An observational study in Chronic Obstructive Pulmonary Disease and Pulmonary Rehabilitation, sponsored by ADIR Association. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-01.
Sponsored by ADIR Association · Observational
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 201 is above the median of 157 across 929 observational studies indexed under Lung Diseases.
Browse Lung Diseases studies →ADIR Association is the lead sponsor of 26 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients referred for pulmonary rehabilitation between July 2015 and July 2019 to ADIR Association, Rouen University Hospital, France
Exclusion Criteria:
Exercise Training and Educational Program (ETEP) group. Patients who accepted the educational program in addition to the exercise training.
Other: Educational program
Exercise Training (ET) group. Patients who refused the educational program and did only the exercise training.
Other: Educational program
The educational program (EP) was offered during the initial session of the pulmonary rehabilitation. According to the french law, patients were free to participate or not. The EP consisted of an educational diagnosis, educational workshops and an individual final assessment.
Multiple logistic regression between the variables defined and the refusal of educational program
The variables are described below in primary outcomes
Time frame: Baseline
Gender
Gender will be analysed in logistic regression.
Time frame: Baseline
Age
Age will be analysed in logistic regression.
Time frame: Baseline
Height
Height will be analysed in logistic regression.
Time frame: Baseline
Weight
Weight will be analysed in logistic regression.
Time frame: Baseline
Body mass index
Body mass index will be analysed in logistic regression.
Time frame: Baseline
COPD stages
COPD stages will be analysed in logistic regression.
Time frame: Baseline
Forced Expiratory Volume in one second
Forced Expiratory Volume in one second will be analysed in logistic regression.
Time frame: Baseline
Forced Vital Capacity
Forced Vital Capacity will be analysed in logistic regression.
Time frame: Baseline
Ratio between Forced Expiratory Volume in one second and Forced Vital Capacity
Ratio between Forced Expiratory Volume in one second and Forced Vital Capacity will be analysed in logistic regression.
Time frame: Baseline
Total Lung Capacity
Total Lung Capacity will be analysed in logistic regression.
Time frame: Baseline
Residual Volume
Residual Volume will be analysed in logistic regression.
Time frame: Baseline
Diffusing capacity of the lungs for carbon monoxide divided by alveolar volume
Diffusing capacity of the lungs for carbon monoxide divided by alveolar volume will be analysed in logistic regression.
Time frame: Baseline
Comorbidities
Comorbidities will be analysed in logistic regression.
Time frame: Baseline
Tabacco status
Tabacco status will be analysed in logistic regression.
Time frame: Baseline
Tabacco consumption
Tabacco consumption will be analysed in logistic regression.
Time frame: Baseline
Prescription of oxygen
Prescription of oxygen will be analysed in logistic regression.
Time frame: Baseline
Prescription of non invasive ventilation
Prescription of non invasive ventilation will be analysed in logistic regression.
Time frame: Baseline
Arterial oxygen partial pressure
Arterial oxygen partial pressure will be analysed in logistic regression.
Time frame: Baseline
Arterial carbon dioxide partial pressure
Arterial carbone dioxide partial pressure will be analysed in logistic regression.
Time frame: Baseline
Location of the training sessions
Location of the training sessions will be analysed in logistic regression.
Time frame: Baseline
Ambulance transport
Number of patients with an ambulance transport will be analysed in logistic regression.
Time frame: Baseline
Distance between patient's home and center
Distance between patient's home and center will be analysed in logistic regression.
Time frame: Baseline
Dyspnea
Dyspnea assessed by the modified Medical Research Council scale will be analysed in logistic regression.
Time frame: Baseline
6-Minute Stepper Test
Number of steps during the 6-Minute Stepper Test will be analysed in logistic regression.
Time frame: Baseline
6-Minute Walk Test
Distance during the 6-Minute Walk Test will be analysed in logistic regression.
Time frame: Baseline
Maximal oxygen consumption
Maximal oxygen consumption during cardiopulmonary exercise testing will be analysed in logistic regression.
Time frame: Baseline
Maximal workload
Maximal workload achieved during cardiopulmonary exercise testing will be analysed in logistic regression.
Time frame: Baseline
Saint George's Respiratory Questionnaire
Quality of life assessed by Saint George's Respiratory Questionnaire will be analysed in logistic regression.
Time frame: Baseline
Employment
Employment will be analysed in logistic regression.
Time frame: Baseline
Educational level
Educational level assessed by the international classification "Classification Internationale Type de l'Education" will be analysed in logistic regression.
Time frame: Baseline
Cognitive impairment
Cognitive impairment assessed by the Montreal Cognitive Assessment will be analysed in logistic regression.
Time frame: Baseline
Anxiety and depression level
Anxiety and depression level assessed by the Hospital Anxiety and Depression scale will be analysed in logistic regression.
Time frame: Baseline
6-Minute Stepper Test
Change in number of steps during the 6-Minute Stepper Test will be compared between groups.
Time frame: 2 months
6-Minute Walk Test
Change in distance during the 6-Minute Walk Test will be compared between groups.
Time frame: 2 months
Saint George's Respiratory Questionnaire
Change in Saint George's Respiratory Questionnaire will be compared between groups.
Time frame: 2 months
Anxiety and depression level
Anxiety and depression level assessed by the Hospital Anxiety and Depression scale will be analysed in logistic regression.
Time frame: 2 months
Cognitive impairment
Change in cognitive impairment assessed by the Montreal Cognitive Assessment will be compared between groups.
Time frame: 2 months
Number of hospitalizations
Number of hospitalizations will be compared between groups.
Time frame: 6 months
Number of hospitalized patients
Number of hospitalized patients will be compared between groups.
Time frame: 6 months
Number of days of hospitalization
Number of days of hospitalization will be compared between groups.
Time frame: 6 months
Attendance rate at educational sessions
Attendance rate at education sessions will be analysed
Time frame: 2 months
Plan to share: No
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
ADIR Association