RELOAD: Symptom-based Rehabilitation Compared to Usual Care in Post-COVID - a Randomized Controlled Trial
Study Details
Study Description
Brief Summary
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:
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Differentiation of rehabilitation effects from natural recovery after COVID-19.
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Lack of personalized and symptom-based treatment approaches that can address the heterogeneity of symptoms in post/long COVID
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Symptom-focused Rehabilitation 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. |
Other: symptom-focused rehabilitation
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.
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| Other: Usual Care 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. |
Other: usual care
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.
|
Outcome Measures
Primary Outcome Measures
- Change from baseline Quality of life assessed by Short Form - 12 Questionnaire at week 4 and week 12 [baseline, week 4, 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
Secondary Outcome Measures
- Change from baseline COVID-related symptoms at week 4 and week 12 [baseline, week 4, 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].
- Change from baseline lung function at week 4 and week 12 [baseline, week 4, 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
- Change from baseline blood gas analysis at week 4 and week 12 [baseline, week 4, 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
- Change from baseline Cardiac Doppler echocardiography at week 4 and week 12 [baseline, week 4, week 12]
Left and right heart echocardiography will be performed
- Change from baseline laboratory parameters at week 4 and week 12 [baseline, week 4, week 12]
blood samples will be taken from venous blood
- Change from baseline exercise performance at week 4 and week 12 [baseline, week 4, week 12]
incremental cardiopulmonary exercise testing will be performed with spirometry
- Change from baseline health care service needs at week 4 and week 12 [baseline, week 4, week 12]
Number of visits at the general practitioner, pulmonologist, psychologist, physiotherapist, COVID-ambulance, hospital admission until the last visit will be recorded
- Change from baseline working capability at week 4 and week 12 [baseline, week 4, week 12]
number of days of incapacity to work until the last visit will be recorded
- Change from baseline sleep quality at week 4 and week 12 [baseline, week 4, 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)
- Change from baseline sleep quality at week 4 and week 12 [baseline, week 4, 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)
- Change from baseline Depression status assessed by Patient Health Questionnaire 9 [baseline, week 4, week 12]
the total score ranges from 0 to 27 points with higher scores indicating worse Depression symptoms
- Change from baseline Depression status assessed by Generalized Anxiety Disorder Scale 7 [baseline, week 4, week 12]
the total score ranges from 0 to 21 points with higher scores indicating more anxiety symptoms
- Change from baseline resilience assessed by resilience scale 13 [baseline, week 4, week 12]
the total score ranges from 13 to 91 points with higher scores indicating higher resilience
- Change from baseline cognitive status assessed by Montreal Cognitive Assessment Test [baseline, week 4, week 12]
the total score ranges from 0 to 30 points with higher scores indicating a better cognitive status
- Change from baseline dyspnea assessed by Modified Medical Research Counsil score at week 4 and week 12 [baseline, week 4, week 12]
the total score ranges from 0 to 4 points with higher scores indicating more dyspnea
- Change from baseline dysfunctional breathing assessed by Nijmegen breathing questionnaire at week 4 and week 12 [baseline, week 4, week 12]
the total score ranges from 0 to 64 points with higher scores indicating hyperventilation
- Change from baseline chronic fatigue syndrome assessed by fatigue assessment scale at week 4 and week 12 [baseline, week 4, week 12]
the total score ranges from 10 to 50 points with higher scores indicating more fatigue
- Change from baseline chronic fatigue syndrome assessed by canadian consensus criteria at week 12 [baseline, week 12]
the canadian consensus criteria indicate if patients developed a chronic fatigue syndrome/myalgic encephalomyelitis
- Change from baseline functional status assessed by post-COVID functional status scale at week 4 and week 12 [baseline, week 4, week 12]
the total score ranges from 0 to 4 points with higher scores indicating more impairment
- Change from baseline physical activity assessed by Garmin watch at week 4 and week 12 [baseline, week 4, week 12]
daily total steps per day will be recorded by a Garmin watch linked to the SaniQ App
- Change from baseline blood pressure assessed at week 4 and week 12 [baseline, week 4, week 12]
blood pressure will be measured at the upper arm using the Aponorm device
- Change from baseline oxygen saturation assessed by pulse oximeter at week 4 and week 12 [baseline, week 4, week 12]
Beurer pulse oximeter
- Change from baseline peak flow assessed by peak flow meter at week 4 and week 12 [baseline, week 4, week 12]
peak flow will be assessed by smart one spirometer
Eligibility Criteria
Criteria
Inclusion Criteria:
- Post-COVID Syndrome according to World Health Organisation definition (persistent symptoms for at least 3 months after PCR-test confirmed SARS-CoV 2 infection)
Exclusion Criteria:
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no walking ability
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not able to operate smartphone apps
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rehabilitation program within the previous 6 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Augsburg | Augsburg | Germany | ||
| 2 | Praxis Dr. Schrag | Bad Reichenhall | Germany | ||
| 3 | Pneumologen Lichterfelde Berlin | Berlin | Germany | ||
| 4 | Praxis im Zentrum Erlangen | Erlangen | Germany | ||
| 5 | Pneumopraxis Marburg | Marburg | Germany | ||
| 6 | Lungenärzte am Rundfunkplatz, München | Munich | Germany | ||
| 7 | Praxis Dr. Roch | Schwabach | Germany | ||
| 8 | COVID ambulance Prof. Koczulla | Schönau am Königssee | Germany |
Sponsors and Collaborators
- Schön Klinik Berchtesgadener Land
- Bavarian State Office for Health and Food Safety
- Praxis im Zentrum Erlangen
- Pneumologen Lichterfelde Berlin
- Pneumopraxis Marburg
- COVID ambulance Philipps-University Marburg
- Pneumologie Elisenhof Munich
- COVID ambulance Pneumology LMU Munich
- COVID ambulance psychology LMU Munich
- University Clinic Augsburg
- COVID ambulance Schön Klinik Schönau
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RELOAD