NCT05500040

Changes in Faecal Calprotectin Levels and Participation-related Scores Following Three Weeks of Inpatient Rehabilitation

Veränderungen Des Faecalen Calprotectinwertes Und Teilhabebezogener Scores in Folge Einer Dreiwöchigen Phase II Rehabilitation [Changes in Faecal Calprotectin Levels and Participation-related Scores Following Three Weeks of Inpatient Rehabilitation]

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 226 (actual)
• Sponsor: Pensionsversicherungsanstalt · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

For many people affected by inflammatory bowel disease (IBD), their quality of life and their ability to participate in their professional and social lives are severely restricted. Rehabilitation measures based on the biopsychosocial ICF model aim to support the restoration of these abilities. Physiological parameters (e.g. biomarkers) as well as patient-reported outcomes (PROs) can be used to assess the success of ICF-based rehabilitation measures and to optimize them. A suitable biomarker to monitor inflammation in IBD patients is faecal calprotectin. In addition, PROs that support patients in providing information, for example on their health-related quality of life or on their subjective ability to work, can provide information on the individual social and occupational participation ability of the patients. The aim of this project is to investigate changes in a biomarker (calprotectin) as well as in selected PROs after a three-week inpatient phase II rehabilitation.

Conditions

• Crohn Disease
• Ulcerative Colitis

Interventions

Type	Name	Description
BEHAVIORAL	Multimodal Rehabilitation	The rehabilitation measure is based on the biopsychosocial ICF model of the WHO. A multidisciplinary team of therapists looks after the patients during their stay in rehabilitation. Taking into account the physical and psychological condition of the patients, an individual therapy plan is created that is tailored to their needs.

Timeline

• Start date: 2022-08-09
• Primary completion: 2023-07-26
• Completion: 2023-07-26
• First posted: 2022-08-12
• Last updated: 2025-03-10

Locations

1 site across 1 country: Austria