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Long Term Evaluation of Activity Levels Post Pulmonary Rehabilitation

2012年2月9日 更新者:Professor Richard Costello、Beaumont Hospital

Long Term Evaluation of Activity Levels Post Pulmonary Rehabilitation: 1 Year Follow-up

Sustained improvement after pulmonary rehabilitation in activity levels as measured by an activity armband.

Pulmonary rehabilitation is utilized to improve exercise capacity, quality of life and prognosis for patients who suffer from chronic obstructive pulmonary disease. There is also strong evidence that supports the use of pulmonary rehabilitation to decrease hospital admissions thereby reducing cost of care. Recent studies suggest that the significant benefits achieved through rehabilitation fade with time and that in order to improve activities of daily living; for example, average daily number of steps, programmes of longer duration are required.

The primary aim of this study is to identify objective sustained improved in activity levels using the SenseWear activity armband after a short-term pulmonary rehabilitation programme. Secondary aims are to determine antibiotic and steroid use pre and post rehabilitation.

研究概览

详细说明

Chronic obstructive pulmonary disease (COPD) is characterised by airflow limitation and by both systemic and airway inflammation. Together these features lead to decreased physical activity which in turn worsens the patient's dyspnoea. In patients with COPD, physical activity levels are low compared to healthy controls and indeed lower than in patients with other chronic conditions such as arthritis and diabetes. For patients with COPD, decreased physical activity and breathlessness are significant predictors of mortality and morbidity. By reversing deconditioning pulmonary rehabilitation using supervised and home exercise programs leads to increased exercise capacity and health quality of life scores. In order for the benefits of pulmonary rehabilitation to be sustained in the long-term it is essential that there is a change in the patient's physical activity in their home life. While practice guidelines recommend that there is transference of exercise to the home setting it is unknown if this happens in reality. Addressing whether there is an increase in physical activity at home after pulmonary rehabilitation is the focus of this study.

Physical activity can be measured in a number of ways, including direct observation, patient diaries and questionnaires, but one of the most successful are the performance based motion sensors such as pedometers and accelerometers. One such performance based motion sensor is the SenseWear accelerometer. The SenseWear has previously been used in patients with COPD, has been shown to be a reliable measure of physical activity performed in this population, other than those using rolators and it is objectively more accurate than questionnaires and diaries. The hypothesis of this study was that pulmonary rehabilitation leads to a sustained improvement in physical activity in patients with COPD. Physical activity was measured by the daily averaged activity recorded with a SenseWear armband at several time points in the year after a course of pulmonary rehabilitation.

研究类型

介入性

注册 (实际的)

65

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Dublin
      • Beaumont、Dublin、爱尔兰、9
        • Beaumont Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

35年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • A diagnosis of COPD based on the GOLD staging of the disease
  • Referred to pulmonary rehabilitation by a respiratory consultant or member of the COPD Team
  • Modified Medical Research Council Score of 3 or above
  • Ability to mobilize independently
  • Motivated to exercise independently

Exclusion Criteria:

  • No evidence of COPD on spirometry
  • Acute exacerbation within the last 4-6 weeks
  • Evidence of ischemic heart disease/acute changes on ECG
  • Uncontrolled hypertension
  • Insulin dependent diabetes mellitus
  • Inability to exercise independently or musculoskeletal/neurological conditions which would prevent completion of the course
  • Lung cancer previous attendance at pulmonary rehabilitation

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
无干预:Control Group
Patients are randomized to the control group and are assessed pre rehabilitation and post rehabilitation after which they proceed to the intervention group.
实验性的:Pulmonary Rehabilitation
Patients undergo an active seven week pulmonary rehabilitation programme. Assessments occur pre rehabilitation, post rehabilitation, at three months and at one year.
Patients undergo pulmonary rehabilitation for two hours twice a week for seven weeks. The first hour comprises of an individualized exercise programme and the second hour consists of an educational component. Patients are also required to undergo inspiratory muscle training five days a week for thirty minutes and exercise for an additional three days a week for thirty minutes.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Sustained improvement in free-living activities, measured as the average daily METs
大体时间:At the end of 1 year compared to baseline
Using an accelerometer, which will be worn by patients for seven consecutive days at each time frame, daily average measurements of the number of steps per day, total energy expenditure and METs that will be broken down into sedentary, moderate and vigorous, plus sleep time and efficiency.
At the end of 1 year compared to baseline

次要结果测量

结果测量
措施说明
大体时间
Quality of Life
大体时间:baseline will be compared to that at 1 year follow-up
Two quality of life questionnaires will be utilized, 1) the St. Georges Disease Questionnaire; a disease specific questionnaire, 2)The generic EuroQol questionnaire
baseline will be compared to that at 1 year follow-up
The Incremental Shuttle Walk Test
大体时间:baseline will be compared to that at 1 year follow-up
This is a validated field exercise test used to prescribe exercise intensity and determine functional capacity
baseline will be compared to that at 1 year follow-up
The Modified Medical Research Council Scale
大体时间:baseline will be compared to that at 1 year follow-up
This questionnaire measures breathlessness on activity
baseline will be compared to that at 1 year follow-up
Pulmonary Function Tests
大体时间:baseline will be compared to that at 1 year follow-up
Measurements of forced expiratory volume in 1 second, Forced Vital Capacity, Inspiratory Capacity and peak inspiratory muscle pressure will all be measured
baseline will be compared to that at 1 year follow-up
Borg Score
大体时间:baseline will be compared to that at 1 year follow-up
A 10 point scale measurement of breathlessness
baseline will be compared to that at 1 year follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Richard W Costello, Professor、Beaumont Hospital
  • 首席研究员:Brenda M Deering, MSc Physio、Beaumont Hospital
  • 首席研究员:Claire Egan, MSc Physio、Beaumont Hospital
  • 首席研究员:Niamh M McCormack, MSc Nursing、Beaumont Hosptial

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2007年6月1日

初级完成 (实际的)

2010年7月1日

研究完成 (实际的)

2010年7月1日

研究注册日期

首次提交

2010年8月18日

首先提交符合 QC 标准的

2012年2月9日

首次发布 (估计)

2012年2月10日

研究记录更新

最后更新发布 (估计)

2012年2月10日

上次提交的符合 QC 标准的更新

2012年2月9日

最后验证

2012年2月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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