Clinical trial NCT05172206: Symptom-based Rehabilitation Compared to Usual Care in Post-COVID - a Randomized Controlled Trial
Official title: Symptom-based Rehabilitation Compared to Usual Care in Post-COVID - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Long-COVID
Keywords: rehabilitation
intervention
quality of life
long-COVID
post-COVID syndrome
sequelae
recovery
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
Collaborators: name: Bavarian State Office for Health and Food Safety
name: Praxis im Zentrum Erlangen
name: Pneumologen Lichterfelde Berlin
name: Pneumopraxis Marburg
name: COVID ambulance Philipps-University Marburg
name: Pneumologie Elisenhof Munich
name: COVID ambulance Pneumology LMU Munich
name: COVID ambulance psychology LMU Munich
name: University Clinic Augsburg
name: COVID ambulance Schön Klinik Schönau
First posted: 2021-12-29
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

* 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.


Eligibility 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:

* no walking ability
* not able to operate smartphone apps
* rehabilitation program within the previous 6 months

Primary outcomes:
measure: Change from baseline Quality of life assessed by Short Form - 12 Questionnaire at week 4 and week 12
timeFrame: baseline, week 4, week 12
Secondary outcomes:
measure: Change from baseline COVID-related symptoms at week 4 and week 12
timeFrame: baseline, week 4, week 12
measure: Change from baseline lung function at week 4 and week 12
timeFrame: baseline, week 4, week 12
measure: Change from baseline blood gas analysis at week 4 and week 12
timeFrame: baseline, week 4, week 12
measure: Change from baseline Cardiac Doppler echocardiography at week 4 and week 12
timeFrame: baseline, week 4, week 12
measure: Change from baseline laboratory parameters at week 4 and week 12
timeFrame: baseline, week 4, week 12
measure: Change from baseline exercise performance at week 4 and week 12
timeFrame: baseline, week 4, week 12
measure: Change from baseline health care service needs at week 4 and week 12
timeFrame: baseline, week 4, week 12
measure: Change from baseline working capability at week 4 and week 12
timeFrame: baseline, week 4, week 12
measure: Change from baseline sleep quality at week 4 and week 12
timeFrame: baseline, week 4, week 12
measure: Change from baseline sleep quality at week 4 and week 12
timeFrame: baseline, week 4, week 12
measure: Change from baseline Depression status assessed by Patient Health Questionnaire 9
timeFrame: baseline, week 4, week 12
measure: Change from baseline Anxiety status assessed by Generalized Anxiety Disorder Scale 7
timeFrame: baseline, week 4, week 12
measure: Change from baseline resilience assessed by resilience scale 13
timeFrame: baseline, week 4, week 12
measure: Change from baseline cognitive status assessed by Montreal Cognitive Assessment Test
timeFrame: baseline, week 4, week 12
measure: Change from baseline dyspnea assessed by Modified Medical Research Counsil score at week 4 and week 12
timeFrame: baseline, week 4, week 12
measure: Change from baseline dysfunctional breathing assessed by Nijmegen breathing questionnaire at week 4 and week 12
timeFrame: baseline, week 4, week 12
measure: Change from baseline chronic fatigue syndrome assessed by fatigue assessment scale at week 4 and week 12
timeFrame: baseline, week 4, week 12
measure: Change from baseline chronic fatigue syndrome assessed by canadian consensus criteria at week 12
timeFrame: baseline, week 12
measure: Change from baseline functional status assessed by post-COVID functional status scale at week 4 and week 12
timeFrame: baseline, week 4, week 12
measure: Change from baseline physical activity assessed by Garmin watch at week 4 and week 12
timeFrame: baseline, week 4, week 12
measure: Change from baseline blood pressure assessed at week 4 and week 12
timeFrame: baseline, week 4, week 12
measure: Change from baseline oxygen saturation assessed by pulse oximeter at week 4 and week 12
timeFrame: baseline, week 4, week 12
measure: Change from baseline peak flow assessed by peak flow meter at week 4 and week 12
timeFrame: baseline, week 4, week 12
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: University Hospital Augsburg
city: Bad Reichenhall
country: Germany
facility: Praxis Dr. Schrag
city: Berlin
country: Germany
facility: Pneumologen Lichterfelde Berlin
city: Erlangen
country: Germany
facility: Praxis im Zentrum Erlangen
city: Marburg
country: Germany
facility: Pneumopraxis Marburg
city: Munich
country: Germany
facility: Lungenärzte am Rundfunkplatz, München
city: Schwabach
country: Germany
facility: Praxis Dr. Roch
city: Schönau am Königssee
country: Germany
facility: COVID ambulance Prof. Koczulla
Study officials:
References: