跳至主要内容
临床试验/NCT03542318
NCT03542318已完成不适用

Effects of a Pulmonary Rehabilitation Programme on Functional and Health Status Measures in Patients With Pulmonary Fibrosis

University of Malta1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
6 minute walk test

研究概览

简要总结

The inclusion of Pulmonary Rehabilitation (PR) as part of the management of pulmonary fibrosis although being highly recommended and recommended in guidelines still sees studies exploring the outcomes from such an intervention limited. The present study aims to contribute to the available literature by investigating the effects of a high intensity, 12week PR programme on functional and quality of life measures in patients with a diagnosis of pulmonary fibrosis.

详细描述

The inclusion of Pulmonary Rehabilitation (PR) as part of the management of pulmonary fibrosis although being highly recommended and recommended in guidelines still sees studies exploring the outcomes from such an intervention limited. The present study aims to contribute to the available literature by investigating the effects of a high intensity, 12week PR programme on functional and quality of life measures in patients with a diagnosis of pulmonary fibrosis. This study reports outcomes of an observational, quasi experimental type of study. A total of 120 participants were recruited: 60 patients formed part of the active group, another 60 patients were enrolled in an inactive group. Each participant was classified according to the modified Medical Research Council dyspnoea scale and placed in one of 5 categories (0 to 4) according to self-perceived breathlessness during daily activities. The following outcomes were measured: Lung function tests including plethysmography and diffusion capacity of carbon monoxide (DLCO), functional tests (6-minute walking test, Dyspnoea Borg Scale) and Health status measures (St George's Respiratory Questionnaire and HAD score).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Patients with a confirmed diagnosis of Pulmonary Fibrosis
  • Patients had to be medically stable to participate in such a programme

排除标准

  • Any orthopaedic or neurological condition affecting mobility
  • If they required oxygen therapy this had to be used

结局指标

主要结局

6 minute walk test

时间窗: The 6MWD shall be measures at baseline and on completion of the programme at 12weeks

The six-minute walking distance test (6MWD) was performed according to the American Thoracic Society guidelines (ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories 2002). Each patient was instructed to walk as rapidly as possible in a 30-meter corridor for the time of this test. The test was repeated twice with an interval of 30 minutes. The longest distance on a 6MWT and oxygen saturation were utilized to measure exercise capacity. Dyspnoea was scored using the Borg Category Ratio Scale (Borg 1982) measuring dyspnoea symptoms before and after the test.

次要结局

  • Hospital Anxiety and Depression score(This outcome shall be measured at baseline and on completion of the PR programme at 12weeks)
  • St George's Respiratory Questionnaire(This outcome shall be measured at baseline and on completion of the PR programme at 12weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anabel Sciriha

Principal Investigator

University of Malta

研究点 (1)

Loading locations...

相似试验

Effects of Pulmonary Rehabilitation on Functional... | 临床试验