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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD with sarcopenic obesity | COPD with sarcopenic obesity based on Bioelectrical Impedance Phase Angle Technology by the enrollment |
| |
| COPD without sarcopenic obesity | COPD without sarcopenic obesity based on Bioelectrical Impedance Phase Angle Technology by the enrollment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InBody S10 | Device | Bioelectrical Impedance Phase Angle Technology Measured via InBody S10 at six frequencies (1kHz-1000kHz) during each follow-up |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in pulmonary function | FEV1% | 6, 12, and 24 months |
| COPD Assessment Test (CAT) | 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 | 6, 12, and 24 months |
| Body composition | Segmental phase angles measured via bioelectrical impedance analysis | 6, 12, and 24 months |
| Dyspnea Scale | 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." | 6, 12, and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Acute exacerbations | An acute exacerbation of chronic obstructive pulmonary disease (AECOPD) is defined as:An acute worsening of respiratory symptoms that results in additional therapy. | 6, 12, and 24 months |
| Hospitalizations |
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Inclusion Criteria:
Exclusion Criteria:
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The elderly COPD patients measured with bioelectrical impedance phase angle technology
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| Name | Affiliation | Role |
|---|---|---|
| Yinggang Zhu, MD, PhD | Huadong Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huadong hospital, Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 15, 2025 | Jan 23, 2026 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Frequency of hospitalizations
| 6, 12, and 24 months |
| Mortality | Mortality based on Mal-Nutritional Status | 24 months |
| CBC | Serum level of WBC (ELISA) | 6, 12, and 24 months |
| CRP | Serum level of C-Reactive Protein (ELISA) | 6, 12, and 24 months |
| albumin | Serum level of albumin | 6, 12, and 24 months |
| IL-6 | Serum level of Interleukin-6 | 6, 12, and 24 months |
| TNF-α | Serum level of Tumor Necrosis Factor-alpha | 6, 12, and 24 months |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |