Inpatient, multimodal rehabilitation represents one of the most important interventions in the disease management of post/long COVID. Different professional societies, including the German Society of Pneumology and the European Respiratory Society, recommend rehabilitation intervention to reduce the sequelae of COVID-19. However, from the perspective of science and practice, there are relevant areas that have been insufficiently investigated and are essential for the treatment success of post/long COVID patients: * Differentiation of rehabilitation effects from natural recovery after COVID-19. * Lack of personalized and symptom-based treatment approaches that can address the heterogeneity of symptoms in post/long COVID * Lack of uniform, high-quality rehabilitation standards in post-/long-COVID. Therefore, post-COVID patients will be recruited at several post-COVID practices around Germany and randomized to receive (A) a rehabilitation program or (B) usual care. The primary objective of this randomized controlled trial (RCT) is to investigate whether a 3-week symptom-oriented, inpatient, multidisciplinary rehabilitation intervention, whose content focus is standardized according to cluster assignment (fatigue, cognition, soma), has a positive effect on the quality of life (primary outcome) in post-COVID syndrome patients compared to a usual care group (standard outpatient care). All study participants will be provided with a continuous telemonitoring system (SaniQ app) throughout the study period. After the interventional phase, there will be a 3 months follow-up assessment to evaluate the maintenance effects of COVID rehabilitation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
132
Patients in this arm will be referred to a 3-week inpatient comprehensive rehabilitation program. Initially, patients will be classified into one out of three clusters namely: Cluster A (Fatigue), Cluster B (cognition), or Cluster C (physical). The content of the rehabilitation program will be individually adapted according to the patient's most relevant symptom cluster.
Patients in this arm do not receive any intervention beyond usual care during the study phase. However, all patients in this group will get the opportunity to also receive a rehabilitation program after the study phase.
University Hospital Augsburg
Augsburg, Germany
Praxis Dr. Schrag
Bad Reichenhall, Germany
Pneumologen Lichterfelde Berlin
Berlin, Germany
Praxis im Zentrum Erlangen
Erlangen, Germany
Pneumopraxis Marburg
Marburg, Germany
Lungenärzte am Rundfunkplatz, München
Munich, Germany
COVID ambulance Prof. Koczulla
Schönau am Königssee, Germany
Praxis Dr. Roch
Schwabach, Germany
Change from baseline Quality of life assessed by Short Form - 12 Questionnaire at week 4 and week 12
the scale of the physical and mental Health component summary score ranges from minimum 0 to maximum 100 points with higher scores indicating better quality of life
Time frame: baseline, week 4, week 12
Change from baseline COVID-related symptoms at week 4 and week 12
the number of COVID-symptoms will recorded as well as their intensity will be rated on a scale from 0 \[not relevant\] until 10 \[very severe symptom\].
Time frame: baseline, week 4, week 12
Change from baseline lung function at week 4 and week 12
following Parameters will be collected: forced expiratory volume in 1 sec, peak flow, forced vital capacity, total lung capacity, diffusion lung capacity for carbonmonoxide
Time frame: baseline, week 4, week 12
Change from baseline blood gas analysis at week 4 and week 12
following parameters will be collected at rest and at the end of an incremental cycle test: partial pressure for oxygen and carbon dioxide
Time frame: baseline, week 4, week 12
Change from baseline Cardiac Doppler echocardiography at week 4 and week 12
Left and right heart echocardiography will be performed
Time frame: baseline, week 4, week 12
Change from baseline laboratory parameters at week 4 and week 12
blood samples will be taken from venous blood
Time frame: baseline, week 4, week 12
Change from baseline exercise performance at week 4 and week 12
incremental cardiopulmonary exercise testing will be performed with spirometry
Time frame: baseline, week 4, week 12
Change from baseline health care service needs at week 4 and week 12
Number of visits at the general practitioner, pulmonologist, psychologist, physiotherapist, COVID-ambulance, hospital admission until the last visit will be recorded
Time frame: baseline, week 4, week 12
Change from baseline working capability at week 4 and week 12
number of days of incapacity to work until the last visit will be recorded
Time frame: baseline, week 4, week 12
Change from baseline sleep quality at week 4 and week 12
Sleep quality will be assessed by using the Pittsburgh Sleep Quality Index (total score ranges from 0 to 21 with higher scores indicating higher impairment)
Time frame: baseline, week 4, week 12
Change from baseline sleep quality at week 4 and week 12
daytime sleepiness will be assessed by using the Epworth Sleepiness Scale (total score ranges from 0 to 24 with higher scores indicating higher impairment)
Time frame: baseline, week 4, week 12
Change from baseline Depression status assessed by Patient Health Questionnaire 9
the total score ranges from 0 to 27 points with higher scores indicating worse Depression symptoms
Time frame: baseline, week 4, week 12
Change from baseline Anxiety status assessed by Generalized Anxiety Disorder Scale 7
the total score ranges from 0 to 21 points with higher scores indicating more anxiety symptoms
Time frame: baseline, week 4, week 12
Change from baseline resilience assessed by resilience scale 13
the total score ranges from 13 to 91 points with higher scores indicating higher resilience
Time frame: baseline, week 4, week 12
Change from baseline cognitive status assessed by Montreal Cognitive Assessment Test
the total score ranges from 0 to 30 points with higher scores indicating a better cognitive status
Time frame: baseline, week 4, week 12
Change from baseline dyspnea assessed by Modified Medical Research Counsil score at week 4 and week 12
the total score ranges from 0 to 4 points with higher scores indicating more dyspnea
Time frame: baseline, week 4, week 12
Change from baseline dysfunctional breathing assessed by Nijmegen breathing questionnaire at week 4 and week 12
the total score ranges from 0 to 64 points with higher scores indicating hyperventilation
Time frame: baseline, week 4, week 12
Change from baseline chronic fatigue syndrome assessed by fatigue assessment scale at week 4 and week 12
the total score ranges from 10 to 50 points with higher scores indicating more fatigue
Time frame: baseline, week 4, week 12
Change from baseline chronic fatigue syndrome assessed by canadian consensus criteria at week 12
the canadian consensus criteria indicate if patients developed a chronic fatigue syndrome/myalgic encephalomyelitis
Time frame: baseline, week 12
Change from baseline functional status assessed by post-COVID functional status scale at week 4 and week 12
the total score ranges from 0 to 4 points with higher scores indicating more impairment
Time frame: baseline, week 4, week 12
Change from baseline physical activity assessed by Garmin watch at week 4 and week 12
daily total steps per day will be recorded by a Garmin watch linked to the SaniQ App
Time frame: baseline, week 4, week 12
Change from baseline blood pressure assessed at week 4 and week 12
blood pressure will be measured at the upper arm using the Aponorm device
Time frame: baseline, week 4, week 12
Change from baseline oxygen saturation assessed by pulse oximeter at week 4 and week 12
Beurer pulse oximeter
Time frame: baseline, week 4, week 12
Change from baseline peak flow assessed by peak flow meter at week 4 and week 12
peak flow will be assessed by smart one spirometer
Time frame: baseline, week 4, week 12
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