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临床试验/NCT04301245
NCT04301245已完成不适用

Profile of COPD Patients Refusing Educational Program in Pulmonary Rehabilitation and Impact on the Benefits

ADIR Association1 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2020年2月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
201
试验地点
1
主要终点
Weight

研究概览

简要总结

Pulmonary rehabilitation (PR) has proven its efficacy to improve dyspnea, health status, exercise tolerance and quality of life for patients with stable Chronic Obstructive Pulmonary Disease (COPD). Exercise training has previously been thoroughly studied but education has been less studied in PR. Furthermore, only few studies have investigated the added value of an educational program (EP) to exercise training on clinical and physical factors. Characterizing those patients who refuse EP is therefore a first step to better target them and potentially improve their adherence and outcome following PR.

The aim of this study was to determine the characteristics of the COPD patients referred to PR who refused EP compare to those who accepted and to identify the independent predictive factors of refusal. The investigators also sought to compare the change in clinical outcomes and number and length of hospitalization at six months following PR among those patients who accepted or not to participate in EP.

研究设计

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

入排标准

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

入选标准

  • Clinical diagnosis of COPD,
  • >18 years old,
  • Stable state of COPD.

排除标准

  • Patients who have not been offered an educational program
  • Patients who have already been offered an educational program during a pulmonary rehabilitation in the same center.

结局指标

主要结局

Weight

时间窗: Baseline

Weight will be analysed in logistic regression.

Total Lung Capacity

时间窗: Baseline

Total Lung Capacity will be analysed in logistic regression.

Diffusing capacity of the lungs for carbon monoxide divided by alveolar volume

时间窗: Baseline

Diffusing capacity of the lungs for carbon monoxide divided by alveolar volume will be analysed in logistic regression.

Prescription of oxygen

时间窗: Baseline

Prescription of oxygen will be analysed in logistic regression.

Anxiety and depression level

时间窗: Baseline

Anxiety and depression level assessed by the Hospital Anxiety and Depression scale will be analysed in logistic regression.

Height

时间窗: Baseline

Height will be analysed in logistic regression.

Multiple logistic regression between the variables defined and the refusal of educational program

时间窗: Baseline

The variables are described below in primary outcomes

Gender

时间窗: Baseline

Gender will be analysed in logistic regression.

Ratio between Forced Expiratory Volume in one second and Forced Vital Capacity

时间窗: Baseline

Ratio between Forced Expiratory Volume in one second and Forced Vital Capacity will be analysed in logistic regression.

Age

时间窗: Baseline

Age will be analysed in logistic regression.

COPD stages

时间窗: Baseline

COPD stages will be analysed in logistic regression.

Ambulance transport

时间窗: Baseline

Number of patients with an ambulance transport will be analysed in logistic regression.

Maximal oxygen consumption

时间窗: Baseline

Maximal oxygen consumption during cardiopulmonary exercise testing will be analysed in logistic regression.

Saint George's Respiratory Questionnaire

时间窗: Baseline

Quality of life assessed by Saint George's Respiratory Questionnaire will be analysed in logistic regression.

Body mass index

时间窗: Baseline

Body mass index will be analysed in logistic regression.

Forced Expiratory Volume in one second

时间窗: Baseline

Forced Expiratory Volume in one second will be analysed in logistic regression.

Forced Vital Capacity

时间窗: Baseline

Forced Vital Capacity will be analysed in logistic regression.

Residual Volume

时间窗: Baseline

Residual Volume will be analysed in logistic regression.

Comorbidities

时间窗: Baseline

Comorbidities will be analysed in logistic regression.

Tabacco status

时间窗: Baseline

Tabacco status will be analysed in logistic regression.

Tabacco consumption

时间窗: Baseline

Tabacco consumption will be analysed in logistic regression.

Prescription of non invasive ventilation

时间窗: Baseline

Prescription of non invasive ventilation will be analysed in logistic regression.

Dyspnea

时间窗: Baseline

Dyspnea assessed by the modified Medical Research Council scale will be analysed in logistic regression.

Employment

时间窗: Baseline

Employment will be analysed in logistic regression.

Arterial oxygen partial pressure

时间窗: Baseline

Arterial oxygen partial pressure will be analysed in logistic regression.

Arterial carbon dioxide partial pressure

时间窗: Baseline

Arterial carbone dioxide partial pressure will be analysed in logistic regression.

Maximal workload

时间窗: Baseline

Maximal workload achieved during cardiopulmonary exercise testing will be analysed in logistic regression.

Location of the training sessions

时间窗: Baseline

Location of the training sessions will be analysed in logistic regression.

Distance between patient's home and center

时间窗: Baseline

Distance between patient's home and center will be analysed in logistic regression.

6-Minute Stepper Test

时间窗: Baseline

Number of steps during the 6-Minute Stepper Test will be analysed in logistic regression.

Cognitive impairment

时间窗: Baseline

Cognitive impairment assessed by the Montreal Cognitive Assessment will be analysed in logistic regression.

6-Minute Walk Test

时间窗: Baseline

Distance during the 6-Minute Walk Test will be analysed in logistic regression.

Educational level

时间窗: Baseline

Educational level assessed by the international classification "Classification Internationale Type de l'Education" will be analysed in logistic regression.

次要结局

  • 6-Minute Walk Test(2 months)
  • Cognitive impairment(2 months)
  • Anxiety and depression level(2 months)
  • Number of hospitalizations(6 months)
  • Number of hospitalized patients(6 months)
  • Attendance rate at educational sessions(2 months)
  • Saint George's Respiratory Questionnaire(2 months)
  • 6-Minute Stepper Test(2 months)
  • Number of days of hospitalization(6 months)

研究者

发起方
ADIR Association
申办方类型
Other
责任方
Sponsor

研究点 (1)

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