NCT07541053

Brief Summary

The effects of low fat-free mass in Prognosis of people with chronic obstructive pulmonary disease (COPD) as regard clinical evaluation using BODE index, GOLD ABE assessment ( Gold 2024 ) functional evaluation using spirometry and 6 min walk test and radiological evaluation by computed chest tomography.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 15, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 15, 2026

Last Update Submit

April 15, 2026

Conditions

Keywords

COPDFFMI

Outcome Measures

Primary Outcomes (1)

  • Fat-free Mass in Chronic Obstructive Pulmonary Disease

    Functional evaluation using 6 min walk test distance (meter)

    6 months

Study Arms (2)

Group A: COPD patients with low FFM

Defined as fat-free mass refers primarily to muscle mass, especially while considering body composition and weight management.

Group B : COPD patients with normal FFM

with normal or high FFM with matched age and sex to the patients group.

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

* Group A: COPD patients with low FFM which is defined as fat-free mass refers primarily to muscle mass, especially while considering body composition and weight management. * Group B: COPD patients with normal FFM with matched age and sex to the patients group.

You may qualify if:

  • Were adults aged ≥40 years with a clinical diagnosis of COPD confirmed by spirometry showing post-bronchodilator FEV₁/FVC \<0.70 according to GOLD 2024 criteria

You may not qualify if:

  • Exacerbation within the preceding month, active pulmonary infection, physical disability precluding study measurements (e.g., musculoskeletal or neurological disorders), advanced heart failure (NYHA class III-IV), malignancy or hyperthyroidism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura Univeristy Chest Medicine

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mohamed Abd ElMoniem

    Lectruer of chest medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of chest medicine

Study Record Dates

First Submitted

April 15, 2026

First Posted

April 21, 2026

Study Start

April 1, 2024

Primary Completion

October 1, 2024

Study Completion

April 1, 2025

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations