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

NCT06124625 | Active Not Recruiting

• 1 other identifier: Reload 2.0
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-COVID-19 Syndrome

Keywords

rehabilitation; maintenance program

Outcome Measures

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

  Baseline, week 4, week 19

Secondary Outcomes (17)

• Change from baseline post-COVID-related symptoms at week 4 and week 19

  Baseline, week 4, week 19

• Change from baseline lung function at week 4 and week 19

  Baseline, week 4, week 19

• Change from baseline fatigue symptoms at week 4 and week 19

  Baseline, week 4, week 19

• Change from baseline exercise capacity at week 4 and week 19

  Baseline, week 4, week 19

• Change from baseline physical activity at week 4 and week 19

  Baseline, week 4, week 19

Study Arms (2)

Rehabilitation maintenance program

ACTIVE COMPARATOR

Procedure: Rehabilitation combined to a digital maintenance program

No Rehabilitation maintenance program

PLACEBO COMPARATOR

Procedure: Rehabilitation without maintenance program

Interventions

Rehabilitation combined to a digital maintenance program PROCEDURE

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 maintenance program

Rehabilitation without maintenance program PROCEDURE

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

No Rehabilitation maintenance program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• No internet access

Sponsors & Collaborators

• Schön Klinik Berchtesgadener Land: lead
• Bavarian State Ministry of Health and Care (Funding): collaborator
• Deutsche Rentenversicherung (German pension insurance): collaborator
• Betriebskrankenkassen Landesverband Bayern (Bavarian health insurance) (Design): collaborator

Study Sites (1)

Schone Klinik Berchtesgadener Land

Schönau am Königssee, 83471, Germany

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Andreas R Koczulla, PROF

  Schön Klinik Berchtesgadener Land

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of pulmonology, head of institute for pulmonary rehabilitation research

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 9, 2023
• Study Start: January 31, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

DE (1)