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NCT Number: NCT05172206

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

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.

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Key information

Conditions

COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Long-COVID Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Augsburg, Augsburg, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change from baseline Quality of life assessed by Short Form - 12 Questionnaire at week 4 and week 12

    Time frame: 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 outcomes

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

    Time frame: 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].

  2. Change from baseline lung function at week 4 and week 12

    Time frame: 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

  3. Change from baseline blood gas analysis at week 4 and week 12

    Time frame: 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

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

    Time frame: baseline, week 4, week 12

    Left and right heart echocardiography will be performed

  5. Change from baseline laboratory parameters at week 4 and week 12

    Time frame: baseline, week 4, week 12

    blood samples will be taken from venous blood

  6. Change from baseline exercise performance at week 4 and week 12

    Time frame: baseline, week 4, week 12

    incremental cardiopulmonary exercise testing will be performed with spirometry

  7. Change from baseline health care service needs at week 4 and week 12

    Time frame: 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

  8. Change from baseline working capability at week 4 and week 12

    Time frame: baseline, week 4, week 12

    number of days of incapacity to work until the last visit will be recorded

  9. Change from baseline sleep quality at week 4 and week 12

    Time frame: 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)

  10. Change from baseline sleep quality at week 4 and week 12

    Time frame: 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)

  11. Change from baseline Depression status assessed by Patient Health Questionnaire 9

    Time frame: baseline, week 4, week 12

    the total score ranges from 0 to 27 points with higher scores indicating worse Depression symptoms

  12. Change from baseline Anxiety status assessed by Generalized Anxiety Disorder Scale 7

    Time frame: baseline, week 4, week 12

    the total score ranges from 0 to 21 points with higher scores indicating more anxiety symptoms

  13. Change from baseline resilience assessed by resilience scale 13

    Time frame: baseline, week 4, week 12

    the total score ranges from 13 to 91 points with higher scores indicating higher resilience

  14. Change from baseline cognitive status assessed by Montreal Cognitive Assessment Test

    Time frame: baseline, week 4, week 12

    the total score ranges from 0 to 30 points with higher scores indicating a better cognitive status

  15. Change from baseline dyspnea assessed by Modified Medical Research Counsil score at week 4 and week 12

    Time frame: baseline, week 4, week 12

    the total score ranges from 0 to 4 points with higher scores indicating more dyspnea

  16. Change from baseline dysfunctional breathing assessed by Nijmegen breathing questionnaire at week 4 and week 12

    Time frame: baseline, week 4, week 12

    the total score ranges from 0 to 64 points with higher scores indicating hyperventilation

  17. Change from baseline chronic fatigue syndrome assessed by fatigue assessment scale at week 4 and week 12

    Time frame: baseline, week 4, week 12

    the total score ranges from 10 to 50 points with higher scores indicating more fatigue

  18. Change from baseline chronic fatigue syndrome assessed by canadian consensus criteria at week 12

    Time frame: baseline, week 12

    the canadian consensus criteria indicate if patients developed a chronic fatigue syndrome/myalgic encephalomyelitis

  19. Change from baseline functional status assessed by post-COVID functional status scale at week 4 and week 12

    Time frame: baseline, week 4, week 12

    the total score ranges from 0 to 4 points with higher scores indicating more impairment

  20. Change from baseline physical activity assessed by Garmin watch at week 4 and week 12

    Time frame: baseline, week 4, week 12

    daily total steps per day will be recorded by a Garmin watch linked to the SaniQ App

  21. Change from baseline blood pressure assessed at week 4 and week 12

    Time frame: baseline, week 4, week 12

    blood pressure will be measured at the upper arm using the Aponorm device

  22. Change from baseline oxygen saturation assessed by pulse oximeter at week 4 and week 12

    Time frame: baseline, week 4, week 12

    Beurer pulse oximeter

  23. Change from baseline peak flow assessed by peak flow meter at week 4 and week 12

    Time frame: baseline, week 4, week 12

    peak flow will be assessed by smart one spirometer

Sponsors and collaborators

Lead sponsor

Schön Klinik Berchtesgadener Land

Other

Collaborators

  • Bavarian State Office for Health and Food Safety
  • COVID ambulance Philipps-University Marburg
  • COVID ambulance Schön Klinik Schönau
  • Ludwig-Maximilians - University of Munich
  • Pneumologen Lichterfelde Berlin
  • Pneumologie Elisenhof Munich
  • Pneumopraxis Marburg
  • Praxis im Zentrum Erlangen
  • University Clinic Augsburg

Registry information

Acronym: RELOAD

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 29, 2021
Registry last updated
Mar 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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