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临床试验/NCT01107028
NCT01107028已完成不适用

Pulmonary Rehabilitation for Idiopathic Pulmonary Fibrosis

National Jewish Health1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2010年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
1
主要终点
Six-minute walk distance

研究概览

简要总结

Idiopathic pulmonary fibrosis (IPF) is a devastating disease marked by progressive lung scarring leading to multiple life-altering sequelae. The over-arching goals of the principal investigator's research program are to more fully characterize these sequelae and to examine interventions that might improve them. The hypotheses of this particular study are that pulmonary rehabilitation (PR) is one such intervention, and that PR will improve the sequelae of dyspnea and impairments in functional capacity, cognition, mood and anxiety, fatigue, and quality of life (QOL) in patients with IPF.

详细描述

Subjects will come to our center to be enrolled. Baseline data collection (performance of a six-minute walk test and completion of questionnaires) and randomization to one of two groups--either Rehab or Wait--will take place at the same enrollment visit if time permits. Subjects in either group will complete pulmonary rehabilitation, just at slightly different times, depending on which group they are randomized to.

Pulmonary rehabilitation is a program run by respiratory and/or physical therapists and other health professionals that involves exercise, education, and support with the goals to improve functional capacity, symptom management, and well-being. It will last 6-8 weeks, during which time, subjects will complete 18 approximately hour-long sessions. Pulmonary rehabilitation may be completed at any local center that makes travel convenient.

Data collection visits will take place at National Jewish Health at baseline, eight weeks (without intervening pulmonary rehabilitation in the Wait group), after completion of pulmonary rehabilitation (time varies, depending on the randomization group), and finally six months after completion of the pulmonary rehabilitation program.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Age > 40 years
  • Able to walk unassisted for balance
  • Able to speak and understand English well enough to complete complex tasks with directions given in English

排除标准

  • Pulmonary fibrosis not due to IPF
  • Coexisting comorbid conditions that would make exercise contraindicated

结局指标

主要结局

Six-minute walk distance

时间窗: Eight weeks

Distance walked during a standard six-minute walk test.

次要结局

  • Six minute walk distance(Six months after completion of pulmonary rehabilitation)
  • dyspnea, fatigue, anxiety, depression, quality of life(Six months after completion of pulmonary rehabilitation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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