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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19; Quality of Life; Cognitive Impairment; Cognitive Dysfunction; Corona Virus Infection; Physical Disability; SARS-CoV-2 Infection; Impairment; Symptoms and Signs
• Intervention / Treatment: Other: No intervention

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 Type: Observational
• Enrollment (Actual): 360

Contacts and Locations

Study Locations

• Canada
  • Québec, Canada, G1V 0A6
    • Université Laval

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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®).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: No intervention; No intervention
Acute COVID; Adults who contracted COVID-19 but did not experience persistent symptoms for more than 4 weeks following the initial diagnosis.	Other: No intervention; No intervention
Control; Adults who did not contract COVID-19.	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	6-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comorbidities	Self- Administered Comorbidity Questionnaire (SCQ): generic questionnaire with 13 common medical conditions.	Baseline
Sleep Quality	Pittsburgh Sleep Quality Index (PSQI): evaluates the quality and patterns of sleep over the last month.	Baseline
Sleep Quality	Pittsburgh Sleep Quality Index (PSQI): evaluates the quality and patterns of sleep over the last month.	3-month follow-up
Sleep Quality	Pittsburgh Sleep Quality Index (PSQI): evaluates the quality and patterns of sleep over the last month.	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.	Baseline
Pain & Pain-Related Disabilities	Brief Pain Inventory Short Form (BPI-SF): designed to evaluate the intensity of, and the impairment caused by pain.	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.	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.	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.	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.	6-month follow-up
Depressive symptoms	Patient-Health Questionnaire (PHQ-9): assesses the nine symptoms of a major depressive episode.	Baseline
Depressive symptoms	Patient-Health Questionnaire (PHQ-9): assesses the nine symptoms of a major depressive episode.	3-month follow-up
Depressive symptoms	Patient-Health Questionnaire (PHQ-9): assesses the nine symptoms of a major depressive episode.	6-month follow-up
Fatigue	Fatigue Severity Scale (FSS): measures the severity of fatigue and its effect on a person's activities and lifestyle	Baseline
Fatigue	Fatigue Severity Scale (FSS): measures the severity of fatigue and its effect on a person's activities and lifestyle	3-month follow-up
Fatigue	Fatigue Severity Scale (FSS): measures the severity of fatigue and its effect on a person's activities and lifestyle	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	6-month follow-up
Cognitive function - information processing and executive functioning	Trail Making Test: assesses speed of information processing and executive functioning.	Baseline
Cognitive function - information processing and executive functioning	Trail Making Test: assesses speed of information processing and executive functioning.	3-month follow-up
Cognitive function - information processing and executive functioning	Trail Making Test: assesses speed of information processing and executive functioning.	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.	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.	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.	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).	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).	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).	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.	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.	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.	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).	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).	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).	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).	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).	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).	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.	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.	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.	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	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	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	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	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	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	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	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	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	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	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	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	6-month follow-up

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Jean-Sebastien Roy, PT, PhD, Laval University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2022
• Primary Completion (Actual): September 19, 2023
• Study Completion (Actual): September 19, 2023

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Physical fitness; Persistent; Function; Health-related quality of life; Chronic; Sequelae; Physical health; Long covid; Long-haul; Post-acute; Limitation
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Neurocognitive Disorders; Disease Attributes; Cognition Disorders; Chronic Disease; Post-Infectious Disorders; COVID-19; Coronavirus Infections; Infections; Communicable Diseases; Cognitive Dysfunction; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: 2022-2328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No