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NCT Number: NCT06124625

Effects of Rehabilitation Combined With a Maintenance Program Compared to Rehabilitation Alone in Post-COVID-19

Infection with SARS-CoV-2 virus leads to persistent symptoms for more than 12 weeks in 15% of cases ("post-COVID syndrome"). Symptoms like fatigue, dyspnoea, limitations in physical performance and activities, head ache, anxiety symptoms, and depression are heterogenous which limit physical health and participation in daily life activities.

In the last years, multidisciplinary rehabilitation programs showed benefits in quality of life and symptom intensity in patients with post-COVID. Therefore, rehabilitation programs are recommended for individuals with Post-COVID by official sites like the German Society of Pulmonology and the European Respiratory Society.

Own first data (published at the ERS conference 2023) revealed that one the one hand, inpatient rehabilitation is effective, however, on the other hand, it is challenging to maintain these effects after completing the program. Therefore, the aim of this study is to sustain these benefits by using a digital maintenance program following the rehabilitation program compared to usual care.

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Key information

Conditions

Post-COVID-19 Syndrome COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections 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

Schone Klinik Berchtesgadener Land

Schönau am Königssee, 83471, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Post-COVID-syndrome (Definition WHO)
  • Entered the rehabilitation process at the Schoen Klinik Berchtesgadener Land

Exclusion criteria

  • No internet access

Treatment and study plan

Rehabilitation combined to a digital maintenance program

Procedure

Individuals in this group undergo a 3-week inpatient rehabilitation program followed by a 12-week maintenance program (2 sessions per week à 90 minutes, digital and live). The multimodal programs consist of physiotherapy, training therapy, medical support, cognitive training, education and psychological support.

Rehabilitation without maintenance program

Procedure

Individuals in this group undergo a 3-week inpatient rehabilitation program followed by a 12-week usual care period.

Primary outcomes

  1. Change from baseline quality of life assessed by Short-Form 12 questionnaire at week 4 and week 19

    Time frame: Baseline, week 4, week 19

    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 post-COVID-related symptoms at week 4 and week 19

    Time frame: Baseline, week 4, week 19

    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 19

    Time frame: Baseline, week 4, week 19

    following Parameters will be collected:Pimax

  3. Change from baseline fatigue symptoms at week 4 and week 19

    Time frame: Baseline, week 4, week 19

    Fatigue Assessment Scale will be used

  4. Change from baseline exercise capacity at week 4 and week 19

    Time frame: Baseline, week 4, week 19

    1-minute sit to stand test will be performed (maximum repetitions of squats in one minute)

  5. Change from baseline physical activity at week 4 and week 19

    Time frame: Baseline, week 4, week 19

    Activity will be measure in steps per day using a wearable from Polar

  6. Change from baseline quality of life at week 4 and week 19

    Time frame: Baseline, week 4, week 19

    EQ-5D-5L questionnaire will be used.

  7. Change from the use of health care service at week 4 and week 19

    Time frame: Baseline, week 4, week 19

    Frequency of therapeutical, medical and psychological sessions will be documented.

  8. Change from the use of medications at week 4 and week 19

    Time frame: Baseline, week 4, week 19

    Amount and kind of medication will be documented.

  9. Change from rate of sickness at week 4 and week 19

    Time frame: Baseline, week 4, week 19

    Days of sickness will be documented.

  10. Change from workability at week 4 and week 19

    Time frame: Baseline, week 4, week 19

    Work ability index will be used

  11. Change from ICF functionality at week 4 and week 19

    Time frame: Baseline, week 4, week 19

    Indicators of rehabilitation status questionnaire (IRES-3) will be used.

  12. Change from sleep quality at week 4 and week 19

    Time frame: Baseline, week 4, week 19

    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)

  13. Change from depression symptoms at week 4 and week 19

    Time frame: Baseline, week 4, week 19

    Patient Health Questionnaire 9 will be used. The total score ranges from 0 to 27 points with higher scores indicating worse Depression symptoms

  14. Change from anxiety symptoms at week 4 and week 19

    Time frame: Baseline, week 4, week 19

    Generalized Anxiety Disorder Scale 7 will be used. The total score ranges from 0 to 21 points with higher scores indicating more anxiety symptoms

  15. Change from resilience at week 4 and week 19

    Time frame: Baseline, week 4, week 19

    Resilience scale RS-13 will be used.

  16. Change from cognition at week 4 and week 19

    Time frame: Baseline, week 4, week 19

    Cognition will be measured via the software RehaCom (by Hasomed GmbH).

  17. Change from cognitive impairment at week 4 and week 19

    Time frame: Baseline, week 4, week 19

    Cognitive impairment will be measured by Montreal Cognitive Assessment (MoCA)

Sponsors and collaborators

Lead sponsor

Schön Klinik Berchtesgadener Land

Other

Collaborators

  • Bavarian State Ministry of Health and Care (Funding)
  • Betriebskrankenkassen Landesverband Bayern (Bavarian health insurance) (Design)
  • Deutsche Rentenversicherung (German pension insurance)

Registry information

Official study title

Effects of Rehabilitation Combined With a 12-week Maintenance Program Compared to Rehabilitation Alone in Post-COVID-19 - a Randomized, Controlled Trial.

Acronym: ReLoAd2

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 9, 2023
Registry last updated
Aug 17, 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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