Clinical trial NCT06124625: Effects of Rehabilitation Combined With a Maintenance Program Compared to Rehabilitation Alone in Post-COVID-19
Official title: Effects of Rehabilitation Combined With a 12-week Maintenance Program Compared to Rehabilitation Alone in Post-COVID-19 - a Randomized, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post-COVID-19 Syndrome
Keywords: rehabilitation
maintenance program
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
Collaborators: name: Bavarian State Ministry of Health and Care (Funding)
name: Deutsche Rentenversicherung (German pension insurance)
name: Betriebskrankenkassen Landesverband Bayern (Bavarian health insurance) (Design)
First posted: 2023-11-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* No internet access

Primary outcomes:
measure: Change from baseline quality of life assessed by Short-Form 12 questionnaire at week 4 and week 19
timeFrame: Baseline, week 4, week 19
Secondary outcomes:
measure: Change from baseline post-COVID-related symptoms at week 4 and week 19
timeFrame: Baseline, week 4, week 19
measure: Change from baseline lung function at week 4 and week 19
timeFrame: Baseline, week 4, week 19
measure: Change from baseline fatigue symptoms at week 4 and week 19
timeFrame: Baseline, week 4, week 19
measure: Change from baseline exercise capacity at week 4 and week 19
timeFrame: Baseline, week 4, week 19
measure: Change from baseline physical activity at week 4 and week 19
timeFrame: Baseline, week 4, week 19
measure: Change from baseline quality of life at week 4 and week 19
timeFrame: Baseline, week 4, week 19
measure: Change from the use of health care service at week 4 and week 19
timeFrame: Baseline, week 4, week 19
measure: Change from the use of medications at week 4 and week 19
timeFrame: Baseline, week 4, week 19
measure: Change from rate of sickness at week 4 and week 19
timeFrame: Baseline, week 4, week 19
measure: Change from workability at week 4 and week 19
timeFrame: Baseline, week 4, week 19
measure: Change from ICF functionality at week 4 and week 19
timeFrame: Baseline, week 4, week 19
measure: Change from sleep quality at week 4 and week 19
timeFrame: Baseline, week 4, week 19
measure: Change from depression symptoms at week 4 and week 19
timeFrame: Baseline, week 4, week 19
measure: Change from anxiety symptoms at week 4 and week 19
timeFrame: Baseline, week 4, week 19
measure: Change from resilience at week 4 and week 19
timeFrame: Baseline, week 4, week 19
measure: Change from cognition at week 4 and week 19
timeFrame: Baseline, week 4, week 19
measure: Change from cognitive impairment at week 4 and week 19
timeFrame: Baseline, week 4, week 19
Other outcomes:
Locations:
city: Schönau Am Königssee
country: Germany
facility: Schone Klinik Berchtesgadener Land
Study officials:
affiliation: Schön Klinik Berchtesgadener Land
name: Andreas R Koczulla, PROF
role: PRINCIPAL_INVESTIGATOR
References: