Home orthostatic training in vasovagal syncope (The HOT VVS-1 study): A placebo controlled trial

ISRCTN	ISRCTN17688061
DOI	https://doi.org/10.1186/ISRCTN17688061
Protocol serial number	N0503172648
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funder	Newcastle upon Tyne Hospitals NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr SW Parry
Scientific

Department of Medicine
Royal Victoria Infirmary
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Primary study design	Interventional
Study design	Randomised single-blind placebo controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	The HOT VVS-1 study
Study objectives	Added 19/11/09: To detect possible autonomic changes due to home orthostatic training (HOT) and to assess the feasibility of a larger, placebo-controlled study of HOT in vasovagal syncope (VVS).
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Vasovagal syncope
Intervention	Home orthostatic training versus sham training in vasovagal syncope
Intervention type	Other
Primary outcome measure(s)	Number of syncopal episodes in each patient group, which will assess the efficacy of orthostatic training.
Key secondary outcome measure(s)	1. Time to tilt-positivity 2. Time to first spontaneous syncope or pre-syncope (where this was the symptom at presentation) 3. Number of patients experiencing syncope or pre-syncope during follow-up 4. Frequency of symptoms In addition, autonomic function tests will assess the mechanism by which orthostatic training works and improve the understanding of the mechanism behind vasovagal syncope. The impact of orthostatic training will be assessed using quality of life measures.
Completion date	31/05/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	40
Key inclusion criteria	Consecutive patients aged 18+ diagnosed with head-up tilt positive vasovagal syncope.
Key exclusion criteria	1. Inability to give informed consent 2. Patients on drugs which can affect the autonomic nervous system which cannot be discontinued safely 3. Inability to stand for up to 40 minutes due to muscular or neurological disorders, cardiac transplantation or pregnancy
Date of first enrolment	01/06/2005
Date of final enrolment	31/05/2006

Department of Medicine

Newcastle Upon Tyne
NE1 4LP
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2010		Yes	No