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

NCT ID: NCT05500040

Last Updated: 2025-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

226 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-09

Study Completion Date

2023-07-26

Brief Summary

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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.

Detailed Description

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Conditions

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Crohn Disease Ulcerative Colitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with IBD - Crohn's Disease

Multimodal Rehabilitation

Intervention Type BEHAVIORAL

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.

Patients with IBD - Ulcerative Colitis

Multimodal Rehabilitation

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of Crohn's Disease or Ulcerative Colitis
* Participation in an inpatient phase II rehabilitation

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pensionsversicherungsanstalt

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Doreen Stöhr, Mag.

Role: STUDY_CHAIR

Pensionsversicherungsanstalt

Locations

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Rehabilitationszentrum Bad Aussee

Vienna, Styria, Austria

Site Status

Countries

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Austria

Other Identifiers

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0008-CED

Identifier Type: -

Identifier Source: org_study_id

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