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临床试验/NCT02512549
NCT02512549已完成不适用

'Effects of Structured Outpatient Pulmonary Rehabilitation Intervention on Exercise Capacity and Quality of Life in Patients With Severe Chronic Obstructive Pulmonary Disease: A Randomized Controlled Study'

All India Institute of Medical Sciences, New Delhi2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2015年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
2
主要终点
To assess the change in Six Minute Walk Distance in experimental arm

研究概览

简要总结

This study is a randomized parallel group controlled trial which aims to study the effects of pulmonary rehabilitation intervention on exercise capacity and quality of life in patients with severe COPD as compared to standard medical care. The expected duration is one and a half years with effect from 1st July, 2015 and will include 80 patients, 40 in each arm.

详细描述

Chronic obstructive pulmonary disease ranks among the top five causes of unnatural deaths in India and its prevalence continues to increase. Widespread habit of smoking and the use of biomass fuels have led to such a high prevalence of COPD. The loss of physical capacity and the adverse psychosocial effects of the disorder contribute greatly to morbidity and mortality. Medicines have a limited role in improving the lung functions and physical capacity in patients with COPD. Pulmonary rehabilitation (PR) aims to return the patient with chronic obstructive pulmonary disease (COPD) to the highest level of independent functioning. This is achieved by providing individually tailored exercise training schedules, education and psychosocial support.

Pulmonary Rehabilitation has been defined by the American and the European Thoracic Societies as "a comprehensive intervention based on a thorough patient assessment followed by patient tailored therapies that include, but are not limited to, exercise training, education, and behavior change, designed to improve the physical and psychological condition of people with chronic respiratory disease and to promote the long-term adherence to health-enhancing behaviors." COPD is now considered a multi-systemic disease with frequent co-morbidities and hence the optimal management of this complex group of patients requires integrated care principles, pulmonary rehabilitation being the core component.

Patients with chronic obstructive pulmonary disease (COPD) often decrease their physical activity because exercise can worsen dyspnea. The progressive deconditioning associated with inactivity initiates a vicious cycle, with dyspnea becoming problematic at ever lower physical demands. Pulmonary rehabilitation aims to break the cycle. Benefits of pulmonary rehabilitation include decreased dyspnea, improved health-related quality of life, fewer days of hospitalization, and decreased health-care utilization.

As yet, there are no controlled studies on the use and effectiveness of pulmonary rehabilitation in the Indian setting and the optimum training regimen. This study aims to look at any improvements in the exercise capacity by means of objective incremental and field exercise tests, quality of life using validated questionnaires, severity of dyspnea, lung functions and nutritional parameters in patients who are diagnosed with severe forms of COPD after they have undergone a structured exercise training program.

Primary Objective • To assess the effect of structured outpatient pulmonary rehabilitation intervention on the six minute walk distance and health related quality of life in patients with chronic obstructive pulmonary disease.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
15 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with moderate to severe COPD based on spirometry (FEV1: <50%) presenting to pulmonary medicine outpatient clinic with mMRC grade 1 to
  • Those who are willing to participate in the study

排除标准

  • Patients on long term oxygen therapy or candidates for long term oxygen therapy
  • Patients with severe orthopedic or neurological disorders limiting their mobility
  • Exercise induced syncope
  • Unstable angina or recent MI (within 4 months)
  • Diagnosed Cognitive or active psychiatric disorders
  • Co morbidities: uncontrolled hypertension >180/100
  • Recent hospitalization for exacerbation within 6 weeks

结局指标

主要结局

To assess the change in Six Minute Walk Distance in experimental arm

时间窗: 2 months

Exercise Capacity as measured by six minutes walk distance

To assess the change in health related quality of life in experimental arm (Saint George Respiratory Questionnaire)

时间窗: 2 months

Quality of life will be assessed by Saint George Respiratory Questionnaire

次要结局

  • Maximum exercise capacity(2 months)
  • BODE index(2 months)
  • Lung Functions(2 months)
  • Anxiety and Depression scale(2 months)

研究者

发起方
All India Institute of Medical Sciences, New Delhi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Raju Prasad Pangeni

DM Senior Resident, Department of Pulmonary Medicine and Sleep Disorders

All India Institute of Medical Sciences, New Delhi

研究点 (2)

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