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

August 4, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Schön Klinik Berchtesgadener Land

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bavarian State Ministry of Health and Care (Funding)
Betriebskrankenkassen Landesverband Bayern (Bavarian health insurance) (Design)
Deutsche Rentenversicherung (German pension insurance)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 8, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 8, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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