Evaluation of the sustained effect of Viniyoga in the rehabilitation of hypertensive patients

ISRCTN ISRCTN27834915
DOI https://doi.org/10.1186/ISRCTN27834915
Secondary identifying numbers 1
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

Klinik Roderbirken
Leichlingen
D-42799
Germany

Phone +49 (0)2175 824310
Email Claudia.Fusshoeller@klinik-roderbirken.de

Study information

Study designRandomised controlled trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeQuality of life
Scientific title
Study objectivesWe 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) studiedArterial hypertension
InterventionViniyoga or Progressive Relaxation group training (maximum 10 people per group), 45 minutes per session, five days a week for three weeks.
Intervention typeOther
Primary outcome measureTo 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.
Secondary outcome measuresThe following will be measured at six months:
1. Hospital Anxiety and Depression Scale [HADS]
2. 36-item Short Form health survey (SF-36)
3. Heart rate variability
4. Blood pressure
5. Use of antihypertensive medication
Overall study start date07/05/2007
Completion date06/05/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants300
Key inclusion criteriaArterial Hypertension.
Key exclusion criteria1. 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 enrolment07/05/2007
Date of final enrolment06/05/2009

Locations

Countries of recruitment

  • Germany

Study participating centre

Klinik Roderbirken
Leichlingen
D-42799
Germany

Sponsor information

Refonet (Germany)
Research organisation

Burgweg 3
Bad Neuenahr-Ahrweiler
D-53474
Germany

Email Claudia.Fusshoeller@klinik-roderbirken.de
Website http://refonet.de
ROR logo "ROR" https://ror.org/04yeh2x21

Funders

Funder type

Industry

Refonet (Germany)

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