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

NCT07136246 | Completed DMC

• 1 other identifier: COSAT
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenic Obesity; COPD

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (8)

• Acute exacerbations

  6, 12, and 24 months

• Hospitalizations

  6, 12, and 24 months

• Mortality

  24 months

• CBC

  6, 12, and 24 months

• CRP

  6, 12, and 24 months

Study Arms (2)

COPD with sarcopenic obesity

COPD with sarcopenic obesity based on Bioelectrical Impedance Phase Angle Technology by the enrollment

Device: InBody S10

COPD without sarcopenic obesity

COPD without sarcopenic obesity based on Bioelectrical Impedance Phase Angle Technology by the enrollment

Device: InBody S10

Interventions

InBody S10 DEVICE

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

COPD with sarcopenic obesity; COPD without sarcopenic obesity

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The elderly COPD patients measured with bioelectrical impedance phase angle technology

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Huadong hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yinggang Zhu, MD, PhD

  Huadong Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hospital director

Study Record Dates

• First Submitted: June 29, 2025
• First Posted: August 22, 2025
• Study Start: August 1, 2025
• Primary Completion: January 23, 2026
• Study Completion: January 23, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)