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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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30 October 2017 |
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Main ID: |
ISRCTN00985733 |
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Date of registration:
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10/07/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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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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Assessing the efficacy of exercising with the RESPeRATE device to lower blood pressure in diabetic hypertensives: a randomised controlled trial |
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Date of first enrolment:
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01/09/2004 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN00985733 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Not Specified
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Countries of recruitment
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Israel
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Moshe
Schein |
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Address:
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Hadassah Hospital
Family Medicine Unit
91120
Jerusalem
Israel |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Diabetes, hypertension
Nutritional, Metabolic, Endocrine
Diabetes
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Intervention(s)
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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(s)
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Blood pressure: during each visit BP was measured.
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Secondary Outcome(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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Source(s) of Monetary Support
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InterCure (Israel)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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