Assessing the efficacy of exercising with the RESPeRATE device to lower blood pressure in diabetic hypertensives

ISRCTN ISRCTN00985733
DOI https://doi.org/10.1186/ISRCTN00985733
Secondary identifying numbers MS2
Submission date
23/05/2007
Registration date
10/07/2007
Last edited
02/10/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Moshe Schein
Scientific

Hadassah Hospital
Family Medicine Unit
Jerusalem
91120
Israel

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Home
Study typeTreatment
Scientific titleAssessing the efficacy of exercising with the RESPeRATE device to lower blood pressure in diabetic hypertensives: a randomised controlled trial
Study objectivesExercising 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(s)Approval received from the Hadassah Hospital Jerusalem Ethics Committee on the 11th June 2004.
Health condition(s) or problem(s) studiedDiabetes, hypertension
InterventionThe 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 typeDevice
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)
Primary outcome measureBlood pressure: during each visit BP was measured.
Secondary outcome measuresSecondary 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 study start date01/09/2004
Completion date31/12/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants70
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/09/2004
Date of final enrolment31/12/2006

Locations

Countries of recruitment

  • Israel

Study participating centre

Hadassah Hospital
Jerusalem
91120
Israel

Sponsor information

InterCure (Israel)
Industry

6 Habbal Shem Tov Street
Lod
71285
Israel

Website http://www.resperate.com

Funders

Funder type

Industry

InterCure (Israel)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/05/2009 Yes No

Editorial Notes

02/10/2017: Publication reference added.