Symptom-based Rehabilitation Compared to Usual Care in Post-COVID - a Randomized Controlled Trial

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.

Conditions

• COVID-19
• Long-COVID

Interventions

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.

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.

Sponsors & Collaborators

• Bavarian State Office for Health and Food Safety

  collaborator UNKNOWN

• Praxis im Zentrum Erlangen

  collaborator UNKNOWN

• Pneumologen Lichterfelde Berlin

  collaborator UNKNOWN

• Pneumopraxis Marburg

  collaborator UNKNOWN

• COVID ambulance Philipps-University Marburg

  collaborator UNKNOWN

• Pneumologie Elisenhof Munich

  collaborator UNKNOWN

• COVID ambulance Pneumology LMU Munich

  collaborator UNKNOWN

• COVID ambulance psychology LMU Munich

  collaborator UNKNOWN

• University Clinic Augsburg

  collaborator UNKNOWN

• COVID ambulance Schön Klinik Schönau

  collaborator UNKNOWN

• Schön Klinik Berchtesgadener Land

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-05-20

Primary Completion

2024-01-25

Completion

2024-01-25

Countries

• Germany

Study Locations