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

Completed

• Conditions: Ulcerative Colitis; Crohn Disease
• Interventions: Behavioral: Multimodal Rehabilitation

• Registration Number: NCT05500040
• Lead Sponsor: Pensionsversicherungsanstalt

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-09
• Study First Submitted: 2022-08-09
• Study First Submitted QC: 2022-08-11
• Study First Posted: 2022-08-12
• Primary Completion: 2023-07-26
• Study Completion: 2023-07-26
• Status Verified: 2024-01
• Last Update Submitted: 2025-03-06
• Last Update Posted: 2025-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with IBD - Ulcerative Colitis	Multimodal Rehabilitation	-
Patients with IBD - Crohn's Disease	Multimodal Rehabilitation	-

Primary Outcome Measures

Name	Time	Method
Faecal Calprotectin	3 weeks of inpatient rehabilitation	Faecal calprotectin is a biochemical measurement of the protein calprotectin in the stool. Elevated faecal calprotectin indicates the migration of neutrophils to the intestinal mucosa, which occurs during intestinal inflammation, including inflammation caused by inflammatory bowel disease.
European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L)	3 weeks of inpatient rehabilitation	The EQ-5D-5L is a general instrument for measuring patient-reported outcomes (PROs), which can be used to assess the quality of life of patients on different dimensions (mobility, self-care, usual activities, pain/discomfort) on a 5-level scale (Min. = 0, Max. = 5). Lower values indicate less impairments in the respective dimensions.; Moreover, the EQ-5D-5L assesses the patient's self-rated health on a 100 point visual analog scale (Min. = 0, Max. = 100). Lower values indicate less positive ratings of health.
Patient Health Questionnaire-4 (PHQ-4)	3 weeks of inpatient rehabilitation	The Patient Health Questionnaire-4 (PHQ-4) operationalizes core criteria for anxiety and depression on a 4 point likert scale (Min. = 0, Max = 4). Lower values indicate less impairments.
Work ability index (WAI)	3 weeks of inpatient rehabilitation	The Work Ability Index (WAI) is an instrument for assessing work ability. (Min. = 7, Max = 49). Lower values indicate less subjective work ability.
Ced Disk	3 weeks of inpatient rehabilitation	The Ced Disk measures IBD-related impairments in different dimensions i.e., abdominal pain, bowel control, interpersonal interactions, education and work, sleep, energy, emotions, body image, sexuality, joint pain (Min. = 0, Max. = 10). Lower values indicate less impairments in the respective dimensions.

Trial Locations

Locations (1)

Rehabilitationszentrum Bad Aussee; 🇦🇹 Vienna, Styria, Austria