Condition category
Circulatory System
Date applied
27/08/2008
Date assigned
30/09/2008
Last edited
27/03/2012
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

Prof Peter Langhorne

ORCID ID

Contact details

Academic Section of Geriatric Medicine
Level 3
University Block
Royal Infirmary
Glasgow
G31 2ER
United Kingdom

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

Not Specified

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 measures

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

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

Not Specified

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

http://www.nhsggc.org.uk

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

Results - basic reporting

Publication summary

1. 2010 pilot study in http://www.ncbi.nlm.nih.gov/pubmed/20130401

Publication citations

  1. Pilot study

    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.

Additional files

Editorial Notes