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临床试验/NCT02190461
NCT02190461已完成不适用

Impact of Early Respiratory Rehabilitation in the Exacerbations of Re-admitted Patients With Chronic Obstructive Pulmonary Disease (COPD)

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2013年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
39
试验地点
2
主要终点
Exacerbations

研究概览

简要总结

Open clinical trial with 1 year follow up comparing the impact of an Early Respiratory Rehabilitation program with the conventional Respiratory Rehabilitation in COPD re-admitted patients. Outcomes will be exacerbations, symptoms, functional capacity and quality of life related to health (HRQOL).

详细描述

Open clinical trial with 1 year follow up comparing the impact of an Early Respiratory Rehabilitation (ERR) program with the conventional Respiratory Rehabilitation (CRR) in COPD re-admitted patients. Outcomes will be exacerbations, symptoms, functional capacity and quality of life related to health (HRQOL). Sixty patients will be randomized into the two groups: ERR starts the program during admission and continues at home immediately after discharge for a period of 3 months; CRR was started at home one month after discharge from hospital and continues for 3 months. Recruitment of patients and starting the RR program will occur in the first year. In the second year we will continue the intervention to those who have not completed the year. Follow-up will last until the completion of the year of all patients.

研究设计

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

入排标准

年龄范围
41 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age> 40 years
  • Diagnostic criteria of COPD GOLD II-IV confirmed by spirometry
  • Having frequent re-admissions (≥ 2 times / year).
  • Sign the informed consent.

排除标准

  • Have completed a pulmonary rehabilitation program (including training) in the last 6 months.
  • Respiratory and / or cardiac serious associated diseases.
  • End-stage COPD (inability to perform exercises or treatment with morphine).
  • Prognosis of <6 months.
  • Living in a residence or not having a primary caregiver.
  • Cognitive disorders that prevent active participation.
  • Patients who are admired to other hospitalization rooms than Pneumology.
  • Patients who do not belong to the area of health coverage of the Respiratory Rehabilitation home team

研究组 & 干预措施

Early Respiratory Rehabilitation

Experimental

Starting the Early Respiratory Rehabilitation programme during the admission and continues it at home immediately after discharge for a period of 3 months.

干预措施: Early Respiratory Rehabilitation Program (Procedure)

Conventional Respiratory Rehabilitation

Active Comparator

Started a conventional Respiratory Rehabilitation programme at home one month after discharge from hospital and continues for 3 months.

干预措施: Conventional Respiratory Rehabilitation Program (Procedure)

结局指标

主要结局

Exacerbations

时间窗: 1 year

Exacerbations with or without admission due to respiratory illness

次要结局

  • Functional capacity(1 year)
  • Dyspnea(1 year)
  • Quality of life related to health(1 year)

研究者

发起方
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
申办方类型
Other
责任方
Sponsor

研究点 (2)

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