Evaluation of the sustained effect of Viniyoga in the rehabilitation of hypertensive patients
| ISRCTN | ISRCTN27834915 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27834915 |
| Protocol serial number | 1 |
| Sponsor | Refonet (Germany) |
| Funder | Refonet (Germany) |
- Submission date
- 06/06/2007
- Registration date
- 05/11/2007
- Last edited
- 05/11/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Claudia Fusshoeller
Scientific
Scientific
Klinik Roderbirken
Leichlingen
D-42799
Germany
| Phone | +49 (0)2175 824310 |
|---|---|
| Claudia.Fusshoeller@klinik-roderbirken.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | We hypothesise that patients who receive training in Viniyoga will continue practising the method 15% more often than those who receive training in Progressive Relaxation. |
| Ethics approval(s) | Ethics approval received from the Ethics Committee of Arztekammer Nordrhein in May 2007 (ref: 2007113). |
| Health condition(s) or problem(s) studied | Arterial hypertension |
| Intervention | Viniyoga or Progressive Relaxation group training (maximum 10 people per group), 45 minutes per session, five days a week for three weeks. |
| Intervention type | Other |
| Primary outcome measure(s) |
To assess whether more participants in the intervention group will maintain the method taught compared to those in the control group, assessed at three weeks (i.e. at the moment of discharge from our hospital) and six months after the discharge from the hospital. |
| Key secondary outcome measure(s) |
The following will be measured at six months: |
| Completion date | 06/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 300 |
| Key inclusion criteria | Arterial Hypertension. |
| Key exclusion criteria | 1. Congestive heart failure (New York Heart Association [NYHA] II or more) 2. Relevant rhythm disorders 3. Relevant pulmonary disease 4. Dialyses 5. Surgery within the last four weeks 6. ST-elevation myocardial infarction within the last four weeks |
| Date of first enrolment | 07/05/2007 |
| Date of final enrolment | 06/05/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Klinik Roderbirken
Leichlingen
D-42799
Germany
D-42799
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
