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NCT Number: NCT04771052

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Length of stay

    Time frame: 1 day after discharge

    Length of stay in COVID and subacute unit (days)

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

Minimizing the Effects of COVID-19 Hospitalization With the COVID Rehabilitation Program for the Elderly: the CORE Trial in Response to the Pandemic

Acronym: CORE

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 25, 2021
Registry last updated
May 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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