Condition category
Circulatory System
Date applied
30/04/2003
Date assigned
30/04/2003
Last edited
22/11/2011
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

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 measures

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

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

http://www.action.org.uk/

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

Results - basic reporting

Publication summary

Results presented at a conference in July 2005. No publication intended as of 22/11/2011.

Publication citations

Additional files

Editorial Notes