COVID-19RELOADNCT05172206
Symptom-based Rehabilitation Compared to Usual Care in Post-COVID - a Randomized Controlled Trial
A study testing symptom-focused rehabilitation in people with COVID-19 and Long-COVID, run by Schön Klinik Berchtesgadener Land at 8 sites in Germany.
Trial summary
Inpatient, multimodal rehabilitation represents one of the most important interventions in the disease management of post/long COVID. Different professional societies, including the German Society of Pneumology and the European Respiratory Society, recommend rehabilitation intervention to reduce the sequelae of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Long-COVID
- What is being tested?
- symptom-focused rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 8 sitesGermany
- Study dates
- 20 May 2022to 25 Jan 2024
- 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 according to World Health Organisation definition (persistent symptoms for at least 3 months after PCR-test confirmed SARS-CoV 2 infection)
Who cannot join
- no walking ability
- not able to operate smartphone apps
- rehabilitation program within the previous 6 months
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
University Hospital Augsburg
Augsburg
Praxis Dr. Schrag
Bad Reichenhall
Pneumologen Lichterfelde Berlin
Berlin
Praxis im Zentrum Erlangen
Erlangen
Pneumopraxis Marburg
Marburg
Lungenärzte am Rundfunkplatz, München
Munich
COVID ambulance Prof. Koczulla
Schönau am Königssee
Praxis Dr. Roch
Schwabach
About this study
Inpatient, multimodal rehabilitation represents one of the most important interventions in the disease management of post/long COVID. Different professional societies, including the German Society of Pneumology and the European Respiratory Society, recommend rehabilitation intervention to reduce the sequelae of COVID-19. However, from the perspective of science and practice, there are relevant areas that have been insufficiently investigated and are essential for the treatment success of post/long COVID patients:
- Differentiation of rehabilitation effects from natural recovery after COVID-19.
- Lack of personalized and symptom-based treatment approaches that can address the heterogeneity of symptoms in post/long COVID
- Lack of uniform, high-quality rehabilitation standards in post-/long-COVID.
Therefore, post-COVID patients will be recruited at several post-COVID practices around Germany and randomized to receive (A) a rehabilitation program or (B) usual care. The primary objective of this randomized controlled trial (RCT) is to investigate whether a 3-week symptom-oriented, inpatient, multidisciplinary rehabilitation intervention, whose content focus is standardized according to cluster assignment (fatigue, cognition, soma), has a positive effect on the quality of life (primary outcome) in post-COVID syndrome patients compared to a usual care group (standard outpatient care). All study participants will be provided with a continuous telemonitoring system (SaniQ app) throughout the study period. After the interventional phase, there will be a 3 months follow-up assessment to evaluate the maintenance effects of COVID rehabilitation.
- Conditions
- COVID-19, Long-COVID
- Being tested
- symptom-focused rehabilitation, usual care
- Keywords
- rehabilitation, intervention, quality of life, long-COVID, post-COVID syndrome, sequelae, recovery
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
symptom-focused rehabilitationOther
Patients in this arm will be referred to a 3-week inpatient comprehensive rehabilitation program. Initially, patients will be classified into one out of three clusters namely: Cluster A (Fatigue), Cluster B (cognition), or Cluster C (physical). The content of the rehabilitation program will be individually adapted according to the patient's most relevant symptom cluster.
usual careOther
Patients in this arm do not receive any intervention beyond usual care during the study phase. However, all patients in this group will get the opportunity to also receive a rehabilitation program after the study phase.
| Study group | Role | What they receive |
|---|---|---|
| Symptom-focused Rehabilitation | Active comparator | Patients in this arm will be referred to a 3-week inpatient comprehensive rehabilitation program. Initially, patients will be classified into one out of three clusters namely: Cluster A (Fatigue), Cluster B (cognition), or Cluster C (physical). The content of the rehabilitation program will be individually adapted according to the patient's most relevant symptom cluster. Receives: Other: symptom-focused rehabilitation |
| Usual Care | Other | Patients in this arm do not receive any intervention beyond usual care during the study phase. However, all patients in this group will get the opportunity to also receive a rehabilitation program after the study phase. Receives: Other: usual care |
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 12
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 12
Secondary outcomes (23)
Change from baseline COVID-related symptoms at week 4 and week 12
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 12
Change from baseline lung function at week 4 and week 12
following Parameters will be collected: forced expiratory volume in 1 sec, peak flow, forced vital capacity, total lung capacity, diffusion lung capacity for carbonmonoxide
Measured: baseline, week 4, week 12
Change from baseline blood gas analysis at week 4 and week 12
following parameters will be collected at rest and at the end of an incremental cycle test: partial pressure for oxygen and carbon dioxide
Measured: baseline, week 4, week 12
Change from baseline Cardiac Doppler echocardiography at week 4 and week 12
Left and right heart echocardiography will be performed
Measured: baseline, week 4, week 12
Change from baseline laboratory parameters at week 4 and week 12
blood samples will be taken from venous blood
Measured: baseline, week 4, week 12
Change from baseline exercise performance at week 4 and week 12
incremental cardiopulmonary exercise testing will be performed with spirometry
Measured: baseline, week 4, week 12
Change from baseline health care service needs at week 4 and week 12
Number of visits at the general practitioner, pulmonologist, psychologist, physiotherapist, COVID-ambulance, hospital admission until the last visit will be recorded
Measured: baseline, week 4, week 12
Change from baseline working capability at week 4 and week 12
number of days of incapacity to work until the last visit will be recorded
Measured: baseline, week 4, week 12
Change from baseline sleep quality at week 4 and week 12
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 12
Change from baseline sleep quality at week 4 and week 12
daytime sleepiness will be assessed by using the Epworth Sleepiness Scale (total score ranges from 0 to 24 with higher scores indicating higher impairment)
Measured: baseline, week 4, week 12
Change from baseline Depression status assessed by Patient Health Questionnaire 9
the total score ranges from 0 to 27 points with higher scores indicating worse Depression symptoms
Measured: baseline, week 4, week 12
Change from baseline Anxiety status assessed by Generalized Anxiety Disorder Scale 7
the total score ranges from 0 to 21 points with higher scores indicating more anxiety symptoms
Measured: baseline, week 4, week 12
Change from baseline resilience assessed by resilience scale 13
the total score ranges from 13 to 91 points with higher scores indicating higher resilience
Measured: baseline, week 4, week 12
Change from baseline cognitive status assessed by Montreal Cognitive Assessment Test
the total score ranges from 0 to 30 points with higher scores indicating a better cognitive status
Measured: baseline, week 4, week 12
Change from baseline dyspnea assessed by Modified Medical Research Counsil score at week 4 and week 12
the total score ranges from 0 to 4 points with higher scores indicating more dyspnea
Measured: baseline, week 4, week 12
Change from baseline dysfunctional breathing assessed by Nijmegen breathing questionnaire at week 4 and week 12
the total score ranges from 0 to 64 points with higher scores indicating hyperventilation
Measured: baseline, week 4, week 12
Change from baseline chronic fatigue syndrome assessed by fatigue assessment scale at week 4 and week 12
the total score ranges from 10 to 50 points with higher scores indicating more fatigue
Measured: baseline, week 4, week 12
Change from baseline chronic fatigue syndrome assessed by canadian consensus criteria at week 12
the canadian consensus criteria indicate if patients developed a chronic fatigue syndrome/myalgic encephalomyelitis
Measured: baseline, week 12
Change from baseline functional status assessed by post-COVID functional status scale at week 4 and week 12
the total score ranges from 0 to 4 points with higher scores indicating more impairment
Measured: baseline, week 4, week 12
Change from baseline physical activity assessed by Garmin watch at week 4 and week 12
daily total steps per day will be recorded by a Garmin watch linked to the SaniQ App
Measured: baseline, week 4, week 12
Change from baseline blood pressure assessed at week 4 and week 12
blood pressure will be measured at the upper arm using the Aponorm device
Measured: baseline, week 4, week 12
Change from baseline oxygen saturation assessed by pulse oximeter at week 4 and week 12
Beurer pulse oximeter
Measured: baseline, week 4, week 12
Change from baseline peak flow assessed by peak flow meter at week 4 and week 12
peak flow will be assessed by smart one spirometer
Measured: baseline, week 4, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start20 May 2022
- Primary completion25 Jan 2024
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Collaborators
- Bavarian State Office for Health and Food Safety, Praxis im Zentrum Erlangen, Pneumologen Lichterfelde Berlin, Pneumopraxis Marburg, Philipps University Marburg, Pneumologie Elisenhof Munich, Ludwig-Maximilians - University of Munich, University Clinic Augsburg, COVID ambulance Schön Klinik Schönau
- Responsible party
- Principal investigator, Prof. Dr. Andreas Rembert Koczulla, Schön Klinik Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172206
- Sponsor's protocol ID
- RELOAD
- Acronym
- RELOAD
- Status last verified
- Mar 2025
- First submitted
- 22 Dec 2021
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schneeberger T, Jarosch I, Kroll D, Gloeckl R, Schneider C, Ulm B, Schwaiblmair M, Lampert S, Greulich T, Schoenherr I, Schultz T, Schrag T, Dennis CJ, Koczulla AR. Symptom-based rehabilitation in people with post-COVID-19 condition (RELOAD study): a randomised controlled trial. BMJ Open Respir Res. 2026 May 20;13(1):e004177. doi: 10.1136/bmjresp-2026-004177.
PubMed 42161418
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptom-based Rehabilitation Compared to Usual Care in Post-COVID - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05172206
- Acronym / sponsor ID
- RELOAD / RELOAD
- Conditions
- COVID-19, Long-COVID
- Keywords
- rehabilitation, intervention, quality of life, long-COVID, post-COVID syndrome, sequelae, recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Collaborators
- Bavarian State Office for Health and Food Safety, Praxis im Zentrum Erlangen, Pneumologen Lichterfelde Berlin, Pneumopraxis Marburg, Philipps University Marburg, Pneumologie Elisenhof Munich, Ludwig-Maximilians - University of Munich, University Clinic Augsburg, COVID ambulance Schön Klinik Schönau
- Study start
- 20 May 2022 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 29 Dec 2021 (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.
Inpatient, multimodal rehabilitation represents one of the most important interventions in the disease management of post/long COVID. Different professional societies, including the German Society of Pneumology and the European Respiratory Society, recommend rehabilitation intervention to reduce the sequelae of COVID-19. However, from the perspective of science and practice, there are relevant areas that have been insufficiently investigated and are essential for the treatment success of post/long COVID patients:
- Differentiation of rehabilitation effects from natural recovery after COVID-19.
- Lack of personalized and symptom-based treatment approaches that can address the heterogeneity of symptoms in post/long COVID
- Lack of uniform, high-quality rehabilitation standards in post-/long-COVID.
Therefore, post-COVID patients will be recruited at several post-COVID practices around Germany and randomized to receive (A) a rehabilitation program or (B) usual care. The primary objective of this randomized controlled trial (RCT) is to investigate whether a 3-week symptom-oriented, inpatient, multidisciplinary rehabilitation intervention, whose content focus is standardized according to cluster assignment (fatigue, cognition, soma), has a positive effect on the quality of life (primary outcome) in post-COVID syndrome patients compared to a usual care group (standard outpatient care). All study participants will be provided with a continuous telemonitoring system (SaniQ app) throughout the study period. After the interventional phase, there will be a 3 months follow-up assessment to evaluate the maintenance effects of COVID rehabilitation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptom-focused Rehabilitation | Active comparator | Other: symptom-focused rehabilitationPatients in this arm will be referred to a 3-week inpatient comprehensive rehabilitation program. Initially, patients will be classified into one out of three clusters namely: Cluster A (Fatigue), Cluster B (cognition), or Cluster C (physical). The content of the rehabilitation program will be individually adapted according to the patient's most relevant symptom cluster. |
| Usual Care | Other | Other: usual carePatients in this arm do not receive any intervention beyond usual care during the study phase. However, all patients in this group will get the opportunity to also receive a rehabilitation program after the study phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Post-COVID Syndrome according to World Health Organisation definition (persistent symptoms for at least 3 months after PCR-test confirmed SARS-CoV 2 infection)
Key exclusion criteria (3 listed)
- no walking ability
- not able to operate smartphone apps
- rehabilitation program within the previous 6 months
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 |
|---|---|---|
| symptom-focused rehabilitationPatients in this arm will be referred to a 3-week inpatient comprehensive rehabilitation program. Initially, patients will be classified into one out of three clusters namely: Cluster A (Fatigue), Cluster B (cognition), or Cluster C (physical). The content of the rehabilitation program will be individually adapted according to the patient's most relevant symptom cluster. | Other | Symptom-focused Rehabilitation |
| usual carePatients in this arm do not receive any intervention beyond usual care during the study phase. However, all patients in this group will get the opportunity to also receive a rehabilitation program after the study phase. | Other | Usual Care |
Primary outcome
Change from baseline Quality of life assessed by Short Form - 12 Questionnaire at week 4 and week 12
Time frame: baseline, week 4, week 12
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
23 secondary outcomes
Change from baseline COVID-related symptoms at week 4 and week 12
Time frame: baseline, week 4, week 12
Change from baseline lung function at week 4 and week 12
Time frame: baseline, week 4, week 12
Change from baseline blood gas analysis at week 4 and week 12
Time frame: baseline, week 4, week 12
Change from baseline Cardiac Doppler echocardiography at week 4 and week 12
Time frame: baseline, week 4, week 12
Change from baseline laboratory parameters at week 4 and week 12
Time frame: baseline, week 4, week 12
Change from baseline exercise performance at week 4 and week 12
Time frame: baseline, week 4, week 12
Change from baseline health care service needs at week 4 and week 12
Time frame: baseline, week 4, week 12
Change from baseline working capability at week 4 and week 12
Time frame: baseline, week 4, week 12
Change from baseline sleep quality at week 4 and week 12
Time frame: baseline, week 4, week 12
Change from baseline sleep quality at week 4 and week 12
Time frame: baseline, week 4, week 12
Change from baseline Depression status assessed by Patient Health Questionnaire 9
Time frame: baseline, week 4, week 12
Change from baseline Anxiety status assessed by Generalized Anxiety Disorder Scale 7
Time frame: baseline, week 4, week 12
Change from baseline resilience assessed by resilience scale 13
Time frame: baseline, week 4, week 12
Change from baseline cognitive status assessed by Montreal Cognitive Assessment Test
Time frame: baseline, week 4, week 12
Change from baseline dyspnea assessed by Modified Medical Research Counsil score at week 4 and week 12
Time frame: baseline, week 4, week 12
Change from baseline dysfunctional breathing assessed by Nijmegen breathing questionnaire at week 4 and week 12
Time frame: baseline, week 4, week 12
Change from baseline chronic fatigue syndrome assessed by fatigue assessment scale at week 4 and week 12
Time frame: baseline, week 4, week 12
Change from baseline chronic fatigue syndrome assessed by canadian consensus criteria at week 12
Time frame: baseline, week 12
Change from baseline functional status assessed by post-COVID functional status scale at week 4 and week 12
Time frame: baseline, week 4, week 12
Change from baseline physical activity assessed by Garmin watch at week 4 and week 12
Time frame: baseline, week 4, week 12
Change from baseline blood pressure assessed at week 4 and week 12
Time frame: baseline, week 4, week 12
Change from baseline oxygen saturation assessed by pulse oximeter at week 4 and week 12
Time frame: baseline, week 4, week 12
Change from baseline peak flow assessed by peak flow meter at week 4 and week 12
Time frame: baseline, week 4, week 12
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 28 Mar 2025.
- Derived from this study: PubMed 42161418Schneeberger T, Jarosch I, Kroll D, Gloeckl R, Schneider C, Ulm B, Schwaiblmair M, Lampert S, Greulich T, Schoenherr I, Schultz T, Schrag T, Dennis CJ, Koczulla AR. Symptom-based rehabilitation in people with post-COVID-19 condition (RELOAD study): a randomised controlled trial. BMJ Open Respir Res. 2026 May 20;13(1):e004177. doi: 10.1136/bmjresp-2026-004177.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing symptom-focused rehabilitation in people with COVID-19 and Long-COVID, run by Schön Klinik Berchtesgadener Land at 8 sites 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 1 inclusion and 3 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 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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. 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 12 (time frame: baseline, week 4, week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05172206, which also lists 1 linked publication.
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 28 Mar 2025.