Physical Activity a Vital Sign? 40 Steps to Safety Test for Patients With COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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Exertional Desaturation as a Marker of Risk - Validation Study for the 40-steps-test; A Multi-centre Prospective Observational Cohort Study

Conditions
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Covid19, Medical Emergencies

Intervention / Treatment
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* Diagnostic Test: 40-Steps-test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Emergency presentations<br>Patients discharged after a presentation to practitioners in the community, primary and secondary care. | Diagnostic Test: 40-Steps-test<br>* 40 steps performed on the spot<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in decision to discharge | No change Further investigations Hospital admission a) No change b) Further investigations c) Hospital admission | 24 hours | 
| Hospital | Admission to hospital within 30 days of the test | 30 days | 
| Death | Death within 30 days of the test | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the 40-steps test | Proportion of sites and patients able to undertake the test | 12 months | 
| Change in heart rate | Change in heart rate compared to value measured before expercise | Within 2 minutes of completion of the test | 
| Change in oxygen saturations | Change in heart rate compared to value measured before exercise | Within 2 minutes of completion of the test | 
| Change in respiratory rate | Change in respiratory rate compared to value measured before exercise | Within 2 minutes of completion of the test | 
| Change in breathlessness | Change in breathlessness compared to value measured before exercise | Within 2 minutes of completion of the test | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise tolerance test, Vital signs, Readmission, Mortality