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临床试验/NCT01195402
NCT01195402已完成不适用

Low Intensity Pulmonary Outpatient Rehabilitation in Moderate to Severe COPD

Universitätsklinikum Hamburg-Eppendorf2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2004年4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
100
试验地点
2
主要终点
6-Minute walk distance

研究概览

简要总结

This randomised-controlled study is undertaken to investigate the effects of a long term low intensity outpatient training program on physical fitness and quality of life in moderate to severe COPD patients.

详细描述

Broad evidence exists on the beneficial effects of pulmonary rehabilitation on exercise capabilities and quality of life in COPD patients. Clinically relevant effects have been achieved by training programs of differing design regarding setting (inpatient vs. outpatient vs. home-based), duration (short-term vs. long-term) and intensity (high vs. low intensity).

While there is sufficient evidence to propose pulmonary rehabilitation its use is generally low in clinical practice. One reason may be that it is unlikely that costly programs are offered to a significant proportion of eligible patients. The ideal training program will therefore at the same time accomplish the greatest improvements regarding physical capabilities and quality of life and sustain them for the longest period at the lowest cost.

The purpose of the present study is to evaluate whether a continuous, low-intensity, low-cost, physiotherapist-led outpatient pulmonary rehabilitation program is a able to achieve significant long-term improvements of exercise tolerance and quality of life in moderate to severe COPD patients at a lower cost level than previously published programs.

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
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COPD GOLD stage II-IV
  • smoking history of >20 pack years
  • adequate pharmacological therapy
  • written informed consent

排除标准

  • respiratory insufficiency, defined as PaO2<55 mm Hg and/or PaCO2>50 mm Hg breathing room air
  • manifest cardiac insufficiency
  • uncontrolled arterial hypertension
  • malignant disease
  • symptomatic coronary heart disease resp. pathological cycle ergometry results
  • limited physical capabilities caused by musculoskeletal disorders
  • unwillingness to return for follow-up
  • previous or ongoing participation in exercise training programs
  • unability to attend at least 75% of sessions

结局指标

主要结局

6-Minute walk distance

时间窗: Six months

次要结局

  • Quality of life(Six months)
  • Maximum oxygen uptake(Six months)

研究者

申办方类型
Other

研究点 (2)

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