Actively Recruiting

Age: 60Years +
All Genders
ID06844318

Impact of Inflammatory Bowel Disease Activity on Frailty in Patients Over 60 Years

Led by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa · Updated on 2026-05-07

153

Participants Needed

34

Research Sites

43 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how inflammatory bowel disease (IBD) activity affects frailty in patients aged 60 years and older. This observational, multicenter, prospective, and longitudinal study aims to understand if frailty and related risks like hospitalization and mortality can be reversed with proactive treatment in frail patients with active IBD. The study also evaluates which frailty index best predicts complications in this population. At the start, four clinical frailty indices will be calculated for each participant, alongside recording clinical variables related to IBD and other health conditions. Patients will be followed through three visits at 3, 6, and 12 months, during which frailty, disease activity, treatment changes, adverse effects, hospitalizations, and mortality will be reassessed to track progress and outcomes. Participants will be involved in these visits where various assessments will be done, including measuring frailty and comorbidities and reviewing their IBD activity and treatments. The main outcomes include assessing the impact of IBD activity on frailty and how frailty affects hospitalization and mortality risk over a 12-month period. The study is led by the Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa and runs until May 2027.

CONDITIONS

Brief Title

Impact of IBD Activity on Frailty in Patients Over 60 Years

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 60 years or older with Crohn's disease or ulcerative colitis diagnosed by ECCO criteria and followed in IBD units
  • Starting medical treatment for active IBD based on clinical or biological activity
  • Signed informed consent for participation
Not Eligible

You will not qualify if you...

  • No or withdrawn informed consent
  • Unclassified or indeterminate colitis diagnosis
  • Treatment change only due to adverse events
  • Treatment initiated only with salicylates or topical steroids for disease activity
  • Treatment intensification to manage disease activity
  • Presence of an ostomy
  • Comorbidities with life expectancy under one year

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

At inclusion, participants have clinical frailty indices calculated and clinical variables on IBD and comorbidities recorded.

1 baseline visit (in-person)

Long-term Monitoring

Duration - 12 months

Participants are followed for 12 months with reassessments of frailty, comorbidities, IBD activity, treatment changes, adverse effects, hospitalisations, and mortality.

3 follow-up visits at 3, 6, and 12 months

Trial Site Locations

Total: 34 locations

1

Hospital Universitario Araba

Vitoria-Gasteiz, Alava, Spain, 01009

Actively Recruiting

2

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Actively Recruiting

3

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Actively Recruiting

4

Althaia Manresa

Manresa, Barcelona, Spain

Actively Recruiting

5

Hospital del Mataró

Mataró, Barcelona, Spain

Actively Recruiting

6

Consorci Sanitari de Terrassa

Terrassa, Barcelona, Spain

Actively Recruiting

7

Hospital Mútua de Terrassa

Terrassa, Barcelona, Spain

Actively Recruiting

8

Hospital Viladecans

Viladecans, Barcelona, Spain

Actively Recruiting

9

Hospital Sierrallana de Torrelavega

Torrelavega, Cantabria, Spain

Actively Recruiting

10

Hospital de Toledo

Toledo, Castille-La Mancha, Spain

Actively Recruiting

11

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, Las Palmas, Spain

Actively Recruiting

12

Hospital de Henares

San Sebastián de los Reyes, Madrid, Spain

Actively Recruiting

13

Hospital San Agustín de Avilés

Avilés, Principality of Asturias, Spain

Actively Recruiting

14

Hospital de Cabueñes

Gijón, Principality of Asturias, Spain

Actively Recruiting

15

Hospital Universitario Central de Astúrias

Oviedo, Principality of Asturias, Spain

Actively Recruiting

16

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain

Actively Recruiting

17

Hospital Dr Balmis

Alicante, Valencia, Spain

Actively Recruiting

18

Hospital Denia

Denia, Valencia, Spain

Actively Recruiting

19

Hospital Royo Villanova

San Gregorio, Zaragoza, Spain

Actively Recruiting

20

Complejo Asistencial de Ávila

Ávila, Spain

Actively Recruiting

21

Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

Actively Recruiting

22

Hospital Universitario de Burgos

Burgos, Spain

Actively Recruiting

23

Hospital Universitari Dr Josep Trueta

Girona, Spain

Actively Recruiting

24

Hospital Juan Ramón Jiménez

Huelva, Spain

Actively Recruiting

25

Hospital Universitario Lucus Augusti

Lugo, Spain

Actively Recruiting

26

Hospital Infanta Elena

Madrid, Spain, 28342

Actively Recruiting

27

Hospital Puerta de Hierro Majadahonda

Madrid, Spain

Actively Recruiting

28

Hospital Ramon y Cajal

Madrid, Spain

Actively Recruiting

29

Hospital Universitario Infanta Leonor

Madrid, Spain

Actively Recruiting

30

Complexo Hospitalario Universitario de Ourense

Ourense, Spain

Actively Recruiting

31

Hospital Universitario Ntra. Sra. de Candelaria

Santa Cruz de Tenerife, Spain

Actively Recruiting

32

Hospital General Universitario de Valencia

Valencia, Spain

Actively Recruiting

33

Hospital Universitario de la Fe

Valencia, Spain

Actively Recruiting

34

Hospital Lozano Blesa

Zaragoza, Spain

Actively Recruiting

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Research Team

E

Erika Araya

A

Anna Casas

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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