Condition category
Nutritional, Metabolic, Endocrine
Date applied
23/05/2007
Date assigned
10/07/2007
Last edited
10/07/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Moshe Schein

ORCID ID

Contact details

Hadassah Hospital
Family Medicine Unit
Jerusalem
91120
Israel

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MS2

Study information

Scientific title

Acronym

Study hypothesis

Exercising with the RESPeRATE device, if done appropriately at home for eight weeks, can reduce high Blood Pressure (BP) safely and efficaciously in diabetic hypertensives.

Ethics approval

Approval received from the Hadassah Hospital Jerusalem Ethics Committee on the 11th June 2004.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Diabetes, hypertension

Intervention

The intervention is a 15-minute daily session of slow breathing exercise guided by the RESPeRATE device (http://www.resperate.com). The device monitors the user's breathing rate and pattern using a breathing sensor and composes music in real time to match the user's breathing inhalations and exhalations. The user then follows these tones that become longer and longer, so that gradually the breathing rate decreases and expiration becomes longer.

The treatment lasted for eight weeks. There were two visits for baseline, one for follow up after four weeks and one for termination after eight weeks. The control group continued with their usual care and had the same office visits and tests.

Intervention type

Device

Phase

Not Specified

Drug names

Primary outcome measures

Blood pressure: during each visit BP was measured.

Secondary outcome measures

Secondary outcomes are the validated QSD "Questionnaire of Stress in Diabetics", diastolic BP, fasting glucose, HbA1C and fructosamine.

Questionnaire and blood tests for glucose, HbA1C and fructosamine were taken at baseline and end of follow-up.

Overall trial start date

01/09/2004

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Non-insulin dependent diabetes mellitus
2. Average BP level, as measured in visits one and two: Systolic Blood Pressure (SBP) above 130 mmHg, and difference in BP levels between the two visits was not greater than 5 mmHg for SBP and 2 mmHg for Diastolic Blood Pressure (DBP)
3. Aged 40 to 79 years
4. No change in prescribed anti-hypertensive therapy, pharmacological or lifestyle modification for one month prior to visit one

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

70

Participant exclusion criteria

1. Taking insulin
2. Active ischaemic heart disease/unstable angina
3. Major stroke with major impairment
4. Pregnant woman
5. Obesity: body mass index greater than 40
6. Major psychiatric disorder
7. Unable to operate a portable tape
8. Blind or deaf
9. Participates in another study

Recruitment start date

01/09/2004

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Israel

Trial participating centre

Hadassah Hospital
Jerusalem
91120
Israel

Sponsor information

Organisation

InterCure (Israel)

Sponsor details

6 Habbal Shem Tov Street
Lod
71285
Israel

Sponsor type

Industry

Website

http://www.resperate.com

Funders

Funder type

Industry

Funder name

InterCure (Israel)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Presentation of results at the European Society of Hypertension meeting in Milan, Italy (no web links found):
1. High blood pressure reduction in diabetics with interactive device-guided paced breathing: final results of a randomized controlled study. Authors: Moshe H Schein, MD, Ariela Alter, PhD, Simon Levine, MD, Tuvia Baevsky, MD, Alona Nessing, MD, and Benjamin Gavish, PhD. European Society of Hypertension meeting in Milan, Italy
2. Reduction of stress by interactive device-guided paced breathing in diabetes with high blood pressure: a randomized controlled study. Authors: Moshe H Schein, MD, Ariela Alter, PhD, Simon Levine, MD, Tuvia Baevsky, MD, Alona Nessing, MD, and Benjamin Gavish, PhD. European Society of Hypertension meeting in Milan, Italy

Publication citations

Additional files

Editorial Notes