Value of Early Intervention in Smokers with Preserved Ratio Impaired Spirometry(without comorbidities) with Pulmonary Rehabilitation and Smoking Cessation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- To identify smokers with PRIsm using spirometry to assess disease severity using MMRC grading,CAT score and spirometric classification of COPD and smoking index
研究概览
简要总结
The term PRIsm is characterized by decreased forced expiratory volume in one second (FEV1<80%) without airflow limitation (FEV1/FVC >0.7) The risk of COPD was increased in PRIsm patients. Several studies
shows association between PRIsm and Smokers. We divide the smokers into three groups based on spirometry results: normal, PRIsm, and COPD. Study design is based on Randomized control study. The reason for taking this study is COPD is said to be irreversible condition. My plan is to identify smokers with PRIsm and grade them in early COPD criteria and reverse the condition of one group by pulmonary
rehabilitation and smoking cessation and other group by placebo and counselling. Pulmonary rehabilitation is the most effective intervention for improving the quality of life and decreasing morbidity and mortality and its also cost effective tool. Smoking cessation also improves the quality of life by decreasing morbidity and mortality and also one of the effective intervention.The study is randomized controlled parallel trial arms to determine smoking cessation and pulmonary rehab in parallel part whereas placebo and counselling in control part. Total of 142 patients will be randomized into two groups using computer generated randomization that control group(n=71) and parallel group which will consist of smoking cessation and pulmonary rehab(n=71) and assesor outcome will be blinded to group allocation. Intervention group will receive pulmonary rehab including breathing exercises,upper limb exercises,lower exercises and mixed exercises and also they will receive validated education booklet , videos and dairy to note daily exercises. Whereas control group will receive placebo and counselling.Outcome will be assesed at baseline,2nd month,4th month,6th month,8th month,10th month and 12th month(end of intervention)
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 25.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Both Male and Female Patients who have access to smart phones with internet Patients who are smokers with COPD Patients who have abnormality in spirometry such as PRIsm.
排除标准
- •Patients who are less than 25 years Patients who dont have respiratory symptoms Patients with normal spirometry Patients who dont have Chest X ray abnormalities.
结局指标
主要结局
To identify smokers with PRIsm using spirometry to assess disease severity using MMRC grading,CAT score and spirometric classification of COPD and smoking index
时间窗: Baseline and at 2nd month,4th month,6th month,8th month,10th month and 12th month
次要结局
- To intervene with smoking cessation and pulmonary rehabilitation to improve the quality of life and also treat another group with placebo and counselling to improve the quality of life(Frequent followup of patients upto 12 months)
研究者
Dr Arunan P
Chettinad Hospital and Research Institute