After an acute episode of COVID-19, many patients experience persistent or recurrentsymptoms with substantial impairment of their quality of life. The most common symptomsare fatigue, dyspnea, cognitive impairment and pain, but symptoms of all types have beenreported. The heterogeneity of symptoms and their potential pathophysiology makesindividualized and multidisciplinary management essential.The primary objective of this study is to evaluate the change in quality of life at 6months in patients with persistent symptoms after an acute episode of COVID-19 after 6weeks of personalized multidisciplinary outpatient management versus usual care.
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)
Behavioral: Personalized 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)
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
Hôtel Dieu Hospital
Paris, France
Cédric Lemogne, MD, PhD, Principal Investigator
AP-HP and Université Paris Cité