Functional Recovery of Hospitalised Patients With COVID-19: The COREG Extension Study

NCT04602260 | Completed

• 1 other identifier: COREG-Extension_14567
• Study Type: observational
• Target: 211
• Locations: 1 country
• Sites: 1

Brief Summary

Older adults and those with chronic underlying health conditions are the most susceptible to COVID-19 and its complications. Although there has been a rapid response to studying the effects of COVID-19 in the acute stages, little is known about recovery over the longer-term. Older adults who survive the diseases are at risk of developing persistent mobility limitations due to extensive bed rest during hospitalization. For older patients and those with underlying frailty recovering from COVID-19, this could rapidly lead to significant physical deconditioning and rapid declines in mobility. Understanding the trajectory of functional recovery of older hospitalised patients with COVID-19 in the short- and long-term is critical to improving patient outcomes and informing health and rehabilitative interventions for survivors.

Conditions

Covid19; Corona Virus Infection; Mobility Limitation; Frailty

Keywords

mobility; functional recovery; pulmonary function; Covid-19; coronavirus; health outcomes

Outcome Measures

Primary Outcomes (4)

• Change in Activity Measure for Post Acute Care (AM-PAC) Basic Mobility Inpatient Version

  The AM-PAC is an activity limitation instrument based on the International Classification of Functioning, Disability and Health (ICF) that assesses 3 functional domains: basic mobility, daily activities and applied cognition.

  Admission to hospital ward (0-14 days post ward admission) and discharge from hospital (0-14 days post discharge or up to 6 months, whichever comes first)

• Change in Activity Measure for Post Acute Care (AM-PAC) Basic Mobility Outpatient Version

  The AM-PAC is an activity limitation instrument based on the International Classification of Functioning, Disability and Health (ICF) that assesses 3 functional domains: basic mobility, daily activities and applied cognition.

  Admission to hospital ward (0-14 days post ward admission, to capture pre-morbid function), and at 3,6,9 and 12-months post hospital discharge

• Change in Activity Measure for Post Acute Care (AM-PAC) Applied Cognitive Inpatient Version

  The AM-PAC is an activity limitation instrument based on the International Classification of Functioning, Disability and Health (ICF) that assesses 3 functional domains: basic mobility, daily activities and applied cognition.

  Admission to hospital ward (0-14 days post ward admission) and discharge from hospital (0-14 days post discharge or up to 6 months, whichever comes first)

• Change in Activity Measure for Post Acute Care (AM-PAC) Daily Activity

  The AM-PAC is an activity limitation instrument based on the International Classification of Functioning, Disability and Health (ICF) that assesses 3 functional domains: basic mobility, daily activities and applied cognition.

  3,6,9 and 12-months post hospital discharge

Secondary Outcomes (13)

• Change in Short Physical Performance Battery (SPPB)

  3,6,9 and 12-months post hospital discharge

• Change in Clinical Frailty Scale (CFS) for participants over 60 years of age

  Admission to hospital ward (0-14 days post ward admission, to capture pre-morbid function ), and at 3,6,9 and 12-months post hospital discharge

• Change in Forced Expiratory Volume (FEV1)

  3,6,9 and 12-months post hospital discharge

• Change in Forced Vital Capacity (FVC)

  3,6,9 and 12-months post hospital discharge

• Change in Forced Expiratory Volume Percentage (FEV1%)

  3,6,9 and 12-months post hospital discharge

Study Arms (2)

Prospective Cohort

The prospective cohort will assess patients upon admission to general internal medicine, at hospital discharge, and at 3, 6, 9, and 12-month follow-up.

Retrospective Cohort

The retrospective cohort will assess patients at 3, 6, 9, and 12-months after being discharged from the hospital.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients included in the COREG registry that meet inclusion criteria will be approached for enrollment in this extension study.

You may qualify if:

• years of age or older
• Currently hospitalised/recently discharged due to/since confirmed or suspected COVID- 19 infection using the ISARIC definition.

You may not qualify if:

• Previously institutionalized
• Pre-morbid severe mobility limitation

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S1C7, Canada

Location

Related Publications (2)

• Reid JC, Costa AP, Duong M, Ho T, Kruisselbrink R, Raina P, Kirkwood R, Jones A, Corriveau S, Griffith LE, Haider S, Marcucci M, Markle-Reid M, Morrison H, Raghavan N, Schumacher C, Vrkljan B, Junek M, Martin L, Patel A, Girolametto C, Pitre T, Beauchamp MK; COREG Investigators. Functional recovery following hospitalisation of patients diagnosed with COVID-19: a protocol for a longitudinal cohort study. BMJ Open. 2021 Dec 13;11(12):e053021. doi: 10.1136/bmjopen-2021-053021.

  PMID: 34903545 DERIVED

• Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

  PMID: 34473343 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Mobility Limitation; Frailty

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• Marla K Beauchamp, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: October 26, 2020
• Study Start: June 9, 2020
• Primary Completion: January 8, 2024
• Study Completion: March 31, 2024
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)