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临床试验/CTRI/2025/08/092938
CTRI/2025/08/092938
尚未招募
不适用

A STUDY TO ASSESS THE PREVALENCE OF SARCOPENIA AMONG SUBJECTS SUFFERING FROM CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) ATTENDING OUTDOOR DEPARTMENT AT A TERTIARY HEALTH CARE CENTRE OF NORTH INDIA

GSVM Medical College Kanpur1 个研究点 分布在 1 个国家目标入组 318 人开始时间: 2025年9月1日最近更新:

概览

阶段
不适用
状态
尚未招募
发起方
GSVM Medical College Kanpur
入组人数
318
试验地点
1
主要终点
Prevalence of Sarcopenia among subjects with COPD

概览

简要总结

Sarcopenia, a progressive loss of skeletal muscle mass, strength, and function, is increasingly recognised as a major comorbidity in patients with Chronic Obstructive Pulmonary Disease (COPD). Though commonly linked to ageing, sarcopenia often develops earlier in COPD due to chronic systemic inflammation, oxidative stress, physical inactivity, malnutrition, and prolonged corticosteroid use. It worsens respiratory function, limits exercise capacity, and leads to greater fatigue and physical inactivity, creating a vicious cycle of muscle degradation. These impairments result in loss of independence, social isolation, and psychological distress. Sarcopenic COPD patients consistently show poorer scores on quality-of-life. Sarcopenia increases morbidity by contributing to more frequent exacerbations, prolonged hospital stays, and higher readmission rates. The loss of both respiratory and peripheral muscle mass diminishes the ability to recover from illness, while balance impairment increases the risk of falls and fractures. Importantly, sarcopenia is an independent predictor of both all cause and COPD-specific mortality. Early identification and timely interventions such as nutritional supplementation and pulmonary rehabilitation can significantly reduce morbidity and mortality.

研究设计

研究类型
Observational

入排标准

年龄范围
40.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Subjects with diagnosis of COPD based on GOLD Guidelines 2025 and having severity of obstruction as GOLD 1-3 and belonging to GOLD Class A & B.
  • Haemoglobin level equal to or more than 8 g per dl Stable subjects with co-morbidities like diabetes (with HbA1c less than 10 percent hypertension with systolic BP less than140 and DBP less than 90 mm Hg hypothyroidism or hyperthyroidism with normal thyroid function on appropriate therapy CKD stage 1 and 2 Heart Failure NYHA class I and II will be eligible for participation.
  • They should be on stable dose for last at least three months.

排除标准

  • Acute on chronic exacerbation of COPD Presence of Cor Pulmonale History of hospitalization in last three months Malignancy CKD (stage greater than or equal to 3) Heart Failure (NYHA III or IV) COPD with severity of obstruction GOLD 4 and GOLD Stage E Neuromuscular disease (such as myasthenia gravis, MND) Stroke or other neurologic disorder with residual deficit Infections like HIV, active pulmonary or extrapulmonary TB Critical illness Organ transplant or immunosuppression Pregnancy or lactation Long term steroid use (except inhaled or topical) Bedridden subjects due to their inability in performing the required tests Subjects having locomotor abnormalities.

结局指标

主要结局

Prevalence of Sarcopenia among subjects with COPD

时间窗: Baseline

次要结局

  • Quality of life using SARQOL(Single)

研究者

发起方
GSVM Medical College Kanpur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Himanshu Maurya

KPS Post Graduate Institute of Medicine , GSVM Medical college kanpur

研究点 (1)

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