Contact information
Type
Scientific
Primary contact
Mrs Claudia Fusshoeller
ORCID ID
Contact details
Klinik Roderbirken
Leichlingen
D-42799
Germany
+49 (0)2175 824310
Claudia.Fusshoeller@klinik-roderbirken.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Acronym
Study hypothesis
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
Ethics approval received from the Ethics Committee of Arztekammer Nordrhein in May 2007 (ref: 2007113).
Study design
Randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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.
Secondary outcome measures
The 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 trial start date
07/05/2007
Overall trial end date
06/05/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Arterial Hypertension.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant 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
Recruitment start date
07/05/2007
Recruitment end date
06/05/2009
Locations
Countries of recruitment
Germany
Trial participating centre
Klinik Roderbirken
Leichlingen
D-42799
Germany
Sponsor information
Organisation
Refonet (Germany)
Sponsor details
Burgweg 3
Bad Neuenahr-Ahrweiler
D-53474
Germany
Claudia.Fusshoeller@klinik-roderbirken.de
Sponsor type
Research organisation
Website
Funders
Funder type
Industry
Funder name
Refonet (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary