Home orthostatic training in vasovagal syncope (The HOT VVS-1 study): A placebo controlled trial
ISRCTN | ISRCTN17688061 |
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DOI | https://doi.org/10.1186/ISRCTN17688061 |
Secondary identifying numbers | N0503172648 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 25/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr SW Parry
Scientific
Scientific
Department of Medicine
Royal Victoria Infirmary
Newcastle Upon Tyne
NE1 4LP
United Kingdom
Study information
Study design | Randomised single-blind placebo controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 | Number of syncopal episodes in each patient group, which will assess the efficacy of orthostatic training. |
Secondary outcome measures | 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. |
Overall study start date | 01/06/2005 |
Completion date | 31/05/2006 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 40 (20 in each arm of the study) |
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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Medicine
Newcastle Upon Tyne
NE1 4LP
United Kingdom
NE1 4LP
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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dhmail@doh.gsi.org.uk | |
Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Newcastle upon Tyne Hospitals NHS Trust (UK)
Government organisation / Local government
Government organisation / Local government
- Alternative name(s)
- Newcastle upon Tyne Hospitals NHS Trust
- Location
- United Kingdom
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/02/2010 | Yes | No |