Clinical trial NCT05216536: Physical and Cognitive Impairments in People Suffering From Long COVID
Official title: Better Understanding Physical and Cognitive Impairments and Functional Limitations in People Suffering From Long COVID to Support the Development of Adapted Interventions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
SARS-CoV-2 Infection
Corona Virus Infection
Physical Disability
Cognitive Impairment
Cognitive Dysfunction
Quality of Life
Symptoms and Signs
Impairment
Keywords: Long covid
Long-haul
Chronic
Post-acute
Sequelae
Persistent
Physical health
Physical fitness
Function
Limitation
Health-related quality of life
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2022-01-31
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 be recruited through medical clinics in Quebec City and Montreal (e.g., Academic family medicine groups \[FMG-U\] and long COVID Clinics), invitations in newsletters sent to healthcare workers of CIUSSS de la Capitale-Nationale and CIUSSS de l'Est-de-l'Île-de-Montréal, electronic mailing lists of students, employees and retired employees at Université Laval (\> 52,000 individuals), and social media (Facebook®, Instagram®).

Brief 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.

Eligibility criteria: Inclusion Criteria

* For all 3 groups: 18 years of age or older and being able to participate in 3 evaluation sessions within 6 months
* For the COVID Groups: having received a diagnosis of COVID-19 from a government designated testing clinic or hospital at least 12 weeks prior to inclusion.
* For the Long COVID Group: presenting at least one physical or cognitive long COVID-19 symptom for more than 12 weeks following the initial diagnosis such as fatigue, shortness of breath, muscle weakness, joint pain, headache, cognitive dysfunction, or sleep-related difficulties
* For the Acute COVID Group: not have experienced any persistent symptom for more than 4 weeks after having contracted COVID- 19
* For the Control Group: not have received a diagnosis of COVID-19 and not have experienced COVID-19 symptoms since February 2020 such as fever, sudden loss of smell, headache, dyspnea, great fatigue, muscle or body aches, shortness of breath or sore throat

Exclusion criteria:

- None

Primary outcomes:
measure: Health-related quality of life (HRQoL) baseline
timeFrame: Baseline
measure: Health-related quality of life (HRQoL) at 3 months
timeFrame: 3-month follow-up
measure: Health-related quality of life (HRQoL) at 6 months
timeFrame: 6-month follow-up
Secondary outcomes:
measure: Comorbidities
timeFrame: Baseline
measure: Sleep Quality
timeFrame: Baseline
measure: Sleep Quality
timeFrame: 3-month follow-up
measure: Sleep Quality
timeFrame: 6-month follow-up
measure: Pain & Pain-Related Disabilities
timeFrame: Baseline
measure: Pain & Pain-Related Disabilities
timeFrame: 3-month follow-up
measure: Pain & Pain-Related Disabilities
timeFrame: 6-month follow-up
measure: Anxiety
timeFrame: Baseline
measure: Anxiety
timeFrame: 3-month follow-up
measure: Anxiety
timeFrame: 6-month follow-up
measure: Depressive symptoms
timeFrame: Baseline
measure: Depressive symptoms
timeFrame: 3-month follow-up
measure: Depressive symptoms
timeFrame: 6-month follow-up
measure: Fatigue
timeFrame: Baseline
measure: Fatigue
timeFrame: 3-month follow-up
measure: Fatigue
timeFrame: 6-month follow-up
measure: Self-reported cognitive function
timeFrame: Baseline
measure: Self-reported cognitive function
timeFrame: 3-month follow-up
measure: Self-reported cognitive function
timeFrame: 6-month follow-up
measure: Persistent symptoms
timeFrame: Baseline (long COVID group only)
measure: Persistent symptoms
timeFrame: 3-month follow-up (long COVID group only)
measure: Persistent symptoms
timeFrame: 6-month follow-up (long COVID group only)
measure: Cognitive function - MoCA
timeFrame: Baseline
measure: Cognitive function - MoCA
timeFrame: 3-month follow-up
measure: Cognitive function - MoCA
timeFrame: 6-month follow-up
measure: Cognitive function - auditory attention and working memory
timeFrame: Baseline
measure: Cognitive function - auditory attention and working memory
timeFrame: 3-month follow-up
measure: Cognitive function - auditory attention and working memory
timeFrame: 6-month follow-up
measure: Cognitive function - information processing and executive functioning
timeFrame: Baseline
measure: Cognitive function - information processing and executive functioning
timeFrame: 3-month follow-up
measure: Cognitive function - information processing and executive functioning
timeFrame: 6-month follow-up
measure: Grip strength
timeFrame: Baseline
measure: Grip strength
timeFrame: 3-month follow-up
measure: Grip strength
timeFrame: 6-month follow-up
measure: Lower extremity function (including balance, gait speed and lower extremity strength)
timeFrame: Baseline
measure: Lower extremity function (including balance, gait speed and lower extremity strength)
timeFrame: 3-month follow-up
measure: Lower extremity function (including balance, gait speed and lower extremity strength)
timeFrame: 6-month follow-up
measure: Gait endurance
timeFrame: Baseline
measure: Gait endurance
timeFrame: 3-month follow-up
measure: Gait endurance
timeFrame: 6-month follow-up
measure: Oxygen consumption (VO2)
timeFrame: Baseline
measure: Oxygen consumption (VO2)
timeFrame: 3-month follow-up
measure: Oxygen consumption (VO2)
timeFrame: 6-month follow-up
measure: Metabolic cost of walking
timeFrame: Baseline
measure: Metabolic cost of walking
timeFrame: 3-month follow-up
measure: Metabolic cost of walking
timeFrame: 6-month follow-up
measure: Frailty
timeFrame: Baseline
measure: Frailty
timeFrame: 3-month follow-up
measure: Frailty
timeFrame: 6-month follow-up
measure: Physical activity - Number of steps in real-life environment
timeFrame: Baseline
measure: Physical activity - Number of steps in real-life environment
timeFrame: 3-month follow-up
measure: Physical activity - Number of steps in real-life environment
timeFrame: 6-month follow-up
measure: Physical activity - Weekly number of minutes of moderate and intense activity in real-life environment
timeFrame: Baseline
measure: Physical activity - Weekly number of minutes of moderate and intense activity inreal-life environment
timeFrame: 3-month follow-up
measure: Physical activity - Weekly number of minutes of moderate and intense activity in real-life environment
timeFrame: 6-month follow-up
measure: Sleep: Sleep time in real-life environment
timeFrame: Baseline
measure: Sleep: Sleep time in real-life environment
timeFrame: 3-month follow-up
measure: Sleep: Sleep time in real-life environment
timeFrame: 6-month follow-up
measure: Sleep: Sleep efficiency in real-life environment
timeFrame: Baseline
measure: Sleep: Sleep efficiency in real-life environment
timeFrame: 3-month follow-up
measure: Sleep: Sleep efficiency in real-life environment
timeFrame: 6-month follow-up
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Université Laval
Study officials:
affiliation: Laval University
name: Jean-Sébastien Roy, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: