Post-COVID-19 SyndromeReLoAd2NCT06124625
Effects of Rehabilitation Combined With a Maintenance Program Compared to Rehabilitation Alone in Post-COVID-19
A study testing Rehabilitation combined to a digital maintenance program and Rehabilitation without maintenance program in people with Post-COVID-19 Syndrome, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-COVID-19 Syndrome
- What is being tested?
- Rehabilitation combined to a digital maintenance program and Rehabilitation without maintenance program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- 31 Jan 2024to 8 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-COVID-syndrome (Definition WHO)
- Entered the rehabilitation process at the Schoen Klinik Berchtesgadener Land
Who cannot join
- No internet access
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Post-COVID-19 Syndrome
- Being tested
- Rehabilitation combined to a digital maintenance program, Rehabilitation without maintenance program
- Keywords
- rehabilitation, maintenance program
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation combined to a digital maintenance programProcedure or surgery
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 programProcedure or surgery
Individuals in this group undergo a 3-week inpatient rehabilitation program followed by a 12-week usual care period.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation maintenance program | Active comparator | Not described Receives: Procedure: Rehabilitation combined to a digital maintenance program |
| No Rehabilitation maintenance program | Placebo comparator | Not described Receives: Procedure: Rehabilitation without maintenance program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline quality of life assessed by Short-Form 12 questionnaire at week 4 and 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
Measured: Baseline, week 4, week 19
Secondary outcomes (17)
Change from baseline post-COVID-related symptoms at week 4 and 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].
Measured: Baseline, week 4, week 19
Change from baseline lung function at week 4 and week 19
following Parameters will be collected:Pimax
Measured: Baseline, week 4, week 19
Change from baseline fatigue symptoms at week 4 and week 19
Fatigue Assessment Scale will be used
Measured: Baseline, week 4, week 19
Change from baseline exercise capacity at week 4 and week 19
1-minute sit to stand test will be performed (maximum repetitions of squats in one minute)
Measured: Baseline, week 4, week 19
Change from baseline physical activity at week 4 and week 19
Activity will be measure in steps per day using a wearable from Polar
Measured: Baseline, week 4, week 19
Change from baseline quality of life at week 4 and week 19
EQ-5D-5L questionnaire will be used.
Measured: Baseline, week 4, week 19
Change from the use of health care service at week 4 and week 19
Frequency of therapeutical, medical and psychological sessions will be documented.
Measured: Baseline, week 4, week 19
Change from the use of medications at week 4 and week 19
Amount and kind of medication will be documented.
Measured: Baseline, week 4, week 19
Change from rate of sickness at week 4 and week 19
Days of sickness will be documented.
Measured: Baseline, week 4, week 19
Change from workability at week 4 and week 19
Work ability index will be used
Measured: Baseline, week 4, week 19
Change from ICF functionality at week 4 and week 19
Indicators of rehabilitation status questionnaire (IRES-3) will be used.
Measured: Baseline, week 4, week 19
Change from sleep quality at week 4 and 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)
Measured: Baseline, week 4, week 19
Change from depression symptoms at week 4 and 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
Measured: Baseline, week 4, week 19
Change from anxiety symptoms at week 4 and 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
Measured: Baseline, week 4, week 19
Change from resilience at week 4 and week 19
Resilience scale RS-13 will be used.
Measured: Baseline, week 4, week 19
Change from cognition at week 4 and week 19
Cognition will be measured via the software RehaCom (by Hasomed GmbH).
Measured: Baseline, week 4, week 19
Change from cognitive impairment at week 4 and week 19
Cognitive impairment will be measured by Montreal Cognitive Assessment (MoCA)
Measured: Baseline, week 4, week 19
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start31 Jan 2024
- Primary completion8 Sep 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Collaborators
- Bavarian State Ministry of Health and Care (Funding), Deutsche Rentenversicherung (German pension insurance), Betriebskrankenkassen Landesverband Bayern (Bavarian health insurance) (Design)
- Responsible party
- Principal investigator, Prof. Dr. Andreas Rembert Koczulla, Schön Klinik Berchtesgadener Land
- Investigators
- Andreas R Koczulla, PROF, Principal investigator, Schön Klinik Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124625
- Sponsor's protocol ID
- Reload 2.0
- Acronym
- ReLoAd2
- Status last verified
- May 2026
- First submitted
- 8 Nov 2023
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rehabilitation Combined With a 12-week Maintenance Program Compared to Rehabilitation Alone in Post-COVID-19 - a Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT06124625
- Acronym / sponsor ID
- ReLoAd2 / Reload 2.0
- Conditions
- Post-COVID-19 Syndrome
- Keywords
- rehabilitation, maintenance program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Collaborators
- Bavarian State Ministry of Health and Care (Funding), Deutsche Rentenversicherung (German pension insurance), Betriebskrankenkassen Landesverband Bayern (Bavarian health insurance) (Design)
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation maintenance program | Active comparator | Procedure: Rehabilitation combined to a digital maintenance program |
| No Rehabilitation maintenance program | Placebo comparator | Procedure: Rehabilitation without maintenance program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Post-COVID-syndrome (Definition WHO)
- Entered the rehabilitation process at the Schoen Klinik Berchtesgadener Land
Key exclusion criteria (1 listed)
- No internet access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rehabilitation combined to a digital maintenance programIndividuals 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. | Procedure or surgery | Rehabilitation maintenance program |
| Rehabilitation without maintenance programIndividuals in this group undergo a 3-week inpatient rehabilitation program followed by a 12-week usual care period. | Procedure or surgery | No Rehabilitation maintenance program |
Primary outcome
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
17 secondary outcomes
Change from baseline post-COVID-related symptoms at week 4 and week 19
Time frame: Baseline, week 4, week 19
Change from baseline lung function at week 4 and week 19
Time frame: Baseline, week 4, week 19
Change from baseline fatigue symptoms at week 4 and week 19
Time frame: Baseline, week 4, week 19
Change from baseline exercise capacity at week 4 and week 19
Time frame: Baseline, week 4, week 19
Change from baseline physical activity at week 4 and week 19
Time frame: Baseline, week 4, week 19
Change from baseline quality of life at week 4 and week 19
Time frame: 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
Change from the use of medications at week 4 and week 19
Time frame: Baseline, week 4, week 19
Change from rate of sickness at week 4 and week 19
Time frame: Baseline, week 4, week 19
Change from workability at week 4 and week 19
Time frame: Baseline, week 4, week 19
Change from ICF functionality at week 4 and week 19
Time frame: Baseline, week 4, week 19
Change from sleep quality at week 4 and week 19
Time frame: Baseline, week 4, week 19
Change from depression symptoms at week 4 and week 19
Time frame: Baseline, week 4, week 19
Change from anxiety symptoms at week 4 and week 19
Time frame: Baseline, week 4, week 19
Change from resilience at week 4 and week 19
Time frame: Baseline, week 4, week 19
Change from cognition at week 4 and week 19
Time frame: Baseline, week 4, week 19
Change from cognitive impairment at week 4 and week 19
Time frame: Baseline, week 4, week 19
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
Related trials for Post-COVID-19 Syndrome
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Not yet recruitingPhase 3
The Study of Brave-LC LDN Treatment Trial
Post-acute COVID-19 Syndrome
Active, not recruitingObservational study
Epigenetic Changes in Long COVID Patients
Long COVID-19 Syndrome, Long COVID Symptoms
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas R Koczulla, PROF principal investigator
Schön Klinik Berchtesgadener Land
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation combined to a digital maintenance program and Rehabilitation without maintenance program in people with Post-COVID-19 Syndrome, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.