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

Study Overview
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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.

Official Title
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Effects of Rehabilitation Combined With a 12-week Maintenance Program Compared to Rehabilitation Alone in Post-COVID-19 - a Randomized, Controlled Trial.

Conditions
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Post-COVID-19 Syndrome

Intervention / Treatment
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* Procedure: Rehabilitation combined to a digital maintenance program
* Procedure: Rehabilitation without maintenance program


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rehabilitation maintenance program<br> | Procedure: Rehabilitation combined to a digital maintenance program<br>* 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.<br>|
| Placebo Comparator: No Rehabilitation maintenance program<br> | Procedure: Rehabilitation without maintenance program<br>* Individuals in this group undergo a 3-week inpatient rehabilitation program followed by a 12-week usual care period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, week 4, week 19 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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]. | Baseline, week 4, week 19 | 
| Change from baseline lung function at week 4 and week 19 | following Parameters will be collected:Pimax | Baseline, week 4, week 19 | 
| Change from baseline fatigue symptoms at week 4 and week 19 | Fatigue Assessment Scale will be used | 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) | 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 | Baseline, week 4, week 19 | 
| Change from baseline quality of life at week 4 and week 19 | EQ-5D-5L questionnaire will be used. | 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. | 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. | Baseline, week 4, week 19 | 
| Change from rate of sickness at week 4 and week 19 | Days of sickness will be documented. | Baseline, week 4, week 19 | 
| Change from workability at week 4 and week 19 | Work ability index will be used | 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. | 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) | 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 | 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 | Baseline, week 4, week 19 | 
| Change from resilience at week 4 and week 19 | Resilience scale RS-13 will be used. | 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). | 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) | Baseline, week 4, week 19 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rehabilitation, maintenance program