COVID-19NCT05216536
Physical and Cognitive Impairments in People Suffering From Long COVID
An observational study of COVID-19 and SARS-CoV-2 Infection, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, SARS-CoV-2 Infection, Corona Virus Infection
- How many people
- 360 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jan 2022to 19 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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®).
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Better Understanding Physical and Cognitive Impairments and Functional Limitations in People Suffering From Long COVID to Support the Development of Adapted Interventions
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.
Read the 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
- COVID-19, SARS-CoV-2 Infection, Corona Virus Infection, Physical Disability, Cognitive Impairment, Cognitive Dysfunction
- Being tested
- No intervention
- Keywords
- Long covid, Long-haul, Chronic, Post-acute, Sequelae, Persistent, Physical health, Physical fitness, Function, Limitation, Health-related quality of life
- Medical subject headings
- COVID-19, Coronavirus Infections, Cognitive Dysfunction, Signs and Symptoms, Post-Acute COVID-19 Syndrome, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Long COVID | Adults who contracted COVID-19 and present at least one physical or cognitive long COVID-19 symptom for more than 12 weeks following the initial diagnosis. Receives: Other: No intervention | |
| Acute COVID | Adults who contracted COVID-19 but did not experience persistent symptoms for more than 4 weeks following the initial diagnosis. Receives: Other: No intervention | |
| Control | Adults who did not contract COVID-19. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life (HRQoL) baseline
5-level EQ-5D (EQ-5D-5L): generic HRQoL self-reported questionnaire that contains 5 questions covering 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression
Measured: Baseline
Health-related quality of life (HRQoL) at 3 months
5-level EQ-5D (EQ-5D-5L): generic HRQoL self-reported questionnaire that contains 5 questions covering 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression
Measured: 3-month follow-up
Health-related quality of life (HRQoL) at 6 months
5-level EQ-5D (EQ-5D-5L): generic HRQoL self-reported questionnaire that contains 5 questions covering 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression
Measured: 6-month follow-up
Secondary outcomes (61)
Comorbidities
Self- Administered Comorbidity Questionnaire (SCQ): generic questionnaire with 13 common medical conditions.
Measured: Baseline
Sleep Quality
Pittsburgh Sleep Quality Index (PSQI): evaluates the quality and patterns of sleep over the last month.
Measured: Baseline
Sleep Quality
Pittsburgh Sleep Quality Index (PSQI): evaluates the quality and patterns of sleep over the last month.
Measured: 3-month follow-up
Sleep Quality
Pittsburgh Sleep Quality Index (PSQI): evaluates the quality and patterns of sleep over the last month.
Measured: 6-month follow-up
Pain & Pain-Related Disabilities
Brief Pain Inventory Short Form (BPI-SF): designed to evaluate the intensity of, and the impairment caused by pain.
Measured: Baseline
Pain & Pain-Related Disabilities
Brief Pain Inventory Short Form (BPI-SF): designed to evaluate the intensity of, and the impairment caused by pain.
Measured: 3-month follow-up
Pain & Pain-Related Disabilities
Brief Pain Inventory Short Form (BPI-SF): designed to evaluate the intensity of, and the impairment caused by pain.
Measured: 6-month follow-up
Anxiety
General Anxiety Disorder (GAD-7): assesses the seven core symptoms of generalized anxiety disorder by asking how frequent participants have been bothered by symptoms of anxiety.
Measured: Baseline
Anxiety
General Anxiety Disorder (GAD-7): assesses the seven core symptoms of generalized anxiety disorder by asking how frequent participants have been bothered by symptoms of anxiety.
Measured: 3-month follow-up
Anxiety
General Anxiety Disorder (GAD-7): assesses the seven core symptoms of generalized anxiety disorder by asking how frequent participants have been bothered by symptoms of anxiety.
Measured: 6-month follow-up
Depressive symptoms
Patient-Health Questionnaire (PHQ-9): assesses the nine symptoms of a major depressive episode.
Measured: Baseline
Depressive symptoms
Patient-Health Questionnaire (PHQ-9): assesses the nine symptoms of a major depressive episode.
Measured: 3-month follow-up
Depressive symptoms
Patient-Health Questionnaire (PHQ-9): assesses the nine symptoms of a major depressive episode.
Measured: 6-month follow-up
Fatigue
Fatigue Severity Scale (FSS): measures the severity of fatigue and its effect on a person's activities and lifestyle
Measured: Baseline
Fatigue
Fatigue Severity Scale (FSS): measures the severity of fatigue and its effect on a person's activities and lifestyle
Measured: 3-month follow-up
Fatigue
Fatigue Severity Scale (FSS): measures the severity of fatigue and its effect on a person's activities and lifestyle
Measured: 6-month follow-up
Self-reported cognitive function
Patient Reported Outcomes Measurement Information System (PROMIS): the PROMIS Short Form v2.0 - Cognitive Function measures perceived changes in cognitive function.
Measured: Baseline
Self-reported cognitive function
Patient Reported Outcomes Measurement Information System (PROMIS): the PROMIS Short Form v2.0 - Cognitive Function measures perceived changes in cognitive function.
Measured: 3-month follow-up
Self-reported cognitive function
Patient Reported Outcomes Measurement Information System (PROMIS): the PROMIS Short Form v2.0 - Cognitive Function measures perceived changes in cognitive function.
Measured: 6-month follow-up
Persistent symptoms
Newcastle post-COVID syndrome Follow Up Screening Questionnaire: identifies individuals who are experiencing residuals COVID-19 related symptoms and for who multi-disciplinary management or specialist support may be beneficial.
Measured: Baseline (long COVID group only)
Persistent symptoms
Newcastle post-COVID syndrome Follow Up Screening Questionnaire: identifies individuals who are experiencing residuals COVID-19 related symptoms and for who multi-disciplinary management or specialist support may be beneficial.
Measured: 3-month follow-up (long COVID group only)
Persistent symptoms
Newcastle post-COVID syndrome Follow Up Screening Questionnaire: identifies individuals who are experiencing residuals COVID-19 related symptoms and for who multi-disciplinary management or specialist support may be beneficial.
Measured: 6-month follow-up (long COVID group only)
Cognitive function - MoCA
MoCA: assesses short term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language and orientation in time and place.
Measured: Baseline
Cognitive function - MoCA
MoCA: assesses short term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language and orientation in time and place.
Measured: 3-month follow-up
Cognitive function - MoCA
MoCA: assesses short term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language and orientation in time and place.
Measured: 6-month follow-up
Cognitive function - auditory attention and working memory
Digit Span subtest of the WAIS-IV battery (including forward and Backward tasks): assesses auditory attention and working memory.
Measured: Baseline
Cognitive function - auditory attention and working memory
Digit Span subtest of the WAIS-IV battery (including forward and Backward tasks): assesses auditory attention and working memory.
Measured: 3-month follow-up
Cognitive function - auditory attention and working memory
Digit Span subtest of the WAIS-IV battery (including forward and Backward tasks): assesses auditory attention and working memory.
Measured: 6-month follow-up
Cognitive function - information processing and executive functioning
Trail Making Test: assesses speed of information processing and executive functioning.
Measured: Baseline
Cognitive function - information processing and executive functioning
Trail Making Test: assesses speed of information processing and executive functioning.
Measured: 3-month follow-up
Cognitive function - information processing and executive functioning
Trail Making Test: assesses speed of information processing and executive functioning.
Measured: 6-month follow-up
Grip strength
Grip Strength: Grip strength of both hands will be measured using a handgrip dynamometer. Grip strength is associated with concurrent overall strength, upper limb function and quality of life. Three trials will be performed, and the maximum strength reached will be used in the subsequent analysis.
Measured: Baseline
Grip strength
Grip Strength: Grip strength of both hands will be measured using a handgrip dynamometer. Grip strength is associated with concurrent overall strength, upper limb function and quality of life. Three trials will be performed, and the maximum strength reached will be used in the subsequent analysis.
Measured: 3-month follow-up
Grip strength
Grip Strength: Grip strength of both hands will be measured using a handgrip dynamometer. Grip strength is associated with concurrent overall strength, upper limb function and quality of life. Three trials will be performed, and the maximum strength reached will be used in the subsequent analysis.
Measured: 6-month follow-up
Lower extremity function (including balance, gait speed and lower extremity strength)
Short performance physical battery (SPPB): The SPPB is a short (5-10 min) test to measure lower extremity function using tasks that mimic daily activities. It examines 3 areas of lower extremity function, including static standing balance (3 timed standing positions), gait speed (time to complete 4m walk), and getting in and out of a chair (time to complete 5x sit to stand).
Measured: Baseline
Lower extremity function (including balance, gait speed and lower extremity strength)
Short performance physical battery (SPPB): The SPPB is a short (5-10 min) test to measure lower extremity function using tasks that mimic daily activities. It examines 3 areas of lower extremity function, including static standing balance (3 timed standing positions), gait speed (time to complete 4m walk), and getting in and out of a chair (time to complete 5x sit to stand).
Measured: 3-month follow-up
Lower extremity function (including balance, gait speed and lower extremity strength)
Short performance physical battery (SPPB): The SPPB is a short (5-10 min) test to measure lower extremity function using tasks that mimic daily activities. It examines 3 areas of lower extremity function, including static standing balance (3 timed standing positions), gait speed (time to complete 4m walk), and getting in and out of a chair (time to complete 5x sit to stand).
Measured: 6-month follow-up
Gait endurance
6-minute walk test (6MWT): The 6MWT will be performed in a 15 to 20-meter corridor and the distance covered will be measured with a measuring wheel.
Measured: Baseline
Gait endurance
6-minute walk test (6MWT): The 6MWT will be performed in a 15 to 20-meter corridor and the distance covered will be measured with a measuring wheel.
Measured: 3-month follow-up
Gait endurance
6-minute walk test (6MWT): The 6MWT will be performed in a 15 to 20-meter corridor and the distance covered will be measured with a measuring wheel.
Measured: 6-month follow-up
Oxygen consumption (VO2)
Oxygen consumption (VO2) will be measured during the 6WMT using indirect calorimetry collected by a portable gas analysis system (Metamax® 3b).
Measured: Baseline
Oxygen consumption (VO2)
Oxygen consumption (VO2) will be measured during the 6WMT using indirect calorimetry collected by a portable gas analysis system (Metamax® 3b).
Measured: 3-month follow-up
Oxygen consumption (VO2)
Oxygen consumption (VO2) will be measured during the 6WMT using indirect calorimetry collected by a portable gas analysis system (Metamax® 3b).
Measured: 6-month follow-up
Metabolic cost of walking
Metabolic cost of walking will be measured during the 6WMT using indirect calorimetry collected by a portable gas analysis system (Metamax® 3b).
Measured: Baseline
Metabolic cost of walking
Metabolic cost of walking will be measured during the 6WMT using indirect calorimetry collected by a portable gas analysis system (Metamax® 3b).
Measured: 3-month follow-up
Metabolic cost of walking
Metabolic cost of walking will be measured during the 6WMT using indirect calorimetry collected by a portable gas analysis system (Metamax® 3b).
Measured: 6-month follow-up
Frailty
Clinical Frailty Scale (CFS): The CFS is a scale used to grade frailty and thus, identify participants who are at a higher risk of poor outcomes.
Measured: Baseline
Frailty
Clinical Frailty Scale (CFS): The CFS is a scale used to grade frailty and thus, identify participants who are at a higher risk of poor outcomes.
Measured: 3-month follow-up
Frailty
Clinical Frailty Scale (CFS): The CFS is a scale used to grade frailty and thus, identify participants who are at a higher risk of poor outcomes.
Measured: 6-month follow-up
Physical activity - Number of steps in real-life environment
Participants will be asked to wear a fitness tracker watch (Garmin Forerunner 35) 24 hrs/day for 7 consecutive days after each of the three physical evaluations. The average daily number of steps will be retrieved
Measured: Baseline
Physical activity - Number of steps in real-life environment
Participants will be asked to wear a fitness tracker watch (Garmin Forerunner 35) 24 hrs/day for 7 consecutive days after each of the three physical evaluations. The average daily number of steps will be retrieved
Measured: 3-month follow-up
Physical activity - Number of steps in real-life environment
Participants will be asked to wear a fitness tracker watch (Garmin Forerunner 35) 24 hrs/day for 7 consecutive days after each of the three physical evaluations. The average daily number of steps will be retrieved
Measured: 6-month follow-up
Physical activity - Weekly number of minutes of moderate and intense activity in real-life environment
Participants will be asked to wear a fitness tracker watch (Garmin Forerunner 35) 24 hrs/day for 7 consecutive days after each of the three physical evaluations.The weekly number of minutes of moderate and intense activity will be retrieved
Measured: Baseline
Physical activity - Weekly number of minutes of moderate and intense activity inreal-life environment
Participants will be asked to wear a fitness tracker watch (Garmin Forerunner 35) 24 hrs/day for 7 consecutive days after each of the three physical evaluations.The weekly number of minutes of moderate and intense activity will be retrieved
Measured: 3-month follow-up
Physical activity - Weekly number of minutes of moderate and intense activity in real-life environment
Participants will be asked to wear a fitness tracker watch (Garmin Forerunner 35) 24 hrs/day for 7 consecutive days after each of the three physical evaluations.The weekly number of minutes of moderate and intense activity will be retrieved
Measured: 6-month follow-up
Sleep: Sleep time in real-life environment
Participants will be asked to wear a fitness tracker watch (Garmin Forerunner 35) 24 hrs/day for 7 consecutive days after each of the three physical evaluations. The sleep time will be retrieved from the fitness tracker watch
Measured: Baseline
Sleep: Sleep time in real-life environment
Participants will be asked to wear a fitness tracker watch (Garmin Forerunner 35) 24 hrs/day for 7 consecutive days after each of the three physical evaluations. The sleep time will be retrieved from the fitness tracker watch
Measured: 3-month follow-up
Sleep: Sleep time in real-life environment
Participants will be asked to wear a fitness tracker watch (Garmin Forerunner 35) 24 hrs/day for 7 consecutive days after each of the three physical evaluations. The sleep time will be retrieved from the fitness tracker watch
Measured: 6-month follow-up
Sleep: Sleep efficiency in real-life environment
Participants will be asked to wear a fitness tracker watch (Garmin Forerunner 35) 24 hrs/day for 7 consecutive days after each of the three physical evaluations. The sleep efficiency will be retrieved from the fitness tracker watch
Measured: Baseline
Sleep: Sleep efficiency in real-life environment
Participants will be asked to wear a fitness tracker watch (Garmin Forerunner 35) 24 hrs/day for 7 consecutive days after each of the three physical evaluations. The sleep efficiency will be retrieved from the fitness tracker watch
Measured: 3-month follow-up
Sleep: Sleep efficiency in real-life environment
Participants will be asked to wear a fitness tracker watch (Garmin Forerunner 35) 24 hrs/day for 7 consecutive days after each of the three physical evaluations. The sleep efficiency will be retrieved from the fitness tracker watch
Measured: 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start2 Jan 2022
- Primary completion19 Sep 2023
- Study completion19 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Jean-Sébastien Roy, PT, PhD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216536
- Sponsor's protocol ID
- 2022-2328
- Status last verified
- Mar 2024
- First submitted
- 14 Jan 2022
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zahouani I, Desmeules F, Perreault K, Campeau-Lecours A, Best K, Beaulieu-Bonneau S, Paquette JS, Deslauriers S, Daigle N, Drouin G, Tittley J, Gagnon MA, Salmam I, Brouillard SM, Lepage K, Roy JS. Physical and cognitive impairments in people suffering from long COVID: protocol for a longitudinal population-based cohort study. BMJ Open. 2023 Mar 15;13(3):e064054. doi: 10.1136/bmjopen-2022-064054.
PubMed 36921943
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Understanding Physical and Cognitive Impairments and Functional Limitations in People Suffering From Long COVID to Support the Development of Adapted Interventions
- ClinicalTrials.gov ID
- NCT05216536
- Acronym / sponsor ID
- 2022-2328
- Conditions
- COVID-19, SARS-CoV-2 Infection, Corona Virus Infection, Physical Disability, Cognitive Impairment, Cognitive Dysfunction
- Keywords
- Long covid, Long-haul, Chronic, Post-acute, Sequelae, Persistent, Physical health, Physical fitness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 19 Sep 2023 (actual)
- Study completion
- 19 Sep 2023 (actual)
- First posted
- 31 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Long COVID | – | Other: No interventionAdults who contracted COVID-19 and present at least one physical or cognitive long COVID-19 symptom for more than 12 weeks following the initial diagnosis. |
| Acute COVID | – | Other: No interventionAdults who contracted COVID-19 but did not experience persistent symptoms for more than 4 weeks following the initial diagnosis. |
| Control | – | Other: No interventionAdults who did not contract COVID-19. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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®).
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Acute COVID, Control, Long COVID |
Primary outcome
Health-related quality of life (HRQoL) baseline
Time frame: Baseline
5-level EQ-5D (EQ-5D-5L): generic HRQoL self-reported questionnaire that contains 5 questions covering 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression
Health-related quality of life (HRQoL) at 3 months
Time frame: 3-month follow-up
5-level EQ-5D (EQ-5D-5L): generic HRQoL self-reported questionnaire that contains 5 questions covering 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression
Health-related quality of life (HRQoL) at 6 months
Time frame: 6-month follow-up
5-level EQ-5D (EQ-5D-5L): generic HRQoL self-reported questionnaire that contains 5 questions covering 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression
61 secondary outcomes
Comorbidities
Time frame: Baseline
Sleep Quality
Time frame: Baseline
Sleep Quality
Time frame: 3-month follow-up
Sleep Quality
Time frame: 6-month follow-up
Pain & Pain-Related Disabilities
Time frame: Baseline
Pain & Pain-Related Disabilities
Time frame: 3-month follow-up
Pain & Pain-Related Disabilities
Time frame: 6-month follow-up
Anxiety
Time frame: Baseline
Anxiety
Time frame: 3-month follow-up
Anxiety
Time frame: 6-month follow-up
Depressive symptoms
Time frame: Baseline
Depressive symptoms
Time frame: 3-month follow-up
Depressive symptoms
Time frame: 6-month follow-up
Fatigue
Time frame: Baseline
Fatigue
Time frame: 3-month follow-up
Fatigue
Time frame: 6-month follow-up
Self-reported cognitive function
Time frame: Baseline
Self-reported cognitive function
Time frame: 3-month follow-up
Self-reported cognitive function
Time frame: 6-month follow-up
Persistent symptoms
Time frame: Baseline (long COVID group only)
Persistent symptoms
Time frame: 3-month follow-up (long COVID group only)
Persistent symptoms
Time frame: 6-month follow-up (long COVID group only)
Cognitive function - MoCA
Time frame: Baseline
Cognitive function - MoCA
Time frame: 3-month follow-up
Cognitive function - MoCA
Time frame: 6-month follow-up
Cognitive function - auditory attention and working memory
Time frame: Baseline
Cognitive function - auditory attention and working memory
Time frame: 3-month follow-up
Cognitive function - auditory attention and working memory
Time frame: 6-month follow-up
Cognitive function - information processing and executive functioning
Time frame: Baseline
Cognitive function - information processing and executive functioning
Time frame: 3-month follow-up
Cognitive function - information processing and executive functioning
Time frame: 6-month follow-up
Grip strength
Time frame: Baseline
Grip strength
Time frame: 3-month follow-up
Grip strength
Time frame: 6-month follow-up
Lower extremity function (including balance, gait speed and lower extremity strength)
Time frame: Baseline
Lower extremity function (including balance, gait speed and lower extremity strength)
Time frame: 3-month follow-up
Lower extremity function (including balance, gait speed and lower extremity strength)
Time frame: 6-month follow-up
Gait endurance
Time frame: Baseline
Gait endurance
Time frame: 3-month follow-up
Gait endurance
Time frame: 6-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Derived from this study: PubMed 36921943Zahouani I, Desmeules F, Perreault K, Campeau-Lecours A, Best K, Beaulieu-Bonneau S, Paquette JS, Deslauriers S, Daigle N, Drouin G, Tittley J, Gagnon MA, Salmam I, Brouillard SM, Lepage K, Roy JS. Physical and cognitive impairments in people suffering from long COVID: protocol for a longitudinal population-based cohort study. BMJ Open. 2023 Mar 15;13(3):e064054. doi: 10.1136/bmjopen-2022-064054.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Sébastien Roy, PT, PhD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and SARS-CoV-2 Infection, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (HRQoL) baseline (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05216536, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.