Trials / Completed

CompletedNCT05216536

Physical and Cognitive Impairments in People Suffering From Long COVID

Better Understanding Physical and Cognitive Impairments and Functional Limitations in People Suffering From Long COVID to Support the Development of Adapted Interventions

Status: Completed
Phase: —
Study type: Observational
Enrollment: 360 (actual)

Sponsor: Laval University · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Accepted

Summary

Of the 1,900,000 Canadians who have been infected by COVID-19, 8 to 15% will continue to experience COVID-19 related symptoms well after 12 weeks. The persistence of such symptoms is now defined as "long COVID" syndrome. Current evidence does not provide a clear understanding of the physical and cognitive impairments and functional limitations that persons with long COVID present. The objectives of this project are to describe the physical and cognitive impairments and functional limitations experienced by people with long COVID and compare the evolution over 6 months of people from three separate groups: a group of people with long COVID (long COVID Group), another group of people who contracted COVID-19 but did not experience persistent symptoms (acute COVID Group), and a group of people who did not contract COVID-19 (Control Group). One hundred and twenty adults in each of the three groups will be recruited and will take part in three evaluations within 6 months (baseline and 3 and 6 months after baseline). At baseline, all participants will complete questionnaires on sociodemographics, COVID symptomatology and comorbidity, and self-reported questionnaires on quality of life, functional status, sleep, pain-related disabilities, anxiety, depression, fatigue and cognitive function. Then, physical and cognitive tests will be performed in a laboratory to provide complementary results on impairments and functional limitations. Finally, participants will wear a fitness tracker watch to monitor their activity and sleep for 7 days. The participants will complete the same measures (questionnaires, lab measures, fitness tracker watch) at 3 and 6 months after baseline evaluations. This project will lead to a better understanding of the impairments/limitations experienced following COVID-19. Hence, these results will allow to identify the interventions needed by the population and ensure these are offered through effective healthcare pathways.

Detailed description

The objectives of this study are to: describe the physical and cognitive impairments and functional limitations experienced by individuals with long COVID using self-reported and objective clinical measures and compare the evolution over time of the physical and cognitive state and level of functioning between: a) people with long COVID, b) people who contracted COVID-19 but did not experience persistent symptoms, and c) people who did not contract COVID-19. One hundred and twenty adults with long COVID symptoms (Long COVID Group), 120 age- and sex-matched adults who contracted COVID-19 but did not experience persistent symptoms (Acute COVID Group) and 120 age- and sex-matched adults who did not contract COVID-19 (Control Group) will take part in three evaluations within 6 months (baseline and 3 and 6 months after baseline). The baseline evaluation will include 1) the completion of web-based self-administered questionnaires (quality of life, functional status, sleep, pain-related disabilities, anxiety, depression, fatigue and cognitive function); 2) an in-lab session at one of the two participating research centers (Centre interdisciplinaire de recherche en réadaptation et en intégration sociale \[Cirris\] in Quebec City, Centre de recherche de l'Hôpital Maisonneuve-Rosemont \[CRHMR\] in Montreal) during which participants will answer questions on sociodemographics, COVID-19 medical history and symptoms experienced, and will perform clinical tests to objectify cognitive and physical impairments and functional limitations (attention, memory, executive functioning, grip strength, balance, gait speed and endurance, oxygen consumption \[VO2\] and metabolic cost of walking), and 3) wearing a fitness tracker watch to monitor activity and sleep for 7 days. The participants will complete the same measures (questionnaires, lab measures, fitness tracker watch) at three and 6 months after baseline evaluation Statistical analyses for objective 1 will aim at presenting a sociodemographic and COVID history profiles of the Long COVID Group at baseline according to sex, gender, hospitalization, time since onset and comorbidities. Scores at baseline on self-reported and clinical variables will also be compared with the Acute COVID and Control Groups via three-group One-way ANOVA (maximum-likelihood ANOVA). For objective 2, repeated measures ANOVA will be used to compare the divergence in longitudinal performance across groups in self-reported and clinical variables (generalized ANOVA for repeated measures). Gaining a greater understanding of the physical and cognitive state and level of functioning of persons with long COVID and on characteristics of those who will have a poorer outcome will help better define healthcare needs of these persons and guide the development of appropriate medical and rehabilitation interventions. Best practices in terms of medical and rehabilitation services in cases of long COVID are still just emerging and offering appropriate services to persons suffering from long COVID may contribute to improving outcomes such as long-term physical and cognitive impairments and functional limitations, as well as health-related quality of life.

Conditions

Interventions

Type	Name	Description
OTHER	No intervention	No intervention

Timeline

Start date: 2022-01-02
Primary completion: 2023-09-19
Completion: 2023-09-19
First posted: 2022-01-31
Last updated: 2024-03-13

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT05216536. Inclusion in this directory is not an endorsement.