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

NCT05172206 | Completed

• 1 other identifier: RELOAD
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 8

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.

Conditions

COVID-19; Long-COVID

Keywords

rehabilitation; intervention; quality of life; long-COVID; post-COVID syndrome; sequelae; recovery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (23)

• Change from baseline COVID-related symptoms at week 4 and week 12

  baseline, week 4, week 12

• Change from baseline lung function at week 4 and week 12

  baseline, week 4, week 12

• Change from baseline blood gas analysis at week 4 and week 12

  baseline, week 4, week 12

• Change from baseline Cardiac Doppler echocardiography at week 4 and week 12

  baseline, week 4, week 12

• Change from baseline laboratory parameters at week 4 and week 12

  baseline, week 4, week 12

Study Arms (2)

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.

Other: symptom-focused rehabilitation

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.

Other: usual care

Interventions

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.

Symptom-focused Rehabilitation

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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Post-COVID Syndrome according to World Health Organisation definition (persistent symptoms for at least 3 months after PCR-test confirmed SARS-CoV 2 infection)

You may not qualify if:

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

Sponsors & Collaborators

• Schön Klinik Berchtesgadener Land: lead
• Bavarian State Office for Health and Food Safety: collaborator
• Praxis im Zentrum Erlangen: collaborator
• Pneumologen Lichterfelde Berlin: collaborator
• Pneumopraxis Marburg: collaborator
• COVID ambulance Philipps-University Marburg: collaborator
• Pneumologie Elisenhof Munich: collaborator
• COVID ambulance Pneumology LMU Munich: collaborator
• COVID ambulance psychology LMU Munich: collaborator
• University Clinic Augsburg: collaborator
• COVID ambulance Schön Klinik Schönau: collaborator

Study Sites (8)

University Hospital Augsburg

Augsburg, Germany

Location

Praxis Dr. Schrag

Bad Reichenhall, Germany

Location

Pneumologen Lichterfelde Berlin

Berlin, Germany

Location

Praxis im Zentrum Erlangen

Erlangen, Germany

Location

Pneumopraxis Marburg

Marburg, Germany

Location

Lungenärzte am Rundfunkplatz, München

Munich, Germany

Location

COVID ambulance Prof. Koczulla

Schönau am Königssee, Germany

Location

Praxis Dr. Roch

Schwabach, Germany

Location

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: December 29, 2021
• Study Start: May 20, 2022
• Primary Completion: January 25, 2024
• Study Completion: January 25, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Locations

DE (8)