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ISRCTN
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ISRCTN00985733
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ClinicalTrials.gov identifier
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Public title
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Assessing the efficacy of exercising with the RESPeRATE device to lower blood pressure in diabetic hypertensives
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Scientific title
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Acronym
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N/A
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Serial number at source
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MS2
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Approval received from the Hadassah Hospital Jerusalem Ethics Committee on the 11th June 2004.
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Study design
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Randomised controlled trial
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Countries of recruitment
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Israel
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Disease/condition/study domain
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Diabetes, hypertension
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/09/2004
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Anticipated end date
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31/12/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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70
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Interventions
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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.
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Primary outcome measure(s)
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Blood pressure: during each visit BP was measured.
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Secondary outcome measure(s)
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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.
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Sources of funding
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InterCure (Israel)
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Trial website
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Publications
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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
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Contact name
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Dr
Moshe
Schein
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Address
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Hadassah Hospital
Family Medicine Unit
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City/town
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Jerusalem
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Zip/Postcode
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91120
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Country
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Israel
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Sponsor
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InterCure (Israel)
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Address
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6 Habbal Shem Tov Street
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City/town
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Lod
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Zip/Postcode
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71285
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Country
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Israel
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Sponsor website:
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http://www.resperate.com
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Date applied
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23/05/2007
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Last edited
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10/07/2007
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Date ISRCTN assigned
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10/07/2007
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