Covid19CORENCT04771052
Minimizing the Effects of COVID-19 Hospitalization With the COVID Rehabilitation Program for the Elderly
An observational study of Covid19, run by Université de Sherbrooke at 2 sites in Canada.
Trial summary
Although evidence from the management of other viral respiratory infections suggest that early multidisciplinary rehabilitation could mitigate the adverse effects of the severe form of the illness, and reduce the length of hospital stays (LOS), specific data for COVID-19 are lacking. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- What is being tested?
- COVID Rehabilitation Program for the Elderly (CORE)
- Type of treatment
- Pill or oral medicine
- How many people
- 124 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Sep 2020to 5 Jan 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted to the COVID unit at CHUS Hôtel-Dieu de Sherbrooke - CIUSSS de L'Estrie - CHUS (CORE program) or CHAUR de Trois-Rivières, CIUSSS de la Mauricie-et-du-Centre-du-Québec (Controls)
Who may be able to join
- Patients with medical clearance (physical deconditioning; hemodynamically stable; oxygen therapy by nasal cannula < 4 L/min for saturation > 92%; resting respiratory rate < 24; and heart rate between 50 and 120 beats per minute). Controls were paired with those of the CORE program according to age, sex and pre-admission origin
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
CIUSSS de l'Estrie-Centre hospitalier universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, J1J 3H5
Centre hospitalier affilié universitaire régional (CHAUR)
Trois-Rivières, Quebec, G8Z 3R9
About this study
Official title: Minimizing the Effects of COVID-19 Hospitalization With the COVID Rehabilitation Program for the Elderly: the CORE Trial in Response to the Pandemic
Although evidence from the management of other viral respiratory infections suggest that early multidisciplinary rehabilitation could mitigate the adverse effects of the severe form of the illness, and reduce the length of hospital stays (LOS), specific data for COVID-19 are lacking. Hence, in response to the current pandemic, we propose to implement and assess the impact of an early standardized multidisciplinary rehabilitation program tailored to frail older adults on 1) LOS, 2) post-discharge destination, 3) prognostic index and 4) functional capacity.
With a pragmatic multicenter controlled study, the COvid Rehabilitation Program for the Elderly (CORE) trial will allow to measure the effectiveness of a multidisciplinary program to minimize the effects of hospitalization and provide the required tools to rapidly implement an innovative strategy of care for older adults. Indeed, based on the results of this study, and with the support of scientific and professional organizations, a standardized program tailored to older adults with COVID-19 will be disseminated in Canada for all medical units dedicated to the management of the disease. Because of its pragmatic approach, this study will provide a sustainable multidisciplinary intervention that can be quickly implemented in any Canadian (or abroad) COVID-19 medical unit. Finally, given that COVID-19 is the third coronavirus infection in the last 20 years, the expected results will provide guidelines, with decision tree algorithms, for implementation should another coronavirus or for that matter, any other such type of infection that surface in the future.
- Conditions
- Covid19
- Being tested
- COVID Rehabilitation Program for the Elderly (CORE)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID Rehabilitation Program for the Elderly (CORE)Other
In the intervention unit, two teams (core team: physiotherapists and service healthcare workers; specialized team: occupational therapist, registered dietician, social worker) are dedicated to the patients hospitalized in COVID-19 unit. To prevent malnutrition, caused by disease-associated inflammation, the Nutrition as Medicine program (prescribed small doses (30 or 60 mL; 2 kcal/mL) of oral nutrition supplement dispensed with medication pass, 1 to 4 times a day), has been systematically implemented (collective prescription). To improve muscle strength, balance and tissue oxygenation and concomitantly reduce immobilization and risk of falls, each patient has a private pedal exerciser, resistance elastic bands and free weights to perform a progressive, monitored and individualized rehabilitation program thrice a day.
| Study group | Role | What they receive |
|---|---|---|
| CORE program | Patients admitted to a dedicated COVID-19 units (CHUS Hôtel-Dieu de Sherbrooke - CIUSSS de L'Estrie - CHUS) with medical clearance (physical deconditioning; hemodynamically stable; oxygen therapy by nasal cannula < 4 L/min for saturation > 92%; resting respiratory rate < 24; and heart rate between 50 and 120 beats per minute). Receives: Other: COVID Rehabilitation Program for the Elderly (CORE) | |
| Control | Patients admitted to a dedicated COVID-19 units (CHAUR de Trois-Rivières, CIUSSS de la Mauricie-et-du-Centre-du-Québec) receiving usual care, matched to CORE a patient with similar characteristics (sex, age, preadmission provenance). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Length of stay in COVID and subacute unit (days)
Measured: 1 day after discharge
Secondary outcomes (5)
Post-discharge destination
(home; long-term care facilities; death) or transfer to a specialized subacute unit (e.g., rehabilitation geriatric unit)
Measured: 1 day after discharge
Readmission rate 30 days after discharge
Measured: 30 days after discharge
Change in patient prognosis
Evaluated using the COVID-19 vulnerability index (symptoms, medical history, and sociodemographic data)
Measured: At baseline (± 2 days after admission in the COVID-19 unit) and before discharge (± 3 days)
Change in functional capacity (lower limb function)
Lower limb function is assessed using the 5-repetition sit-to-stand test (reported in seconds)
Measured: At baseline (± 2 days after admission in the COVID-19 unit) and before discharge (± 3 days)
Change in functional capacity (handgrip strength)
Handgrip strength is measured using a handgrip dynamometer (reported in kg)
Measured: At baseline (± 2 days after admission in the COVID-19 unit) and before discharge (± 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start1 Sep 2020
- Primary completion31 Aug 2021
- Study completion5 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771052
- Sponsor's protocol ID
- MP-31-2021-3770
- Acronym
- CORE
- Status last verified
- May 2022
- First submitted
- 23 Feb 2021
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Minimizing the Effects of COVID-19 Hospitalization With the COVID Rehabilitation Program for the Elderly: the CORE Trial in Response to the Pandemic
- ClinicalTrials.gov ID
- NCT04771052
- Acronym / sponsor ID
- CORE / MP-31-2021-3770
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 25 Feb 2021 (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.
Although evidence from the management of other viral respiratory infections suggest that early multidisciplinary rehabilitation could mitigate the adverse effects of the severe form of the illness, and reduce the length of hospital stays (LOS), specific data for COVID-19 are lacking. Hence, in response to the current pandemic, we propose to implement and assess the impact of an early standardized multidisciplinary rehabilitation program tailored to frail older adults on 1) LOS, 2) post-discharge destination, 3) prognostic index and 4) functional capacity.
With a pragmatic multicenter controlled study, the COvid Rehabilitation Program for the Elderly (CORE) trial will allow to measure the effectiveness of a multidisciplinary program to minimize the effects of hospitalization and provide the required tools to rapidly implement an innovative strategy of care for older adults. Indeed, based on the results of this study, and with the support of scientific and professional organizations, a standardized program tailored to older adults with COVID-19 will be disseminated in Canada for all medical units dedicated to the management of the disease. Because of its pragmatic approach, this study will provide a sustainable multidisciplinary intervention that can be quickly implemented in any Canadian (or abroad) COVID-19 medical unit. Finally, given that COVID-19 is the third coronavirus infection in the last 20 years, the expected results will provide guidelines, with decision tree algorithms, for implementation should another coronavirus or for that matter, any other such type of infection that surface in the future.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CORE program | – | Other: COVID Rehabilitation Program for the Elderly (CORE)Patients admitted to a dedicated COVID-19 units (CHUS Hôtel-Dieu de Sherbrooke - CIUSSS de L'Estrie - CHUS) with medical clearance (physical deconditioning; hemodynamically stable; oxygen therapy by nasal cannula < 4 L/min for saturation > 92%; resting respiratory rate < 24; and heart rate between 50 and 120 beats per minute). |
| Control | – | –Patients admitted to a dedicated COVID-19 units (CHAUR de Trois-Rivières, CIUSSS de la Mauricie-et-du-Centre-du-Québec) receiving usual care, matched to CORE a patient with similar characteristics (sex, age, preadmission provenance). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to the COVID unit at CHUS Hôtel-Dieu de Sherbrooke - CIUSSS de L'Estrie - CHUS (CORE program) or CHAUR de Trois-Rivières, CIUSSS de la Mauricie-et-du-Centre-du-Québec (Controls)
Key inclusion criteria (1 listed)
- Patients with medical clearance (physical deconditioning; hemodynamically stable; oxygen therapy by nasal cannula < 4 L/min for saturation > 92%; resting respiratory rate < 24; and heart rate between 50 and 120 beats per minute). Controls were paired with those of the CORE program according to age, sex and pre-admission origin
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID Rehabilitation Program for the Elderly (CORE)In the intervention unit, two teams (core team: physiotherapists and service healthcare workers; specialized team: occupational therapist, registered dietician, social worker) are dedicated to the patients hospitalized in COVID-19 unit. To prevent malnutrition, caused by disease-associated inflammation, the Nutrition as Medicine program (prescribed small doses (30 or 60 mL; 2 kcal/mL) of oral nutrition supplement dispensed with medication pass, 1 to 4 times a day), has been systematically implemented (collective prescription). To improve muscle strength, balance and tissue oxygenation and concomitantly reduce immobilization and risk of falls, each patient has a private pedal exerciser, resistance elastic bands and free weights to perform a progressive, monitored and individualized rehabilitation program thrice a day. | Other | CORE program |
Primary outcome
Length of stay
Time frame: 1 day after discharge
Length of stay in COVID and subacute unit (days)
5 secondary outcomes
Post-discharge destination
Time frame: 1 day after discharge
Readmission rate 30 days after discharge
Time frame: 30 days after discharge
Change in patient prognosis
Time frame: At baseline (± 2 days after admission in the COVID-19 unit) and before discharge (± 3 days)
Change in functional capacity (lower limb function)
Time frame: At baseline (± 2 days after admission in the COVID-19 unit) and before discharge (± 3 days)
Change in functional capacity (handgrip strength)
Time frame: At baseline (± 2 days after admission in the COVID-19 unit) and before discharge (± 3 days)
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 23 May 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Université de Sherbrooke at 2 sites 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 1 inclusion and 1 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 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Length of stay (time frame: 1 day after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2022.