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

NCT04771052 | Completed

• 1 other identifier: MP-31-2021-3770
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Length of stay

  Length of stay in COVID and subacute unit (days)

  1 day after discharge

Secondary Outcomes (5)

• Post-discharge destination

  1 day after discharge

• Readmission rate 30 days after discharge

  30 days after discharge

• Change in patient prognosis

  At baseline (± 2 days after admission in the COVID-19 unit) and before discharge (± 3 days)

• Change in functional capacity (lower limb function)

  At baseline (± 2 days after admission in the COVID-19 unit) and before discharge (± 3 days)

• Change in functional capacity (handgrip strength)

  At baseline (± 2 days after admission in the COVID-19 unit) and before discharge (± 3 days)

Study Arms (2)

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)

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).

Interventions

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.

CORE program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (2)

CIUSSS de l'Estrie-Centre hospitalier universitaire de Sherbrooke (CHUS)

Sherbrooke, Quebec, J1J 3H5, Canada

Location

Centre hospitalier affilié universitaire régional (CHAUR)

Trois-Rivières, Quebec, G8Z 3R9, Canada

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 25, 2021
• Study Start: September 1, 2020
• Primary Completion: August 31, 2021
• Study Completion: January 5, 2022
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)