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Low Fat-free Mass in Prognosis of People With Chronic Obstructive Pulmonary Disease

M

Mansoura University

Status

Completed

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study type

Observational

Funder types

Other

Identifiers

NCT07541053
MS.24.2.2706

Details and patient eligibility

About

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.

Full description

Chronic obstructive pulmonary disease (COPD) is a heterogeneous lung condition characterized by chronic respiratory symptoms (dyspnea, cough, sputum production and \ or exacerbations) due to abnormalities of the airways (bronchitis, bronchiolitis) and\ or alveoli (emphysema) that cause persistent, often progressive, airflow obstruction.

COPD is characterized by a progressive and irreversible decline in lung function. In addition, COPD is recognized as a systemic disease with significant extra pulmonary effects.

Loss of skeletal muscle mass is a well described and clinically relevant systemic consequence of COPD. Across the disease severity spectrum of COPD, the prevalence of abnormally low muscle mass (i.e. sarcopenia or cachexia) is estimated to be ∼23%.

The etiology of muscle dysfunction in COPD is complex and multifactorial. Proposed pathophysiological mechanisms include 1) disease-related factors such as systemic inflammation; 2) ageing; and 3) behavior modification, particularly less time spent physically active and more time spent sedentary.

The rate of age-related decline in skeletal muscle function is accelerated in people with COPD compared to that of otherwise healthy adults (Limpawattana et al., 2018). Additionally, loss of muscle function begins early in the disease course, with ostensible muscle dysfunction observed in people with mild COPD.

Importantly, low muscle mass is not just a systemic manifestation affecting people with COPD who are underweight, but also those who are pre-obese or obese, termed sarcopenic obesity, which is similarly associated with poor health outcomes in COPD (Machado et al., 2023). People with COPD who possess higher muscle or fat-free mass have a better quality of life and prognosis.

In addition, a significant positive association between muscle or fat-free mass and exercise tolerance in COPD has been also shown. This has led to low muscle mass being recognized as a treatable trait of COPD to help alleviate disease burden and improve clinical health outcomes.

Enrollment

90 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Trial design

90 participants in 2 patient groups

Group A: COPD patients with low FFM
Description:
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
Description:
with normal or high FFM with matched age and sex to the patients group.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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