Contact information
Type
Scientific
Primary contact
Dr M J Leathley
ORCID ID
Contact details
Clinical Practice Research Unit
Department of Nursing
University of Central Lancashire
Preston
PR1 2HE
United Kingdom
+44 (0) 1772 893647
mjleathley@uclan.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
AP0875
Study information
Scientific title
Acronym
Study hypothesis
Hypothesis:
It is practical for all stroke patients to undertake early exercise training (ET), regardless of level of impairment.
Brief summary:
Patients meeting the inclusion criteria will be randomised into one of two groups, usual care or intervention (ET). In addition to usual care, patients in the ET group will be individually taught a series of basic exercise activities for the arms and legs which can be done lying, sitting or standing, depending upon which of these positions the patient can maintain and prefers. Patients will be encouraged to perform those activities which they can, for up to 30 minutes 3 times per week. Once patients are confident of the activities they will be given simple, quirky prompts to remind them what do do. Data will be collected at baseline and at 3 months post-stroke.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Stroke
Intervention
Patients meeting the inclusion criteria will be randomised into one of two groups, usual care or intervention. The patients in the intervention group, will, in addition to their usual therapy, be taught a series of basic exercise activities for the arms and legs. Patients will be encouraged to perform the exercises for up to 30 minutes, three times per week.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Arm and leg function: the Motor Assessment Scale
Secondary outcome measures
1. Functional dependence: the Barthel Index
2. Psychological well-being: the GHQ 12 questionnaire
3. Tone: the modified Ashworth Scale
4. Power: the Medical Research Council Scale
5. Hand posture: the Tod Scale
6. A qualitative assessment of attitudes of patients, carers and staff to exercise training
Overall trial start date
01/09/2002
Overall trial end date
30/09/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Diagnosis of stroke
2. Surviving to week two
3. Still in hospital
4. Medically stable
5. Able to follow simple verbal instructions
6. 18 years of age and over, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Non-stroke
2. Died or care transferred into the community before week 2
3. Medically unstable
4. Unable to follow simple verbal instructions
5. Under 18 years of age
6. Non-consent
Recruitment start date
01/09/2002
Recruitment end date
30/09/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clinical Practice Research Unit
Preston
PR1 2HE
United Kingdom
Sponsor information
Organisation
Action Medical Research (UK)
Sponsor details
Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Action Medical Research (UK)
Alternative name(s)
AMR
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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
Results presented at a conference in July 2005. No publication intended as of 22/11/2011.