Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
05/MRE00/90
Study information
Scientific title
Very Early Rehabilitation or Intensive Telemetry After Stroke (VERITAS): a pilot randomised controlled trial
Acronym
VERITAS
Study hypothesis
Very early rehabilitation or intensive monitoring will reduce complications and improve patient recovery after stroke.
Ethics approval
Ethics Committee Scotland (A) MREC. Date of approval: 22/12/2005 (ref: 05/MRE00/90)
Study design
Single-blind, factorial (2 x 2) pilot randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Acute stroke
Intervention
The participants were randomly allocated to the following four arms:
1. Standard care: Early transfer to an established multidisciplinary stroke unit where they will receive conventional stroke unit care within an established stroke service
2. Early mobilisation plus standard care: The early mobilisation interventions are based on the AVERT trial (see below), and will begin within 24 hours of the onset of the symptoms. The protocol is functional and task specific and can be summarised as follows:
a. Mobilisation should commence as soon as possible on the stroke unit
b. Bedrest should be avoided if at all possible
c. Patients will be encouraged to be up, sitting and transferring at least 4 times per day
d. Any vulnerable hemioplegic shoulder will be cared for using supports when sitting, transferring and walking
The primary objective is to increase the frequency of mobilisation. The protocol will be delivered by the research nurse, under the supervision of a trained physiotherapist. During the first 3 days after stroke the stroke patients will be observed closely for abnormalities of heart rate, oxygen saturation and blood pressure during mobilisation. If there are any abnormalities during these procedures, mobilisation will be discontinued. The five stages for monitoring are as follows:
i. Before mobilisation (lying in bed)
ii. Sitting upright in bed
iii. Sitting on the edge of the bed
iv. After five minutes sitting on the edge of the bed
v. After transferring to a chair
The duration of each early mobilisation intervention will be determined by the patient tolerance but will range between 5 and 30 minutes per session. The research nurse trained in the intervention will be available on the ward during weekdays as will be supervising physiotherapist. The intervention will continue for at least 7 days or until discharge whichever is sooner.
3. Automated physiological monitoring: Standard care plus a protocol based on the Gateshead trial (see below) guiding the continuous monitoring. This will use an established commercial system (Welch Allyn Inc), which will include the possibility of ambulatory monitoring. The protocol will include advice on responding to abnormalities of heart rate or rhythm, blood pressure, temperature, oxygen level or blood glucose. Routine monitoring will be continued for the first three days and extended beyond then if persisting abnormalities are identified. After this time patients will revert to standard care. The research nurse will devote time to ensuring the monitoring protocol is followed.
4. A combined protocol incorporating both 2 and 3 above
Total duration of interventions: 1 week
Total duration of follow-up: 3 months
Information on the AVERT trial can be found at http://www.ncbi.nlm.nih.gov/pubmed/18706042
Information on the Gateshead trial can be found in the 1998 British Geriatrics Society autumn meeting abstract (http://www.ncbi.nlm.nih.gov/pubmed/10450456) - Davis M, Hollyman C, McGiven M, Chambers I, Egbuji J, Barer D. Physiological monitoring in acute stroke. Age Ageing 1999 (Suppl):P33
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The following will be monitored for 7 days:
1. Feasibility (especially treatment contamination)
2. Acceptability of the trial process
3. Safety of the trial process: early complications and adverse events
Note: The primary outcome of the proposed main trial will be the proportion of patients dead or disabled (Modified Rankins Score 3-5) at 3 months post stroke.
Secondary outcome measures
Patient activity, recorded for 7 days using automated activity monitors which record the time spent lying, sitting, standing or walking.
Overall trial start date
01/03/2007
Overall trial end date
01/02/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Individuals (both males and females) admitted to hospital with symptoms of new stroke within 24 hours of symptom onset (with the primary objective of recruiting individuals within 12 hours of symptom onset).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant exclusion criteria
1. Individuals with severe pre-stroke disability
2. Those who have made a full recovery
3. Severe comorbidities which would prevent their participation in the trial
Recruitment start date
01/03/2007
Recruitment end date
01/02/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Section of Geriatric Medicine
Glasgow
G31 2ER
United Kingdom
Sponsor information
Organisation
Greater Glasgow and Clyde NHS Board (UK)
Sponsor details
East Research Office
Glasgow Royal Infirmary
4th Floor Walton Building
84 Castle Street
Glasgow
G4 0SF
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Chest, Heart and Stroke Scotland (Ref: 05/A87)
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
Basic results (scientific)
Publication list
1. 2010 results of pilot study in http://www.ncbi.nlm.nih.gov/pubmed/20130401
Publication citations
-
Results
Langhorne P, Stott D, Knight A, Bernhardt J, Barer D, Watkins C, Very early rehabilitation or intensive telemetry after stroke: a pilot randomised trial., Cerebrovasc. Dis., 2010, 29, 4, 352-360, doi: 10.1159/000278931.