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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04618835
• Other study ID #: 283998
• Status: Recruiting
• Start date: January 11, 2021
• Est. completion date: November 3, 2021

Study information

• Verified date: February 2021
• Source: Betsi Cadwaladr University Health Board
• Contact: Christian Subbe, DM
• Phone: +447771922890
• Email: csubbe[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: November 3, 2021
• Est. primary completion date: November 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Emergencies
• Medical Emergencies

Intervention

Diagnostic Test:
• 40-Steps-test
40 steps performed on the spot

Locations

Country	Name	City	State
United Kingdom	Ysbyty Gwynedd	Menai Bridge	Gwynedd

Sponsors (2)

Lead Sponsor	Collaborator
Betsi Cadwaladr University Health Board	Oxford Brookes University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in decision to discharge	No change; Further investigations; Hospital admission; a) No change b) Further investigations c) Hospital admission	24 hours
Primary	Hospital	Admission to hospital within 30 days of the test	30 days
Primary	Death	Death within 30 days of the test	30 days
Secondary	Feasibility of the 40-steps test	Proportion of sites and patients able to undertake the test	12 months
Secondary	Change in heart rate	Change in heart rate compared to value measured before expercise	Within 2 minutes of completion of the test
Secondary	Change in oxygen saturations	Change in heart rate compared to value measured before exercise	Within 2 minutes of completion of the test
Secondary	Change in respiratory rate	Change in respiratory rate compared to value measured before exercise	Within 2 minutes of completion of the test
Secondary	Change in breathlessness	Change in breathlessness compared to value measured before exercise	Within 2 minutes of completion of the test