Post COVID-19 Condition
Conditions
Keywords
Randomized controlled trial, Cognitive behavior therapy, Physical exercise, Cognitive remediation, Post covid-19 condition
Brief summary
After an acute episode of COVID-19, many patients experience persistent or recurrent symptoms with substantial impairment of their quality of life. The most common symptoms are fatigue, dyspnea, cognitive impairment and pain, but symptoms of all types have been reported. The heterogeneity of symptoms and their potential pathophysiology makes individualized and multidisciplinary management essential. The primary objective of this study is to evaluate the change in quality of life at 6 months in patients with persistent symptoms after an acute episode of COVID-19 after 6 weeks of personalized multidisciplinary outpatient management versus usual care.
Detailed description
After an acute episode of COVID-19, many patients experience persistent or recurrent symptoms with substantial impairment of their quality of life. The most common symptoms are fatigue, dyspnea, cognitive impairment, and pain, but symptoms of all types have been reported. The heterogeneity of symptoms and their potential pathophysiology makes individualized and multidisciplinary management essential. The primary objective is to evaluate the change in quality of life at 6 months in patients with persistent symptoms after an acute episode of COVID-19 after 6 weeks of personalized multidisciplinary outpatient management versus usual care. The secondary objectives are to evaluate the evolution of the quality of life at 3 months, the evolution of the main persistent symptoms (fatigue, dyspnea, cognitive complaints, pain), the patients' satisfaction, the predictive and explanatory factors of the evolution. This is a prospective randomized open-label study in two parallel arms: personalized multidisciplinary outpatient intervention versus usual care (waiting list). This 6-week program of care will include: * group education sessions including a psycho-education component (1 session / week) * a personalized exercise training protocol (from 1 session of supervision to 3 sessions of guided exercise per week) adapted to the results of the VO2max exercise test * if dysfunctional health beliefs are identified (SSD-12 score ≥ 26): group cognitive and behavior therapy (2 sessions per week, including at least 1 in person). * if cognitive complaints and/or neuropsychological impairment: a cognitive remediation protocol (1 group session plus 2 home sessions per week)
Interventions
BEHAVIORALPersonalized multidisciplinary day-hospital intervention
This 6-week program of care will include: * group education sessions including a psycho-education component (1 session / week) * a personalized exercise training protocol (from 1 session of supervision to 3 sessions of guided exercise per week) adapted to the results of the VO2max exercise test. * if dysfunctional health beliefs are identified (SSD-12 score ≥ 26): a group protocol of cognitive and behavior therapy (2 sessions per week, including at least 1 in person). * if cognitive complaints and/or neuropsychological impairment: a cognitive remediation protocol (1 group session plus 2 home sessions per week)
Sponsors
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Having had an initial episode of symptomatic COVID-19 according to one of the following criteria: * SARS-Cov-2 PCR + * SARS-Cov-2 + antigenic test * SARS-Cov-2 + serology * Prolonged anosmia/ageusia of sudden onset * Typical chest CT scan * Still having at least one of the initial symptoms and possibly new symptoms including fatigue, dyspnea, cognitive impairment or pain beyond 4 weeks after the onset of the acute phase of the disease. * These initial and persistent symptoms are not better explained by another diagnosis not known to be related to Covid-19. * These symptoms are the cause of an alteration in quality of life and global functioning deemed significant by the patient. * Having an indication to either supervised exercise and / or cognitive behavior therapy and / or cognitive remediation
Exclusion criteria
* Medical emergency requiring management not compatible with research * Neuropsychiatric disorder likely to alter cognitive functions, prior to the Covid-19 episode * Medical contraindication to exercise training such as pericarditis or progressive myocarditis * Patient under state medical assistance * Patient who does not speak French * Pregnancy in progress
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | at 6 Months | SF-12 global score - 12-item Short Form Survey (SF-12) is a general health questionnaire. Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | at 3 Months | SF-12 global score - 12-item Short Form Survey (SF-12) is a general health questionnaireTwo summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12) |
| Fatigue | at 3 months, 6 months | Pichot's scale global score - may vary between 0 and 32. A score above 22 reveals excessive fatigue |
| Dyspnea | at 3 months, 6 months | Borg scale (0 min-10 max) |
| Cognitive complaint | at 3 months, 6 months | Mac Nair \& Kahn (1983) cognitive difficulties questionnaire, French GRECO consensus version |
| Pain | at 3 months, 6 months | Numerical rating scale - from 0 (no pain) to 10 (the maximum imaginable pain) |
| Patient's satisfaction | at 3 months, 6 months | Ad hoc questionnaire |
| Physical fitness | at inclusion, 3 months, 6 months | Global physical activity questionnaire (GPAQ) score |
| Post-effort heart rate | at inclusion, 3 months, 6 months | Difference between estimated and measured heart rate (HR) at the end of the walking test |
| Weight loss | at inclusion, 3 months, 6 months | % weight loss |
| BMI | at inclusion, 3 months, 6 months | BMI |
| Blood albumin | at inclusion, 3 months, 6 months | Blood albumin |
| Nutritional risk | at inclusion, 3 months, 6 months | Nutritional risk index |
| Health beliefs associated with persistent symptoms | at inclusion, 3 months, 6 months | SSD-12 global score- may vary between 0 and 48 points - Each of the three psychological sub-criteria of DSM-5 somatic symptom disorder (cognitive, affective, behavioral) is measured by four items with all item scores ranging between 0 and 4 (0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = very often) Ratings are summed up to make a simple sum score |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORCédric Lemogne, MD, PhD
AP-HP and Université Paris Cité
Outcome results
None listed