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NCT Number: NCT07136246

A Prognostic Model for COPD Complicated With Sarcopenic Obesity Based on Bioelectrical Impedance Phase Angle Technology

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Huadong hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

InBody S10

Device

Bioelectrical Impedance Phase Angle Technology Measured via InBody S10 at six frequencies (1kHz-1000kHz) during each follow-up

Primary outcomes

  1. Changes in pulmonary function

    Time frame: 6, 12, and 24 months

    FEV1%

  2. COPD Assessment Test (CAT)

    Time frame: 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

  3. Body composition

    Time frame: 6, 12, and 24 months

    Segmental phase angles measured via bioelectrical impedance analysis

  4. Dyspnea Scale

    Time frame: 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 outcomes

  1. Acute exacerbations

    Time frame: 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.

  2. Hospitalizations

    Time frame: 6, 12, and 24 months

    Frequency of hospitalizations

  3. Mortality

    Time frame: 24 months

    Mortality based on Mal-Nutritional Status

  4. CBC

    Time frame: 6, 12, and 24 months

    Serum level of WBC (ELISA)

  5. CRP

    Time frame: 6, 12, and 24 months

    Serum level of C-Reactive Protein (ELISA)

  6. albumin

    Time frame: 6, 12, and 24 months

    Serum level of albumin

  7. IL-6

    Time frame: 6, 12, and 24 months

    Serum level of Interleukin-6

  8. TNF-α

    Time frame: 6, 12, and 24 months

    Serum level of Tumor Necrosis Factor-alpha

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Research on the Construction of a Prognostic Model for COPD Complicated With Sarcopenic Obesity Based on Bioelectrical Impedance Phase Angle Technology

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2025
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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