Condition category
Circulatory System
Date applied
06/06/2007
Date assigned
05/11/2007
Last edited
05/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://refonet.de

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

Publication citations

Additional files

Editorial Notes