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
Scientific
Hadassah Hospital
Family Medicine Unit
Jerusalem
91120
Israel
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home |
| Study type | Treatment |
| Scientific title | Assessing the efficacy of exercising with the RESPeRATE device to lower blood pressure in diabetic hypertensives: a randomised controlled trial |
| Study objectives | 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(s) | Approval received from the Hadassah Hospital Jerusalem Ethics Committee on the 11th June 2004. |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | |
| 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 study start date | 01/09/2004 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 70 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2004 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Israel
Study participating centre
Hadassah Hospital
Jerusalem
91120
Israel
91120
Israel
Sponsor information
InterCure (Israel)
Industry
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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.
