Effects of Rehabilitation Combined With a Maintenance Program Compared to Rehabilitation Alone in Post-COVID-19 (ReLoAd2)

August 13, 2025 updated by: Prof. Dr. Andreas Rembert Koczulla, Schön Klinik Berchtesgadener Land

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Schönau Am Königssee, Germany, 83471
        • Schone Klinik Berchtesgadener Land

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • No internet access

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rehabilitation maintenance program
Procedure: Rehabilitation combined to a digital maintenance program
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.
Placebo Comparator: No Rehabilitation maintenance program
Procedure: Rehabilitation without maintenance program
Individuals in this group undergo a 3-week inpatient rehabilitation program followed by a 12-week usual care period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, week 4, week 19

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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].
Baseline, week 4, week 19
Change from baseline lung function at week 4 and week 19
Time Frame: Baseline, week 4, week 19
following Parameters will be collected:Pimax
Baseline, week 4, week 19
Change from baseline fatigue symptoms at week 4 and week 19
Time Frame: Baseline, week 4, week 19
Fatigue Assessment Scale will be used
Baseline, week 4, week 19
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)
Baseline, week 4, week 19
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
Baseline, week 4, week 19
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.
Baseline, week 4, week 19
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.
Baseline, week 4, week 19
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.
Baseline, week 4, week 19
Change from rate of sickness at week 4 and week 19
Time Frame: Baseline, week 4, week 19
Days of sickness will be documented.
Baseline, week 4, week 19
Change from workability at week 4 and week 19
Time Frame: Baseline, week 4, week 19
Work ability index will be used
Baseline, week 4, week 19
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.
Baseline, week 4, week 19
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)
Baseline, week 4, week 19
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
Baseline, week 4, week 19
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
Baseline, week 4, week 19
Change from resilience at week 4 and week 19
Time Frame: Baseline, week 4, week 19
Resilience scale RS-13 will be used.
Baseline, week 4, week 19
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).
Baseline, week 4, week 19
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)
Baseline, week 4, week 19

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Schön Klinik Berchtesgadener Land

Collaborators

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

Investigators

  • Principal Investigator: Andreas R Koczulla, PROF, Schön Klinik Berchtesgadener Land

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

November 8, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Actual)

November 9, 2023

Study Record Updates

Last Update Posted (Actual)

August 17, 2025

Last Update Submitted That Met QC Criteria

August 13, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Reload 2.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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