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

• Conditions: Covid19; Medical Emergencies
• Interventions: Diagnostic Test: 40-Steps-test

• Registration Number: NCT04618835
• Lead Sponsor: Betsi Cadwaladr University Health Board

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-31
• Study First Submitted QC: 2020-11-05
• Study First Posted: 2020-11-06
• Study Start: 2021-01-11
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-24
• Primary Completion: 2021-11-03
• Study Completion: 2021-11-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Emergency presentations	40-Steps-test	Patients discharged after a presentation to practitioners in the community, primary and secondary care.

Primary Outcome Measures

Name	Time	Method
Death	30 days	Death within 30 days of the test
Change in decision to discharge	24 hours	1. No change; 2. Further investigations; 3. Hospital admission; a) No change b) Further investigations c) Hospital admission
Hospital	30 days	Admission to hospital within 30 days of the test

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ysbyty Gwynedd; 🇬🇧 Menai Bridge, Gwynedd, United Kingdom