Exercise training early after stroke: a feasibility study

ISRCTN	ISRCTN74167784
DOI	https://doi.org/10.1186/ISRCTN74167784
Secondary identifying numbers	AP0875

Submission date: 30/04/2003
Registration date: 30/04/2003
Last edited: 22/11/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M J Leathley
Scientific

Clinical Practice Research Unit
Department of Nursing
University of Central Lancashire
Preston
PR1 2HE
United Kingdom

Phone	+44 (0) 1772 893647
Email	mjleathley@uclan.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
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 study start date	01/09/2002
Completion date	30/09/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	60
Key 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
Key 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
Date of first enrolment	01/09/2002
Date of final enrolment	30/09/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Clinical Practice Research Unit

Preston
PR1 2HE
United Kingdom

Sponsor information

Action Medical Research (UK)
Charity

Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom

Website	http://www.action.org.uk/
"ROR"	https://ror.org/01wcqa315

Funders

Funder type

Charity

Action Medical Research (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): actionmedres, action medical research for children, AMR
Location: United Kingdom

Results and Publications

Intention to publish date
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