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临床试验/CTRI/2025/01/079833
CTRI/2025/01/079833尚未招募不适用

Predictors of Severe Exacerbation in Chronic Obstructive Pulmonary Disease Patients

Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2025年2月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
102
试验地点
1
主要终点
Respiratory Muscle Strength

研究概览

简要总结

Objective: To investigate the predictive ability of respiratory muscle strength, functional capacity, pulmonary function, and arterial blood gas analysis for severe exacerbation in patients with COPD.

Study Design: The study will employ a retrospective, cross-sectional study design.

Sample: Retrospective data will be taken from Metro Hospitals and Heart Institute, Noida, India.

Sample size: The total sample size for the present trial will be 102.

Independent Variable:

Respiratory Muscle Strength

Functional Capacity

Pulmonary Lung Tests

Arterial Blood Gas Analysis

Dependent Variable: Severe acute exacerbation of COPD (AECOPD)

Covariates Adjustment will be done.

Statistical Analysis: Regression analysis.

研究设计

研究类型
Observational

入排标准

年龄范围
40.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Age is 40 years to 80 years.
  • Sex is Males and Females.
  • Participants had a clinical diagnosis of COPD confirmed by spirometry value FEV1/FVC less than 0.70 and a grade II, III, or IV airflow limitation according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.
  • The grades of the COPD classified as moderate GOLD Stage II where FEV1 greater than or equal to 50% predicted but less than 80% predicted, severe GOLD Stage III where FEV1 is greater than or equal to 30% predicted but less than 50% predicted, very severe GOLD Stage IV where FEV1 is less than 30% predicted.
  • Patients who are hospitalised for severe exacerbation of COPD experience worsening symptoms for a duration of less than 2 weeks.

排除标准

  • Patients with additional active inflammatory diseases such as Rheumatoid Arthritis, Systemic Lupus Erythematous, Fibromyalgia, and Inflammatory Bowel Syndrome.
  • The patient presented with Myopathy.
  • Patients with other obstructive pulmonary diseases such as Asthma, Asthma-COPD Overlap Syndrome (ACOS).
  • Patient who had Unstable Angina and Acute Myocardial Infraction.

结局指标

主要结局

Respiratory Muscle Strength

时间窗: At Baseline

次要结局

  • Six-Minute Walk Tests (6-MWT)

研究者

发起方
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Mahima mayee Tripathy

Jamia Millia Islamia

研究点 (1)

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