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

Schön Klinik Berchtesgadener Land

Status: Completed

Conditions: COVID-19; Long-COVID

Treatments: Other: usual care; Other: symptom-focused rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05172206

RELOAD

Details and patient eligibility

About

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.

Enrollment: 132 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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132 participants in 2 patient groups

Symptom-focused Rehabilitation

Active Comparator group

Description:

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.

Treatment:

Other: symptom-focused rehabilitation

Usual Care

Other group

Description:

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.

Treatment:

Other: usual care