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| Name | Class |
|---|---|
| Bavarian State Office for Health and Food Safety | UNKNOWN |
| Praxis im Zentrum Erlangen | UNKNOWN |
| Pneumologen Lichterfelde Berlin | UNKNOWN |
| Pneumopraxis Marburg |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symptom-focused Rehabilitation | Active Comparator | 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. |
|
| Usual Care | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| symptom-focused rehabilitation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, week 4, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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]. | baseline, week 4, week 12 |
| Change from baseline lung function at week 4 and week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Augsburg | Augsburg | Germany | ||||
| Praxis Dr. Schrag |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42161418 | Derived | Schneeberger T, Jarosch I, Kroll D, Gloeckl R, Schneider C, Ulm B, Schwaiblmair M, Lampert S, Greulich T, Schoenherr I, Schultz T, Schrag T, Dennis CJ, Koczulla AR. Symptom-based rehabilitation in people with post-COVID-19 condition (RELOAD study): a randomised controlled trial. BMJ Open Respir Res. 2026 May 20;13(1):e004177. doi: 10.1136/bmjresp-2026-004177. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| UNKNOWN |
| COVID ambulance Philipps-University Marburg | UNKNOWN |
| Pneumologie Elisenhof Munich | UNKNOWN |
| Ludwig-Maximilians - University of Munich | OTHER |
| University Clinic Augsburg | UNKNOWN |
| COVID ambulance Schön Klinik Schönau | UNKNOWN |
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The statistician will be blinded
|
| usual care | Other | 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. |
|
following Parameters will be collected: forced expiratory volume in 1 sec, peak flow, forced vital capacity, total lung capacity, diffusion lung capacity for carbonmonoxide |
| 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 | 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 | baseline, week 4, week 12 |
| Change from baseline laboratory parameters at week 4 and week 12 | blood samples will be taken from venous blood | 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 | 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 | 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 | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | baseline, week 4, week 12 |
| Change from baseline oxygen saturation assessed by pulse oximeter at week 4 and week 12 | Beurer pulse oximeter | 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 | baseline, week 4, week 12 |
| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |