Research on the Construction of a Prognostic Model for COPD Complicated With Sarcopenic Obesity Based on Bioelectrical Impedance Phase Angle Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Changes in pulmonary function
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 65 years;
- •Ability to complete physical activity assessments and pulmonary function tests;
- •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;
- •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.
排除标准
- •Severe cognitive impairment or hand deformities (e.g., rheumatoid arthritis) preventing body composition measurements;
- •Incomplete clinical or follow-up data or unwillingness/inability to undergo regular follow-up;
- •Severe systemic edema;
- •Presence of cardiac pacemakers or significant metal implants that may interfere with measurements;
- •Voluntary withdrawal for any reason, including loss to follow-up.
研究组 & 干预措施
COPD with sarcopenic obesity
COPD with sarcopenic obesity based on Bioelectrical Impedance Phase Angle Technology by the enrollment
干预措施: InBody S10 (Device)
COPD without sarcopenic obesity
COPD without sarcopenic obesity based on Bioelectrical Impedance Phase Angle Technology by the enrollment
干预措施: InBody S10 (Device)
结局指标
主要结局
Changes in pulmonary function
时间窗: 6, 12, and 24 months
FEV1%
COPD Assessment Test (CAT)
时间窗: 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
时间窗: 6, 12, and 24 months
Segmental phase angles measured via bioelectrical impedance analysis
Dyspnea Scale
时间窗: 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."
次要结局
- albumin(6, 12, and 24 months)
- CBC(6, 12, and 24 months)
- CRP(6, 12, and 24 months)
- IL-6(6, 12, and 24 months)
- Acute exacerbations(6, 12, and 24 months)
- Hospitalizations(6, 12, and 24 months)
- Mortality(24 months)
- TNF-α(6, 12, and 24 months)
研究者
Zhijun Bao
Hospital director
Fudan University