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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04618835
Enrollment
1000
Registered
2020-11-06
Start date
2021-01-11
Completion date
2021-11-03
Last updated
2021-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19, Medical Emergencies

Keywords

Exercise tolerance test, Vital signs, Readmission, Mortality

Brief 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. 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.

Interventions

DIAGNOSTIC_TEST40-Steps-test

40 steps performed on the spot

Sponsors

Oxford Brookes University
CollaboratorOTHER
Betsi Cadwaladr University Health Board
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in decision to discharge24 hours1. No change 2. Further investigations 3. Hospital admission a) No change b) Further investigations c) Hospital admission
Hospital30 daysAdmission to hospital within 30 days of the test
Death30 daysDeath within 30 days of the test

Secondary

MeasureTime frameDescription
Change in respiratory rateWithin 2 minutes of completion of the testChange in respiratory rate compared to value measured before exercise
Feasibility of the 40-steps test12 monthsProportion of sites and patients able to undertake the test
Change in breathlessnessWithin 2 minutes of completion of the testChange in breathlessness compared to value measured before exercise
Change in heart rateWithin 2 minutes of completion of the testChange in heart rate compared to value measured before expercise
Change in oxygen saturationsWithin 2 minutes of completion of the testChange in heart rate compared to value measured before exercise

Countries

United Kingdom

Contacts

Primary ContactChristian Subbe, DM
csubbe@hotmail.com+447771922890
Backup ContactLaura Langshaw
laura.longshaw@wales.nhs.uk+441248384384

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026