Covid19NCT04618835
Physical Activity a Vital Sign? 40 Steps to Safety Test for Patients With COVID-19
An observational study of Covid19 and Medical Emergencies, run by Betsi Cadwaladr University Health Board at 1 site in United Kingdom.
Trial summary
Exertional desaturation is a feature of COVID-19. The study will measure vital signs of patients discharge by practitioners in primary care, secondary care or by paramedic practitioners. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Medical Emergencies
- What is being tested?
- 40-Steps-test
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Jan 2021to 3 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All alert and mobile acutely ill patients with mild symptoms and little or no vital sign derangement being considered for discharge to independent care
Who may be able to join
- Patients are being considered for discharge to independent care
- Participant is willing and able to give informed consent for participation in the study.
- Patient with independent, stable, gait
- Patient is alert, attentive, coherent, and calm
- Male or Female, aged 18 years or above.
Who cannot join
- Minor injuries
- Elective surgery patients
- Post-operative patients at discharge
- Requires supplemental oxygen
- Shortness of breath at rest (i.e. Borg or Numerical Rating Scale >=2)
- Unstable angina
Show all 14Show fewer
- Patients on long-term-oxygen therapy
- Pregnancy as stated by patient
- Oxygen saturations < 95% on room air
- Resting heart rate > 100 bpm
- Resting respiratory rate > 25 bpm
- ECG with signs of acute ischemia in patients where an ECG has been requested by the treating clinician
- National Early Warning Score of 5 or more
- Nursing home residents, or those being transferred to a nursing home or similar care facility
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Ysbyty Gwynedd
Menai Bridge, Gwynedd, LL57 2PW
Christian Subbe, 07771922890, csubbe@hotmail.com
Laura Langshaw, +441248384384, laura.longshaw@wales.nhs.uk
About this study
Official title: Exertional Desaturation as a Marker of Risk - Validation Study for the 40-steps-test; A Multi-centre Prospective Observational Cohort Study
Exertional desaturation is a feature of COVID-19. The study will measure vital signs of patients discharge by practitioners in primary care, secondary care or by paramedic practitioners. Patients will then undertake a 40-steps on the spot walk followed by measurements of heart rate and oxygen saturations for up to two minutes. Association of desaturation with 30 days hospital admission and mortality will be reported.
- Conditions
- Covid19, Medical Emergencies
- Being tested
- 40-Steps-test
- Keywords
- Exercise tolerance test, Vital signs, Readmission, Mortality
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
40-Steps-testDiagnostic test
40 steps performed on the spot
| Study group | Role | What they receive |
|---|---|---|
| Emergency presentations | Patients discharged after a presentation to practitioners in the community, primary and secondary care. Receives: Diagnostic Test: 40-Steps-test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in decision to discharge
- No change
- Further investigations
- Hospital admission
- No change b) Further investigations c) Hospital admission
Measured: 24 hours
Hospital
Admission to hospital within 30 days of the test
Measured: 30 days
Death
Death within 30 days of the test
Measured: 30 days
Secondary outcomes (5)
Feasibility of the 40-steps test
Proportion of sites and patients able to undertake the test
Measured: 12 months
Change in heart rate
Change in heart rate compared to value measured before expercise
Measured: Within 2 minutes of completion of the test
Change in oxygen saturations
Change in heart rate compared to value measured before exercise
Measured: Within 2 minutes of completion of the test
Change in respiratory rate
Change in respiratory rate compared to value measured before exercise
Measured: Within 2 minutes of completion of the test
Change in breathlessness
Change in breathlessness compared to value measured before exercise
Measured: Within 2 minutes of completion of the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start11 Jan 2021
- Primary completion3 Nov 2021 (estimated)
- Study completion3 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betsi Cadwaladr University Health Board
- Sponsor type
- Other government
- Collaborators
- Oxford Brookes University
- Responsible party
- Principal investigator, Dr Christian P Subbe, Betsi Cadwaladr University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618835
- Sponsor's protocol ID
- 283998
- Status last verified
- Feb 2021
- First submitted
- 31 Oct 2020
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exertional Desaturation as a Marker of Risk - Validation Study for the 40-steps-test; A Multi-centre Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT04618835
- Acronym / sponsor ID
- 283998
- Conditions
- Covid19, Medical Emergencies
- Keywords
- Exercise tolerance test, Vital signs, Readmission, Mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Betsi Cadwaladr University Health BoardOther government
- Collaborators
- Oxford Brookes University
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 3 Nov 2021 (estimated)
- Study completion
- 3 Nov 2021 (estimated)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Exertional desaturation is a feature of COVID-19. The study will measure vital signs of patients discharge by practitioners in primary care, secondary care or by paramedic practitioners. Patients will then undertake a 40-steps on the spot walk followed by measurements of heart rate and oxygen saturations for up to two minutes. Association of desaturation with 30 days hospital admission and mortality will be reported.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency presentations | – | Diagnostic Test: 40-Steps-testPatients discharged after a presentation to practitioners in the community, primary and secondary care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All alert and mobile acutely ill patients with mild symptoms and little or no vital sign derangement being considered for discharge to independent care
Key inclusion criteria (5 listed)
- Patients are being considered for discharge to independent care
- Participant is willing and able to give informed consent for participation in the study.
- Patient with independent, stable, gait
- Patient is alert, attentive, coherent, and calm
- Male or Female, aged 18 years or above.
Key exclusion criteria (14 listed)
- Minor injuries
- Elective surgery patients
- Post-operative patients at discharge
- Requires supplemental oxygen
- Shortness of breath at rest (i.e. Borg or Numerical Rating Scale >=2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 40-Steps-test40 steps performed on the spot | Diagnostic test | Emergency presentations |
Primary outcome
Change in decision to discharge
Time frame: 24 hours
1. No change 2. Further investigations 3. Hospital admission a) No change b) Further investigations c) Hospital admission
Hospital
Time frame: 30 days
Admission to hospital within 30 days of the test
Death
Time frame: 30 days
Death within 30 days of the test
5 secondary outcomes
Feasibility of the 40-steps test
Time frame: 12 months
Change in heart rate
Time frame: Within 2 minutes of completion of the test
Change in oxygen saturations
Time frame: Within 2 minutes of completion of the test
Change in respiratory rate
Time frame: Within 2 minutes of completion of the test
Change in breathlessness
Time frame: Within 2 minutes of completion of the test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Medical Emergencies, run by Betsi Cadwaladr University Health Board at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Subbe, DM (+447771922890, csubbe@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in decision to discharge (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.