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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Other: COVID Rehabilitation Program for the Elderly (CORE)

• Study Type: Observational
• Enrollment (Actual): 124

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Sherbrooke, Quebec, Canada, J1J 3H5
      • CIUSSS de l'Estrie-Centre hospitalier universitaire de Sherbrooke (CHUS)
    • Trois-Rivières, Quebec, Canada, G8Z 3R9
      • Centre hospitalier affilié universitaire régional (CHAUR)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Length of stay in COVID and subacute unit (days)	1 day after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-discharge destination	(home; long-term care facilities; death) or transfer to a specialized subacute unit (e.g., rehabilitation geriatric unit)	1 day after discharge
Readmission rate 30 days after discharge		30 days after discharge
Change in patient prognosis	Evaluated using the COVID-19 vulnerability index (symptoms, medical history, and sociodemographic data)	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)	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)	At baseline (± 2 days after admission in the COVID-19 unit) and before discharge (± 3 days)

Collaborators and Investigators

• Sponsor: Université de Sherbrooke

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): January 5, 2022

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 24, 2021
• First Posted (Actual): February 25, 2021

Study Record Updates

• Last Update Posted (Actual): May 23, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: MP-31-2021-3770

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