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

Post-COVID-19 Syndrome Clinical Trial

— ReLoAd2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06124625
• Other study ID #: Reload 2.0
• Status: Recruiting
• Phase: N/A
• Start date: January 31, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: March 2024
• Source: Schön Klinik Berchtesgadener Land
• Contact: Inga Jarosch, DR
• Phone: +498652-93
• Email: ijarosch[@]schoen-klinik.de
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 28, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Post-COVID-syndrome (Definition WHO)

• Entered the rehabilitation process at the Schoen Klinik Berchtesgadener Land

Exclusion Criteria:

• No internet access

Related Conditions & MeSH terms

• COVID-19
• Post-COVID-19 Syndrome

Intervention

Procedure:
• Rehabilitation 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.
• Rehabilitation without maintenance program
Individuals in this group undergo a 3-week inpatient rehabilitation program followed by a 12-week usual care period.

Locations

Country	Name	City	State
Germany	Schone Klinik Berchtesgadener Land	Schönau Am Königssee

Sponsors (4)

Lead Sponsor	Collaborator
Schön Klinik Berchtesgadener Land	Bavarian State Ministry of Health and Care (Funding), Betriebskrankenkassen Landesverband Bayern (Bavarian health insurance) (Design), Deutsche Rentenversicherung (German pension insurance)

Country where clinical trial is conducted

Germany, 

Outcome

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