Exercise training early after stroke: a feasibility study
| ISRCTN | ISRCTN74167784 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74167784 |
| Protocol serial number | AP0875 |
| Sponsor | Action Medical Research (UK) |
| Funder | Action Medical Research (UK) |
- 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
Scientific
Clinical Practice Research Unit
Department of Nursing
University of Central Lancashire
Preston
PR1 2HE
United Kingdom
| Phone | +44 (0) 1772 893647 |
|---|---|
| mjleathley@uclan.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Arm and leg function: the Motor Assessment Scale |
| Key secondary outcome measure(s) |
1. Functional dependence: the Barthel Index |
| Completion date | 30/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Clinical Practice Research Unit
Preston
PR1 2HE
United Kingdom
PR1 2HE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
