Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Minimizing the Effects of COVID-19 Hospitalization With the COVID Rehabilitation Program for the Elderly (CORE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04771052
Recruitment Status : Enrolling by invitation
First Posted : February 25, 2021
Last Update Posted : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
Université de Sherbrooke

Brief 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. 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.


Condition or disease Intervention/treatment
Covid19 Other: COVID Rehabilitation Program for the Elderly (CORE)

Layout table for study information
Study Type : Observational
Estimated Enrollment : 128 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Group/Cohort Intervention/treatment
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).
Other: 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.

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).



Primary Outcome Measures :
  1. Length of stay [ Time Frame: 1 day after discharge ]
    Length of stay in COVID and subacute unit (days)


Secondary Outcome Measures :
  1. Post-discharge destination [ Time Frame: 1 day after discharge ]
    (home; long-term care facilities; death) or transfer to a specialized subacute unit (e.g., rehabilitation geriatric unit)

  2. Readmission rate 30 days after discharge [ Time Frame: 30 days after discharge ]
  3. Change in patient prognosis [ Time Frame: At baseline (± 2 days after admission in the COVID-19 unit) and before discharge (± 3 days) ]
    Evaluated using the COVID-19 vulnerability index (symptoms, medical history, and sociodemographic data)

  4. 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) ]
    Lower limb function is assessed using the 5-repetition sit-to-stand test (reported in seconds)

  5. Change in functional capacity (handgrip strength) [ Time Frame: At baseline (± 2 days after admission in the COVID-19 unit) and before discharge (± 3 days) ]
    Handgrip strength is measured using a handgrip dynamometer (reported in kg)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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)
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04771052


Locations
Layout table for location information
Canada, Quebec
CIUSSS de l'Estrie-Centre hospitalier universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, Canada, J1J 3H5
Centre hospitalier affilié universitaire régional (CHAUR)
Trois-Rivières, Quebec, Canada, G8Z 3R9
Sponsors and Collaborators
Université de Sherbrooke
Layout table for additonal information
Responsible Party: Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT04771052    
Other Study ID Numbers: MP-31-2021-3770
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No