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

Covid19 Clinical Trial

— CORE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04771052
• Other study ID #: MP-31-2021-3770
• Status: Completed
• Start date: September 1, 2020
• Est. completion date: January 5, 2022

Study information

• Verified date: May 2022
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: January 5, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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.

Locations

Country	Name	City	State
Canada	CIUSSS de l'Estrie-Centre hospitalier universitaire de Sherbrooke (CHUS)	Sherbrooke	Quebec
Canada	Centre hospitalier affilié universitaire régional (CHAUR)	Trois-Rivières	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay	Length of stay in COVID and subacute unit (days)	1 day after discharge
Secondary	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
Secondary	Readmission rate 30 days after discharge		30 days after discharge
Secondary	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)
Secondary	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)
Secondary	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)