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12 February 2012
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| [ ...Back to search results ] | [ Print-friendly version ] |
| Very Early Rehabilitation or Intensive Telemetry After Stroke (VERITAS) |
| ISRCTN | ISRCTN23817752 |
| ClinicalTrials.gov identifier | |
| Public title | Very Early Rehabilitation or Intensive Telemetry After Stroke (VERITAS) |
| Scientific title | Very Early Rehabilitation or Intensive Telemetry After Stroke (VERITAS): a pilot randomised controlled trial |
| Acronym | VERITAS |
| Serial number at source | 05/MRE00/90 |
| Study hypothesis | Very early rehabilitation or intensive monitoring will reduce complications and improve patient recovery after stroke. |
| Lay summary | |
| 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 |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Acute stroke |
| Participants - 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). |
| Participants - 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 |
| Anticipated start date | 01/03/2007 |
| Anticipated end date | 01/02/2008 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 20 |
| Interventions |
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 |
| Primary outcome measure(s) |
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 measure(s) | Patient activity, recorded for 7 days using automated activity monitors which record the time spent lying, sitting, standing or walking. |
| Sources of funding | Chest, Heart and Stroke Scotland (Ref: 05/A87) |
| Trial website | |
| Publications | |
| Contact name | Prof Peter Langhorne |
| Address |
Academic Section of Geriatric Medicine
Level 3, University Block Royal Infirmary |
| City/town | Glasgow |
| Zip/Postcode | G31 2ER |
| Country | United Kingdom |
| Sponsor | Greater Glasgow and Clyde NHS Board (UK) |
| Address |
East Research Office
Glasgow Royal Infirmary 4th Floor Walton Building 84 Castle Street |
| City/town | Glasgow |
| Zip/Postcode | G4 0SF |
| Country | United Kingdom |
| Sponsor website: | http://www.nhsggc.org.uk |
| Date applied | 27/08/2008 |
| Last edited | 30/09/2008 |
| Date ISRCTN assigned | 30/09/2008 |
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