COPD, Sarcopenic Obesity
Conditions
Brief summary
This study aims to explore the diagnosis, impact, and prognostic factors of COPD complicated with sarcopenic obesity using multi-segment bioelectrical impedance phase angle technology. It seeks to clarify the diagnostic value and efficacy of body composition analysis in specific populations, analyze the relationship between phase angle and COPD severity as well as quality of life, investigate its predictive role for adverse outcomes, and reveal the effects of inflammation and metabolic disorders in sarcopenic obesity. The goal is to provide a basis for early screening and precise intervention to improve patient prognosis.
Detailed description
The primary objective of this study is to use multi-segment bioelectrical impedance phase angle technology to explore the diagnosis, impact, and prognostic factors of COPD complicated with sarcopenic obesity. The study aims to clarify the diagnostic value and efficacy of body composition analysis in specific populations, analyze the relationship between phase angle and COPD severity as well as quality of life, investigate its predictive role for adverse outcomes, and reveal the effects of inflammation and metabolic disorders in sarcopenic obesity. The goal is to provide a basis for early screening and precise intervention to improve patient prognosis.
Interventions
DEVICEInBody S10
Bioelectrical Impedance Phase Angle Technology Measured via InBody S10 at six frequencies (1kHz-1000kHz) during each follow-up
Sponsors
Fudan University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age over 65 years; 2. Ability to complete physical activity assessments and pulmonary function tests; 3. Complete medical records, willingness to adhere to follow-up arrangements, and provision of adverse event reports via telephone or outpatient visits, with signed informed consent; 4. COPD diagnosis based on the American Thoracic Society (ATS)/European Respiratory Society (ERS) GOLD definition, with a post-bronchodilator FEV1/FVC ratio \< 0.70, current or former smokers with a smoking history of ≥10 pack-years.
Exclusion criteria
1. Severe cognitive impairment or hand deformities (e.g., rheumatoid arthritis) preventing body composition measurements; 2. Incomplete clinical or follow-up data or unwillingness/inability to undergo regular follow-up; 3. Severe systemic edema; 4. Presence of cardiac pacemakers or significant metal implants that may interfere with measurements; 5. Voluntary withdrawal for any reason, including loss to follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in pulmonary function | 6, 12, and 24 months | FEV1% |
| COPD Assessment Test (CAT) | 6, 12, and 24 months | The COPD Assessment Test (CAT) is a short, validated questionnaire used to measure the impact of COPD symptoms on a patient's daily life and health status. It consists of 8 simple questions, each scored from 0 to 5, with a total range of 0-40.Higher CAT scores = Worse COPD symptoms \& greater disease burden |
| Body composition | 6, 12, and 24 months | Segmental phase angles measured via bioelectrical impedance analysis |
| Dyspnea Scale | 6, 12, and 24 months | The Modified Medical Research Council(mMRC) scale is a simple questionnaire used to assess the severity of breathlessness, primarily in respiratory diseases like COPD.range from 0-4 .Grading Criteria:Grade 1: Short of breath when walking fast or climbing a slight hill.Grade 2: Walk slower than peers or need to stop occasionally due to breathlessness.Grade 3: Stop to breathe after walking \~100 meters or a few minutes on level ground.Grade 4: Too breathless to leave home, or breathless while dressing/undressing.A higher mMRC grade correlates with greater dyspnea severity and more pronounced symptoms." |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute exacerbations | 6, 12, and 24 months | An acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is defined as:An acute worsening of respiratory symptoms that results in additional therapy. |
| Hospitalizations | 6, 12, and 24 months | Frequency of hospitalizations |
| Mortality | 24 months | Mortality based on Mal-Nutritional Status |
| CBC | 6, 12, and 24 months | Serum level of WBC (ELISA) |
| CRP | 6, 12, and 24 months | Serum level of C-Reactive Protein (ELISA) |
| albumin | 6, 12, and 24 months | Serum level of albumin |
| IL-6 | 6, 12, and 24 months | Serum level of Interleukin-6 |
| TNF-α | 6, 12, and 24 months | Serum level of Tumor Necrosis Factor-alpha |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORYinggang Zhu, MD, PhD
Huadong Hospital
Outcome results
None listed