Physical and Cognitive Impairments in People Suffering From Long COVID

NCT05216536 | Completed

• 1 other identifier: 2022-2328
• Study Type: observational
• Target: 360
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (61)

• Comorbidities

  Baseline

• Sleep Quality

  Baseline

• Sleep Quality

  3-month follow-up

• Sleep Quality

  6-month follow-up

• Pain & Pain-Related Disabilities

  Baseline

Study Arms (3)

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

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

Control

Adults who did not contract COVID-19.

Other: No intervention

Interventions

No intervention OTHER

No intervention

Acute COVID; Control; Long COVID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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®).

You may qualify if:

• For all 3 groups: 18 years of age or older and being able to participate in 3 evaluation sessions within 6 months
• 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

You may not qualify if:

• \- None

Sponsors & Collaborators

• Laval University: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Université Laval

Québec, G1V 0A6, Canada

Location

Related Publications (1)

• 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.

  PMID: 36921943 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Cognitive Dysfunction; Signs and Symptoms; Post-Acute COVID-19 Syndrome; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pathological Conditions, Signs and Symptoms; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; Graft vs Host Disease; Immune System Diseases

Study Officials

• Jean-Sébastien Roy, PT, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 31, 2022
• Study Start: January 2, 2022
• Primary Completion: September 19, 2023
• Study Completion: September 19, 2023
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)