FODEPOC Study: Fat-free Mass Index in Copd

NCT05853081 | Unknown

• 1 other identifier: FODEPOC
• Study Type: observational
• Target: 237
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Obstructive Pulmonary Disease

Keywords

COPD; prognosis; nutrition assessment

Outcome Measures

Primary Outcomes (6)

• Fat Free Mass Index

  Weight in kilograms and body fat percentage will be measured by bioelectrical impedance analysis, and height in meters. Weight, height and boday fat percentage will be combined to report Fat Free Mass Index.

  Baseline

• Incidence of exacerbations

  Total frequency of exacerbations, frequency of exacerbations that required hospitalization and exacerbations free period since baseline.

  12 months after inclusion

• Forced Expiratory Volumen in the first second

  Mililiters of expired volume in the first second during a forced spirometry

  Baseline

• Body Mass Index

  Weight in kilograms and and height in meters. Weight and height will be combined to report Body Mass Index

  Baseline

• Dyspnea

  Dyspnea degree measured by the modified Medical Research Council Dyspnea Scale. Score ranges from 0 to 4, higher scores indicate worse dyspnea.

  Baseline, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months after inclusion

• 6 minute walking test

  Distance covered during 6 minutes of walking, measured in meters

  Baseline, 1 year, 2 years, 3 years

Secondary Outcomes (4)

• Changes in COPD clinical status

  Baseline, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months after inclusion

• Incidence of mortality

  Baseline, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months after inclusion

• COPD health related quality of life

  Baseline, 1 year, 2 years, 3 years

• Major cardiovascular events

  Baseline, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months after inclusion

Study Arms (3)

FEV1 < 30%

open groups with forced expiratory flow in the first second (FEV1) \< 30%. It will be followed for at least two years.The fat-free mass index (FFMI) will be measured instead of the body mass index (BMI) with bioelectrical impedance analysis.

Diagnostic Test: Bioelectrical impedance analysis

FEV1 30-50%

open groups with forced expiratory flow in the first second (FEV1) \< 30%. It will be followed for at least two years.The fat-free mass index (FFMI) will be measured instead of the body mass index (BMI) with bioelectrical impedance analysis.

Diagnostic Test: Bioelectrical impedance analysis

FEV1 > 50%

open groups with forced expiratory flow in the first second (FEV1) \< 30%. It will be followed for at least two years.The fat-free mass index (FFMI) will be measured instead of the body mass index (BMI) with bioelectrical impedance analysis.

Diagnostic Test: Bioelectrical impedance analysis

Interventions

Bioelectrical impedance analysis DIAGNOSTIC_TEST

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.

FEV1 30-50%; FEV1 < 30%; FEV1 > 50%

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

population will be selected from pulmonology hospital consultations

You may qualify if:

• Informed consent.
• Man or woman \> 40 years.
• Smoker or former smoker with a pack-years index ≥ 10.
• Clinical stability will always be defined according to the following criteria:
• Patients should be able to perform all procedures necessary for the study at the discretion of the investigator, including: acceptable and reproducible spirometry; 6-minute walking test; bioelectrical impedance analysis

You may not qualify if:

• Patients with another significant disease other than COPD (neoplastic, cardiovascular, metabolic, infectious or any clinical condition) as a foreseeable cause of death in the period of less than one year or that may cause a significant alteration of the nutritional status of the patient.
• Taking nutritional supplements and / or anabolic drugs in the last 12 months.

Sponsors & Collaborators

• Hospital General Universitario Gregorio Marañon: lead

Study Sites (1)

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

RECRUITING

Related Publications (26)

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Daniel López Padilla, PhD

CONTACT

+34915863330; lopez.padilla84@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor Daniel López Padilla

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: May 10, 2023
• Study Start: September 22, 2023
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: September 25, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)