CClinicalTrials.gg
CompletedNCT06124625ReLoAd2Updated Aug 7, 2026

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

An interventional study of Rehabilitation combined to a digital maintenance program and Rehabilitation without maintenance program in Post-COVID-19 Syndrome, sponsored by Schön Klinik Berchtesgadener Land. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-07.

Sponsored by Schön Klinik Berchtesgadener Land · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Post-COVID-19 Syndrome

Keywords

  • rehabilitation
  • maintenance program
03

In context

Post-Acute COVID-19 Syndrome

520 studies on the registry are indexed under Post-Acute COVID-19 Syndrome; 186 are open to participants now.

This study's enrollment of 90 is above the median of 60 across 361 interventional studies indexed under Post-Acute COVID-19 Syndrome.

Browse Post-Acute COVID-19 Syndrome studies →

Lead sponsor

Schön Klinik Berchtesgadener Land is the lead sponsor of 51 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • No internet access
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    Rehabilitation maintenance program

    Procedure: Rehabilitation combined to a digital maintenance program

  • Placebo comparator
    No Rehabilitation maintenance program

    Procedure: Rehabilitation without maintenance program

Interventions

  • ProcedureRehabilitation 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.

  • ProcedureRehabilitation without maintenance program

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Baseline, week 4, week 19

Secondary outcomes

  1. 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 \[very severe symptom\].

    Time frame: Baseline, week 4, week 19

  2. Change from baseline lung function at week 4 and week 19

    following Parameters will be collected:Pimax

    Time frame: Baseline, week 4, week 19

  3. Change from baseline fatigue symptoms at week 4 and week 19

    Fatigue Assessment Scale will be used

    Time frame: Baseline, week 4, week 19

  4. 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)

    Time frame: Baseline, week 4, week 19

  5. Change from baseline physical activity at week 4 and week 19

    Activity will be measure in steps per day using a wearable from Polar

    Time frame: Baseline, week 4, week 19

  6. Change from baseline quality of life at week 4 and week 19

    EQ-5D-5L questionnaire will be used.

    Time frame: Baseline, week 4, week 19

  7. Change from the use of health care service at week 4 and week 19

    Frequency of therapeutical, medical and psychological sessions will be documented.

    Time frame: Baseline, week 4, week 19

  8. Change from the use of medications at week 4 and week 19

    Amount and kind of medication will be documented.

    Time frame: Baseline, week 4, week 19

  9. Change from rate of sickness at week 4 and week 19

    Days of sickness will be documented.

    Time frame: Baseline, week 4, week 19

  10. Change from workability at week 4 and week 19

    Work ability index will be used

    Time frame: Baseline, week 4, week 19

  11. Change from ICF functionality at week 4 and week 19

    Indicators of rehabilitation status questionnaire (IRES-3) will be used.

    Time frame: Baseline, week 4, week 19

  12. 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)

    Time frame: Baseline, week 4, week 19

  13. 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

    Time frame: Baseline, week 4, week 19

  14. 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

    Time frame: Baseline, week 4, week 19

  15. Change from resilience at week 4 and week 19

    Resilience scale RS-13 will be used.

    Time frame: Baseline, week 4, week 19

  16. Change from cognition at week 4 and week 19

    Cognition will be measured via the software RehaCom (by Hasomed GmbH).

    Time frame: Baseline, week 4, week 19

  17. Change from cognitive impairment at week 4 and week 19

    Cognitive impairment will be measured by Montreal Cognitive Assessment (MoCA)

    Time frame: Baseline, week 4, week 19

07

Study locations

1 site
  • Schone Klinik Berchtesgadener Land
    Schönau am Königssee, 83471, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06124625
Lead sponsor
Schön Klinik Berchtesgadener Land
Collaborators
Bavarian State Ministry of Health and Care (Funding), Deutsche Rentenversicherung (German pension insurance), Betriebskrankenkassen Landesverband Bayern (Bavarian health insurance) (Design)
Responsible party
Prof. Dr. Andreas Rembert Koczulla (Head of pulmonology, head of institute for pulmonary rehabilitation research, Schön Klinik Berchtesgadener Land) — Principal investigator
First posted
Nov 9, 2023
Start date
Jan 31, 2024
Primary completion
Sep 8, 2025
Completion
Sep 8, 2025
Last update
Aug 7, 2026

Study contacts

Andreas R Koczulla, PROF
principal investigator · Schön Klinik Berchtesgadener Land

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion