertension in Type 2 Diabetes
Device: Resperate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Device-guided Breathing Exercises on Blood Pressure in Diabetic Patients With Hypertension (Resperate-3) A Randomized, Double-blind Controlled Trial

Resource links provided by NLM:


Further study details as provided by Medical Research Foundation, The Netherlands:

Primary Outcome Measures:
  • The effect of the breathing device on SBP is the main study parameter [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary endpoints include diastolic blood pressure (DBP) and quality of life. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: September 2009
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
Device: Resperate
device-guided breathing exercises
Sham Comparator: control device
Resperate device without slowing of breathing
Device: Resperate
breathing device without slowing of breathing frequency

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951119

Locations
Netherlands
Isala Clinics, Diabetes Centre
Zwolle, Netherlands, 8000 GM
Isala clinics
Zwolle, Netherlands, 8000 GM
Sponsors and Collaborators
Medical Research Foundation, The Netherlands
Investigators
Study Director: HEnk J.G. Bilo, MD, PhD, Professor, FRCP Diabetes centre, isala clinics
  More Information

No publications provided

Responsible Party: Nanne Kleefstra, Prof. dr. Bilo and N. Kleefstra, Medical Research Foundation, The Netherlands
ClinicalTrials.gov Identifier: NCT00951119     History of Changes
Other Study ID Numbers: Reperate3
Study First Received: August 3, 2009
Last Updated: October 23, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Medical Research Foundation, The Netherlands:
type 2 diabetes
hypertension
treatment
non-medical

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Hypertension
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 26, 2014