Covid19NCT04602260
Functional Recovery of Hospitalised Patients With COVID-19: The COREG Extension Study
An observational study of Covid19 and Corona Virus Infection, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Corona Virus Infection, Mobility Limitation
- How many people
- 211 participants
- Where
- 1 siteCanada
- Study dates
- 9 Jun 2020to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Consecutive patients included in the COREG registry that meet inclusion criteria will be approached for enrollment in this extension study.
Who may be able to join
- 18 years of age or older
- Currently hospitalised/recently discharged due to/since confirmed or suspected COVID- 19 infection using the ISARIC definition.
Who cannot join
- Previously institutionalized
- Pre-morbid severe mobility limitation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Functional Recovery of Older Hospitalised Patients With COVID-19: a Prospective and Retrospective Cohort Study Extension to the Coronavirus Registry (COREG)
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.
Read the detailed description
The coronavirus disease of 2019 (COVID-19) is an international public health challenge with far-reaching social, economic and health impacts. Older adults and those with chronic underlying health conditions are the most susceptible to COVID-19 and its complications. Of the 15,381 reported cases of COVID-19 in Ontario to date, approximately 22.2% (n=3,420) are aged 60-79 and 22.4% (n=3,443) are 80 and over. Although there has been a rapid and coordinated response to studying the effects of COVID-19 in the acute stages, little is known about recovery over the longer-term. Anecdotally, the investigators are seeing severe declines in function, persistent symptoms, and new and worsening chronic conditions among older survivors of COVID-19. It is known that older adults who survive acute respiratory distress syndrome and associated diseases are at risk of developing persistent mobility limitations due to extensive bed rest and/or long stays in the intensive care unit (ICU) during hospitalization. Recent studies have shown that many older patients spend only 4% of their hospital stay out of bed, and each day in bed is associated with a 1-5% loss in muscle strength. 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; with further losses in physiological reserve and resilience. 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.
This study is an extension of the Coronavirus (COVID-19) Registry (COREG) platform (PI Andrew Costa)- a unique Kitchener-Waterloo-Hamilton registry of suspected and confirmed COVID-19 hospital admissions based on (and in collaboration with) the WHO International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). The addition of a prospective cohort study extension to COREG will allow the investigators to follow-older hospitalised COVID-19 patients over the longer-term in order to gain an understanding of the trajectory of functional recovery of the disease. Combining the primary data collection with COREG will also allow the investigators to identify determinants of long-term outcomes for at-risk older adults. These data are necessary to guide the clinical care and optimal management of older patients who survive serious COVID-19 illness.
- Conditions
- Covid19, Corona Virus Infection, Mobility Limitation, Frailty
- Keywords
- mobility, functional recovery, pulmonary function, Covid-19, coronavirus, health outcomes
- Medical subject headings
- COVID-19, Coronavirus Infections, Mobility Limitation, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3,6,9 and 12-months post hospital discharge
Secondary outcomes (13)
Change in Short Physical Performance Battery (SPPB)
The SPPB combines the results of gait speed over 3 meters, the 5-repetition chair-stand, and a progressive balance test to assess lower extremity function.
Measured: 3,6,9 and 12-months post hospital discharge
Change in Clinical Frailty Scale (CFS) for participants over 60 years of age
The CFS is an interview-based scale wherein the assessor may ask the participant questions about things such as a participant's independence or physical abilities to determine where the participant falls along the 9-point scale, from 1 (Very Fit) to 9 (Terminally Ill).
Measured: 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)
The Forced Expiratory Volume in 1 Second parameter measures the volume of air that was exhaled into the mouthpiece in the first second after a full inhalation as measured by spirometry.
Measured: 3,6,9 and 12-months post hospital discharge
Change in Forced Vital Capacity (FVC)
The amount of air that can be forcibly exhaled from a participant's lungs after taking the deepest breath possible, as measured by spirometry. FVC is the total amount of air exhaled during the FEV test.
Measured: 3,6,9 and 12-months post hospital discharge
Change in Forced Expiratory Volume Percentage (FEV1%)
The FEV1/FVC Ratio (FEV1%) parameter is calculated by dividing the measured FEV1 value by the measured FVC value.
Measured: 3,6,9 and 12-months post hospital discharge
Change in Functional Independence Measure (FIM)
The FIM assesses the functional status of a person based on the level of assistance the person requires.
Measured: 3 and 6 months post hospital discharge
Change in Impact of Event Scale - Revised (IES-R)
The IES-R is a 22-item self-report measure that asks questions about subjective distress caused by traumatic events. Each item is rated on a 5-point scale, from 0 ("not at all") to 4 ("extremely").
Measured: 3,6,9 and 12-months post hospital discharge
Change in Health status (EQ-5D-5L)
The EQ-5D-5L is a generic and well-established instrument for describing health status or disease-specific outcome measures. It defines health in terms of five dimensions: Mobility, Self- Care, Usual Activities, Pain/Discomfort, and Anxiety/ Depression. The response options are of five levels, from no, slight, moderate, severe, to extreme problems
Measured: 3,6,9 and 12-months post hospital discharge
Change in Post-COVID-19 Functional Status Scale (PCFSS)
Developed in early 2020, this 5-point scale assesses how individuals have been affected in a participant's everyday life by COVID-19 illness and recovery. Lower grades indicate better functioning, with grade 0 representing the absence of symptoms or functional limitations and grade 4 reflecting severe limitations and symptom burden. The PCFSS can be patient-reported following a flow diagram series of questions to result in a grade, or it can be administered via structured interview, which is more comprehensive. The research team will conduct the structured interview over the phone and the patient-reported flow chart during the home visits.
Measured: 3,6,9 and 12-months post hospital discharge
Change in Hospital Anxiety and Depression Scale (HADS)
The HADS is a 14-item two-dimension scale that identifies depression and anxiety among physically ill patients. Scores range from 0 to 21, with higher scores indicating higher levels of anxiety. In the general ill population, a cut-off of ≥8 indicates depression.
Measured: 3,6,9 and 12-months post hospital discharge
Change in Fatigue Visual Analog Scale (Fatigue VAS)
This visual scale allows individuals to rate a participant's global fatigue from 0 (worst fatigue) to 10 (normal).
Measured: 3,6,9 and 12-months post hospital discharge
Change in Modified Medical Research Council (MRC) Breathlessness Scale
This brief questionnaire contains five statements describing a range of breathlessness from only becoming breathless with strenuous exercise to being too breathless to leave the house.
Measured: 3,6,9 and 12-months post hospital discharge
Change in Oxygen Saturation (SpO2)
Oxygen saturation will be measured using a fingertip pulse oximeter to detect hypoxia and to evaluate any persistent hypoxia post-COVID-19 illness.
Measured: 3,6,9 and 12-months post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start9 Jun 2020
- Primary completion8 Jan 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marla Beauchamp, McMaster University
- Investigators
- Marla K Beauchamp, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602260
- Sponsor's protocol ID
- COREG-Extension_14567
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2020
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34903545Kreuzberger 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.
PubMed 34473343
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Recovery of Older Hospitalised Patients With COVID-19: a Prospective and Retrospective Cohort Study Extension to the Coronavirus Registry (COREG)
- ClinicalTrials.gov ID
- NCT04602260
- Acronym / sponsor ID
- COREG-Extension_14567
- Conditions
- Covid19, Corona Virus Infection, Mobility Limitation, Frailty
- Keywords
- mobility, functional recovery, pulmonary function, Covid-19, coronavirus, health outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 26 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The coronavirus disease of 2019 (COVID-19) is an international public health challenge with far-reaching social, economic and health impacts. Older adults and those with chronic underlying health conditions are the most susceptible to COVID-19 and its complications. Of the 15,381 reported cases of COVID-19 in Ontario to date, approximately 22.2% (n=3,420) are aged 60-79 and 22.4% (n=3,443) are 80 and over. Although there has been a rapid and coordinated response to studying the effects of COVID-19 in the acute stages, little is known about recovery over the longer-term. Anecdotally, the investigators are seeing severe declines in function, persistent symptoms, and new and worsening chronic conditions among older survivors of COVID-19. It is known that older adults who survive acute respiratory distress syndrome and associated diseases are at risk of developing persistent mobility limitations due to extensive bed rest and/or long stays in the intensive care unit (ICU) during hospitalization. Recent studies have shown that many older patients spend only 4% of their hospital stay out of bed, and each day in bed is associated with a 1-5% loss in muscle strength. 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; with further losses in physiological reserve and resilience. 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.
This study is an extension of the Coronavirus (COVID-19) Registry (COREG) platform (PI Andrew Costa)- a unique Kitchener-Waterloo-Hamilton registry of suspected and confirmed COVID-19 hospital admissions based on (and in collaboration with) the WHO International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC). The addition of a prospective cohort study extension to COREG will allow the investigators to follow-older hospitalised COVID-19 patients over the longer-term in order to gain an understanding of the trajectory of functional recovery of the disease. Combining the primary data collection with COREG will also allow the investigators to identify determinants of long-term outcomes for at-risk older adults. These data are necessary to guide the clinical care and optimal management of older patients who survive serious COVID-19 illness.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients included in the COREG registry that meet inclusion criteria will be approached for enrollment in this extension study.
Key inclusion criteria (2 listed)
- 18 years of age or older
- Currently hospitalised/recently discharged due to/since confirmed or suspected COVID- 19 infection using the ISARIC definition.
Key exclusion criteria (2 listed)
- Previously institutionalized
- Pre-morbid severe mobility limitation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Activity Measure for Post Acute Care (AM-PAC) Basic Mobility Inpatient Version
Time frame: 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)
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.
Change in Activity Measure for Post Acute Care (AM-PAC) Basic Mobility Outpatient Version
Time frame: 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
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.
Change in Activity Measure for Post Acute Care (AM-PAC) Applied Cognitive Inpatient Version
Time frame: 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)
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.
Change in Activity Measure for Post Acute Care (AM-PAC) Daily Activity
Time frame: 3,6,9 and 12-months post hospital discharge
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.
13 secondary outcomes
Change in Short Physical Performance Battery (SPPB)
Time frame: 3,6,9 and 12-months post hospital discharge
Change in Clinical Frailty Scale (CFS) for participants over 60 years of age
Time frame: 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)
Time frame: 3,6,9 and 12-months post hospital discharge
Change in Forced Vital Capacity (FVC)
Time frame: 3,6,9 and 12-months post hospital discharge
Change in Forced Expiratory Volume Percentage (FEV1%)
Time frame: 3,6,9 and 12-months post hospital discharge
Change in Functional Independence Measure (FIM)
Time frame: 3 and 6 months post hospital discharge
Change in Impact of Event Scale - Revised (IES-R)
Time frame: 3,6,9 and 12-months post hospital discharge
Change in Health status (EQ-5D-5L)
Time frame: 3,6,9 and 12-months post hospital discharge
Change in Post-COVID-19 Functional Status Scale (PCFSS)
Time frame: 3,6,9 and 12-months post hospital discharge
Change in Hospital Anxiety and Depression Scale (HADS)
Time frame: 3,6,9 and 12-months post hospital discharge
Change in Fatigue Visual Analog Scale (Fatigue VAS)
Time frame: 3,6,9 and 12-months post hospital discharge
Change in Modified Medical Research Council (MRC) Breathlessness Scale
Time frame: 3,6,9 and 12-months post hospital discharge
Change in Oxygen Saturation (SpO2)
Time frame: 3,6,9 and 12-months post hospital discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Derived from this study: PubMed 34903545Reid 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.
- Derived from this study: PubMed 34473343Kreuzberger 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marla K Beauchamp, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Corona Virus Infection, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Activity Measure for Post Acute Care (AM-PAC) Basic Mobility Inpatient Version (time frame: 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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04602260, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.