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FODEPOC Study: Fat-free Mass Index in Copd

NCT05853081 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 237

Last updated 2023-09-25

No results posted yet for this study

Summary

General Objective: To compare the prognostic value of the FODE scale for COPD exacerbations, where the fat-free mass index (FFMI) will be measured instead of the body mass index (BMI) in the BODE scale. Specific objectives: to describe the nutritional status of COPD patients according by the GesEPOC and GOLD phenotypes; to compare the mortality prognostic value of FODE with BODE; to compare the exacerbations and mortality prognostic value of the BODCAT scale, which includes the CAT questionnaire instead of the six-minute walking test (6MWT), with BODE; to compare the mortality prognostic value of the FODE and FODEx scales, where the BMI and the 6MWT will be substituted by the FFMI and the severe exacerbations in the previous year, respectively, with BODE and BODEx. Methods: prospective, with no intervention besides the recommendations of COPD clinical guidelines, where patients will be allocated into three parallel and open groups according to their forced expiratory flow in the first second (FEV1) in the fashion FEV1 \< 30%: FEV1 30-50% : FEV1 \> 50%, and will be followed for at least two years. FFMI will be measured using bioelectrical impedance analysis. Exacerbations and mortality will be recorded during follow-up to evaluate the prognostic value of the FODE scale, which hypothetically will increase in 10% the prognostic value of the BODE scale.

Conditions

Interventions

DIAGNOSTIC_TEST

Bioelectrical impedance analysis

The Fat-free mass index (FFMI) will be measured using bioelectrical impedance analysis. Exacerbations and mortality will be recorded during follow-up to evaluate the prognostic value of the FODE scale.

Sponsors & Collaborators

  • Hospital General Universitario Gregorio Marañon

    lead OTHER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-22
Primary Completion
2024-06-30
Completion
2024-12-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05853081 on ClinicalTrials.gov