Stroke Unit effect on Physical Activity
| ISRCTN | ISRCTN13447832 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13447832 |
| IRAS number | 294935 |
| Secondary identifying numbers | IRAS 294935 |
- Submission date
- 16/03/2021
- Registration date
- 01/06/2021
- Last edited
- 01/07/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
The most common cause of disability from stroke is motor impairment affecting around 80% of stroke survivors with up to 74% needing long-term support with basic daily activities. Patients spend more than 78% of their inpatient stay alone, inactive and sedentary. An increase in physical activity and the provision of self-directed therapy programmes are recommended to improve recovery.
Enriched environments are designed to allow patients to move around freely around the ward to access activities. They have been shown to increase physical activity and reduce the amount of time patients spend alone. Enriched environments also have the potential to support self-directed therapy practice.
A recent opportunity arose to design a new purpose-built stroke unit in Gateshead which will incorporate aspects of an enriched environment. Patients who are able and well enough, will be encouraged to spend the majority of their waking hours in a communal ‘social’ area and therapy garden. This will provide enhanced opportunities for mobility practice and semi-supervised therapy practice. It is anticipated that this will start to facilitate changes in the ward routines that more closely mirror routines at home. For example, patients getting up and dressed for breakfast at a table rather than having breakfast in bed.
This study aims to assess the impact of an enriched environment on physical activity and other outcomes in stroke rehabilitation patients.
Who can participate?
Consenting adult stroke patients who have been admitted to the stroke ward at the Queen Elizabeth Hospital in Gateshead in the previous 72 h
What does the study involve?
Patients will complete baseline assessments and asked to wear an accelerometer on their wrist to measure their physical activity levels for 3-7 days. Comparisons of daily activity levels will be made between patients treated on the old stroke ward and those on the new stroke unit. Further comparisons will be made between the two patient groups of functional independence and stroke impact will be made at the time of hospital discharge and 6 weeks after joining the study.
What are the possible benefits and risks of participating?
This is an evaluation of a new purpose-built stroke unit and its effect on physical activity. As such participants will be asked to provide data on outcomes and to have their physical activity levels monitored but will receive the same treatment as other patients on the ward. As such there will be no direct benefits or risks for those taking part in the study.
The safety of the new environment will be evaluated by examining the occurrence of all serious adverse events (SAEs) as well as all falls. Recording of any serious adverse events and falls will occur for the duration of a participant’s involvement in the study at study assessments by asking participants the question the following question: “have there been any new medical problems since the last study assessment?”. All SAEs will be reported to the Chief Investigator and trial sponsor within 24 hours. The main REC will be notified of related and unexpected SAEs within 15 days of the Chief Investigator becoming aware of the event.
Where is the study run from?
Queen Elizabeth Hospital (UK)
When is the study starting and how long is it expected to run for?
From November 2020 to December 2021
Who is funding the study?
The is being conducted as an evaluation of the newly designed stroke unit at Gateshead Health NHS Foundation Trust (UK) an no external funding has been incurred.
Who is the main contact?
Dr Ruth Da Silva, ruth.dasilva@nhs.net
Contact information
Scientific
Queen Elizabeth Hospital
Queen Elizabeth Avenue
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom
 ORCID ID |
0000-0002-8897-4090 |
|---|---|
| Phone | +44 (0)191 4453903 |
| ruth.dasilva@nhs.net |
Study information
| Study design | Single-centre prospective cohort observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Stroke Unit Effect on the Physical Activity Levels of patients on a non-hyperacute stroke unit |
| Study acronym | SUPAL |
| Study objectives | To measure whether exposure to a purpose-built stroke unit is associated with changes in physical activity and other parameters in stroke rehabilitation patients. |
| Ethics approval(s) | Approved 12/03/2021, West of Scotland Research Ethics Service 3 (Clinical Research and Development, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE; +44 (0)141 314 0211; WoSREC3@ggc.scot.nhs.uk ), ref: 21/WS/0030 |
| Health condition(s) or problem(s) studied | Stroke |
| Intervention | The activity levels of stroke patients treated on a new purpose-built stroke unit (designed as an 'enriched environment' to reduce sedentary behaviours and promote mobility) will be compared to those treated on the current acute medical ward. The study will take place before and after the advent of exposure to a new purpose-built unit. Patients who are able to provide informed consent will be approached to take part in the study within 72 h of arriving on the ward. A member of the study team will provide them with a patient information sheet, discuss the study with them and offer them the opportunity to ask any questions before making a decision. Once consented, baseline assessment will be carried out and patients will be provided with a wristband accelerometer programmed to start recording activity from midnight. This is to ensure that when analysing the accelerometer data complete days rather than partial days of data are available for comparison. Participants will wear the accelerometers for up to 7 days (a minimum of 3 days data is required for data to be included). There will be no change to the care that participants receive during their stay on the ward. The pre-change participants will receive usual care in the existing acute medical ward. The post-change participants will receive usual care in a new purpose-built stroke unit. Once a discharge date has been set, participants will be asked to complete the discharge assessment which should take approximately 30 min. In the event that a member of the study team is unavailable to complete the assessment before discharge, this will be carried out over the telephone within 2 days of discharge. A follow-up assessment will be carried out at 6 weeks after consent which will be carried out by a stroke nurse. |
| Intervention type | Not Specified |
| Primary outcome measure | Physical activity measured using wrist-worn accelerometers between baseline and 3 to 7 days |
| Secondary outcome measures | 1. Level of dependency measured using the modified Rankin Scale at discharge and 6 weeks 2. Ability to perform activities of daily living measured using the Barthel Index at discharge and 6 weeks 3. Quality of life and participation measured using the Stroke Impact Scale at discharge and 6 weeks |
| Overall study start date | 18/11/2020 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 40 |
| Key inclusion criteria | 1. Aged >18 years 2. Within 72 h of admission to the stroke ward 3. Patient able to provide informed consent to participate in the study 4. Living within the local community services catchment area |
| Key exclusion criteria | 1. Diagnosis which is likely to interfere with rehabilitation e.g. issues with infection control 2. Palliative treatment approach being provided |
| Date of first enrolment | 17/03/2021 |
| Date of final enrolment | 17/03/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom
Sponsor information
Hospital/treatment centre
Queen Elizabeth Avenue
Sheriff Hill
Gateshead
NE9 6SX
England
United Kingdom
| Phone | +44 (0)191 4452155 |
|---|---|
| alison.harvey5@nhs.net | |
| Website | https://www.qegateshead.nhs.uk/ |
"ROR" |
https://ror.org/01aye5y64 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned participation in peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request by email to Ruth Da Silva, ruth.dasilva@nhs.net. Only summary statistics will be made available (for the purpose of publishing results) of patient characteristics; study outcome measures (Fatigue, Barthel Index, modified Rankin Scale, stroke impact scale and falls frequency). Individual participants’ data will not be made available. All data will be anonymised. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
01/07/2021: Internal review.
17/03/2021: Trial’s existence confirmed by West of Scotland Research Ethics Service 3.
