Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MS2
Study information
Scientific title
Assessing the efficacy of exercising with the RESPeRATE device to lower blood pressure in diabetic hypertensives: a randomised controlled trial
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
Home
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 measure
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 (if study stopped)
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
Both
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
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
Basic results (scientific)
Publication list
1. Presentation of results at the European Society of Hypertension meeting in Milan, Italy (no web links found):
1.a 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
1.b 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
2. 2009 results in https://www.ncbi.nlm.nih.gov/pubmed/19005477