Loading clinical trials...
Loading clinical trials...
Impact of Inflamatory Bowel Disease Activity on Frailty in Patients Over 60 Years
The goal of this observational, multicenter, descriptive, prospective, and longitudinal study is to evaluate the impact of IBD activity on frailty in a prospective and longitudinal cohort of patients with IBD, and also to assess the impact of frailty on the risk of hospitalization and mortality in patients with IBD aged ≥60 years. The main questions it aims to answer are: 1. Can frailty and consequently the risk of complications (adverse events, hospitalization, and mortality) be reversed through proactive treatment in frail patients with active inflammatory bowel disease? 2. Which frailty index is the most effective for predicting the risk of complications in patients with active inflammatory bowel disease? At inclusion, clinical frailty indices will be calculated. Additionally, clinical variables related to IBD and comorbidities will be recorded. During follow ups visits frailty, comorbidities, IBD activity, changes in medical treatment for IBD, adverse effects, hospitalizations, and mortality will be reassessed.
All consecutive patients meeting the selection criteria in the participating centres will be invited to participate. -At inclusion, 4 clinical frailty indices (CFS-Clinical Frailty Scale, FRAGIL-VIG, Fried, VES-13) will be calculated. In addition, clinical variables on IBD (diagnosis, phenotype, extraintestinal manifestations, perianal disease, time of evolution of the disease, active treatments at the time of inclusion, treatment initiated, diagnostic tests available at the time of inclusion) and comorbidities (allowing calculation of the Charlson and Cumulative Illness Rating Scale for Geriatriscs \[CIRS-G\] indices) will be recorded. Follow-up: a total of 3 follow-up visits will be conducted (at 3, 6 and 12 months) where frailty, comorbidities, IBD activity, changes in IBD medical treatment, adverse effects, hospitalisations and mortality will be reassessed.
Age
60 - No limit years
Sex
ALL
Healthy Volunteers
No
Hospital Universitario Araba
Vitoria-Gasteiz, Alava, Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Althaia Manresa
Manresa, Barcelona, Spain
Hospital del Mataró
Mataró, Barcelona, Spain
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain
Hospital Mútua de Terrassa
Terrassa, Barcelona, Spain
Hospital Viladecans
Viladecans, Barcelona, Spain
Hospital Sierrallana de Torrelavega
Torrelavega, Cantabria, Spain
Hospital de Toledo
Toledo, Castille-La Mancha, Spain
Start Date
April 14, 2025
Primary Completion Date
April 1, 2026
Completion Date
May 1, 2027
Last Updated
December 24, 2025
153
ESTIMATED participants
Lead Sponsor
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
NCT06833957
NCT07245394
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions