Impact of IBD 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.

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Key information

Conditions

IBD

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Araba, Vitoria-Gasteiz, Alava, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients aged ≥60 years with IBD (Crohn's disease or ulcerative colitis) diagnosed according to ECCO criteria and under follow-up in the IBD units of participating centers.
Initiation of medical treatment (oral mesalazine, topical or systemic corticosteroids, immunosuppressants, and/or biologics) due to clinical activity based on PRO2 scales (UC: PRO >4; CD: PRO2 >14) and/or biological activity (fecal calprotectin ≥500 mg/kg, C-reactive protein ≥10 mg/L).
Signed informed consent for inclusion.

Exclusion criteria

Lack or withdrawal of informed consent.
Unclassified/indeterminate colitis.
Change in medical treatment solely due to adverse events.
Initiation of treatment only with salicylates and/or topical steroids for disease activity.
Treatment intensification to manage disease activity.
Patients with an ostomy.
Comorbidities with a life expectancy of less than one year.

Treatment and study plan

Primary outcomes

To evaluate the impact of inflamatory bowel disease (IBD) activity on frailty in a prospective and longitudinal cohort of patients with IBD.

Time frame: 12 months

The evaluation of the impact of IBD activity will be measured by Patient Reported outcomes 2 (PRO-2).

IBD clinical activity measured by PRO-2 for Crohn's disease (CD) is composed by:

CD-PRO2: number of liquid daily stools and abdominal pain (0=none; 1=low; 2= moderate; 3= severe).

IBD clinical activity measured by PRO-2 for ulcerative colitis (UC) is composed of 2 parts:

UC-PRO2: stool number respect basal (0 =normal, same as usual; 1 = 1-2 stools more than the usual; 2 = 3-4 stools more than the usual; 3 = 5 or more stools more than the usual) and rectal bleeding (0 = none; 1 = visible blood in fences at least in half of them; 2 = visible blood in fences > half of them or mores; 3 = only blood).

Clinic-biological activity: PRO2>4 in UC; PRO2>14 in CD
To assess the impact of frailty on the risk of hospitalization and mortality in patients with IBD aged ≥60 years.

Time frame: 12 months

The assessment of the impact of frailty will be measured by Fried Index. Fried Index is composed by a sum up of 5 parts, that follows:

Unintended weight loss (score 0-1), Self-reported fatigue (score 0-1), Creep speed (score 0-1), Low physical activity (score 0-1), Weakness (score 0-1),

The result of the total score is: Frail 3-5 points, pre- frail 1-2 points, "fit" 0 points.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Casas

CONTACT

[email protected]

Erika Araya

CONTACT

[email protected]

+34 674682070

Sponsors and collaborators

Lead sponsor

Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Other

Registry information

Official study title

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

Acronym: FRAGIL

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Feb 25, 2025
Registry last updated: May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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