40 Steps to Safety: Can comparing blood oxygen levels before and after a person has walked 40 steps help to decide whether they can be safely discharged from hospital?
| ISRCTN | ISRCTN86554504 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86554504 |
| IRAS number | 283998 |
| Secondary identifying numbers | IRAS 283998 |
- Submission date
- 27/09/2020
- Registration date
- 31/08/2023
- Last edited
- 06/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Plain English Summary
Background and study aims
Patients with suspected infection with COVID-19 might appear well but their oxygen levels might dangerously drop on exertion. The National Health Service In England has suggested to ask patients to walk for 40 steps on the flat to assure oxygen levels stay stable before allowing patients with suspected COVID to return home. The 40-steps test has not been used for this purpose before. The aim of this study is to investigate the ability of this test to detect low blood oxygen levels in patients who appear well, to find out whether developing low oxygen levels with exercise can be used to identify patients who are at higher risk of becoming unwell in the future.
Who can participate?
Acutely unwell patients who attend hospitals or are assessed by paramedic crews
What does the study involve?
Participants are asked to undertake the 40 steps test. This will involve taking 40 steps on the spot at their normal walking speed. Researchers will check whether oxygen levels or heart rate change after the test. After 30 days researchers will follow up the participants.
What are the possible benefits and risks of participating?
Participants will be contributing to important research which could help develop a better way to identify patients who can be safely discharged from hospital. They will also be helping us to better understand the normal response to exercise, and how this is different in a range of medical conditions, including in COVID-19.
The researchers anticipate that taking part in this study is generally very safe. However, there is a small possibility of a fall, which could result in injury, whilst doing the 40-step test.
Some participants may experience symptoms such as breathlessness, light-headedness, or chest pain whilst taking part in the study.
Where is the study run from?
Betsi Cadwaladr University Health Board (UK)
When is the study starting and how long is it expected to run for?
September 2020 to May 2022
Who is funding the study?
Betsi Cadwaladr University Health Board (UK)
Who is the main contact?
Dr Christian P Subbe, christian.subbe@wales.nhs.uk
Contact information
Public
Ysbyty Gwynedd
Penrhosgarnedd
Bangor
LL57 2PW
United Kingdom
 ORCID ID |
0000-0002-3110-8888 |
|---|---|
| Phone | +44(0)1248 384384 |
| christian.subbe@wales.nhs.uk |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | 38814_PIS_V1.2_30Dec20.pdf |
| Scientific title | Exertional desaturation as a marker of risk – Validation study for the 40-steps-test: A multi-centre prospective observational cohort study |
| Study hypothesis | Absence of desaturation on performing the 40-steps-test is a predictor of safe discharge from hospital. |
| Ethics approval(s) | Approved 16/10/2020, Wales Research Ethics Committee 5 (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 (0)7970 422139; Wales.REC5@wales.nhs.uk), ref: 20/WA/0286 |
| Condition | All alert and mobile acutely ill patients considered for discharge to independent care including patients with suspected COVID-19 |
| Intervention | Performance of the 40-steps-test and measurement of oxygen saturations and pulse rate prior to the test and after completion. |
| Intervention type | Other |
| Primary outcome measure | Validation of the 40 steps on the spot test as a marker for safe discharge from hospital, assessed by collecting the following information from the participants’ medical records: 1. Change in decision to discharge following the 40 steps test 2. Outcome at 30 days following the test (30-day hospital admission and 30-day mortality) |
| Secondary outcome measures | Normal values for the 40 steps test challenge in a range of age groups: 1. Oxygen saturation measured by oximeter 2. Heart rate measured by oximeter 3. Breathlessness measured by number of breaths per minute and by using the rating scale for dyspnoea The above will be measured immediately after the 40 steps test and at 2 minutes after ending the test. Baseline values will be collected from medical records |
| Overall study start date | 18/09/2020 |
| Overall study end date | 01/05/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1000 |
| Participant inclusion criteria | 1. Patients who are being considered for discharge to independent care 2. Willing and able to give informed consent for participation in the study 3. Independent, stable gait 4. Alert, attentive, coherent and calm |
| Participant exclusion criteria | 1. Minor injuries 2. Elective surgery patients 3. Post-operative patients at discharge 4. Requires supplemental oxygen 5. Shortness of breath at rest (i.e. Borg or Numerical Rating Scale >=2) 6. Unstable angina 7. On long-term-oxygen therapy 8. Pregnancy as stated by patient 9. Oxygen saturation <95% on room air 10. Resting heart rate >100 bpm 11. Resting respiratory rate >25 bpm 12. ECG with signs of acute ischemia in patients where an ECG has been requested by the treating clinician 13. National Early Warning Score of 5 or more 14. Nursing home residents, or those being transferred to a nursing home or similar care facility |
| Recruitment start date | 30/11/2020 |
| Recruitment end date | 26/10/2021 |
Locations
Countries of recruitment
- Denmark
- Netherlands
- United Kingdom
- Wales
Study participating centre
Bangor
LL57 2PW
United Kingdom
Sponsor information
Hospital/treatment centre
Penrhosgarnedd
Bangor
LL57 2PW
Wales
United Kingdom
| Phone | +44-(1)-248-384-384 |
|---|---|
| BCU.researchapplications@wales.nhs.uk | |
| Website | https://bcuhb.nhs.wales/hospitals/ysbyty-gwynedd/ |
"ROR" |
https://ror.org/03awsb125 |
Funders
Funder type
Hospital/treatment centre
Government organisation / Local government
- Alternative name(s)
- Betsi Cadwaladr University Local Health Board, Bwrdd Iechyd Prifysgol Betsi Cadwaladr, Health Board, Betsi Cadwaladr UHB, Betsi Cadwaladr Local Health Board, BCUHB
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/01/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Results will be published in peer-reviewed journals on completion of the trial. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.2 | 30/12/2020 | 27/07/2023 | No | Yes |
| Results article | 20/04/2022 | 06/09/2023 | Yes | No |
Additional files
Editorial Notes
06/09/2023: Publication reference added.
27/07/2023: Study's existence confirmed by the HRA.
