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

February 23, 2021 updated by: Dr Christian P Subbe, Betsi Cadwaladr University Health Board

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Emergency presentations
Patients discharged after a presentation to practitioners in the community, primary and secondary care.
Diagnostic test: 40-Steps-test
40 steps performed on the spot

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours
Hospital
Time Frame: 30 days
Admission to hospital within 30 days of the test
30 days
Death
Time Frame: 30 days
Death within 30 days of the test
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Betsi Cadwaladr University Health Board

Collaborators

Oxford Brookes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2021

Primary Completion (Anticipated)

November 3, 2021

Study Completion (Anticipated)

November 3, 2021

Study Registration Dates

First Submitted

October 31, 2020

First Submitted That Met QC Criteria

November 5, 2020

First Posted (Actual)

November 6, 2020

Study Record Updates

Last Update Posted (Actual)

February 24, 2021

Last Update Submitted That Met QC Criteria

February 23, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 283998

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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