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

NCT ID: NCT06124625

Last Updated: 2025-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Post-COVID-19 Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Rehabilitation maintenance program

Group Type ACTIVE_COMPARATOR

Rehabilitation combined to a digital maintenance program

Intervention Type 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.

No Rehabilitation maintenance program

Group Type PLACEBO_COMPARATOR

Rehabilitation without maintenance program

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Rehabilitation without maintenance program

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* No internet access
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bavarian State Ministry of Health and Care (Funding)

UNKNOWN

Sponsor Role collaborator

Deutsche Rentenversicherung (German pension insurance)

UNKNOWN

Sponsor Role collaborator

Betriebskrankenkassen Landesverband Bayern (Bavarian health insurance) (Design)

UNKNOWN

Sponsor Role collaborator

Schön Klinik Berchtesgadener Land

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Andreas Rembert Koczulla

Head of pulmonology, head of institute for pulmonary rehabilitation research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas R Koczulla, PROF

Role: PRINCIPAL_INVESTIGATOR

Schön Klinik Berchtesgadener Land

Locations

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Schone Klinik Berchtesgadener Land

Schönau am Königssee, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Reload 2.0

Identifier Type: -

Identifier Source: org_study_id

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