NCT04301245|Completed
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Sponsor study identifier
observational
201
1 country
1
Study Start
February 28, 2020
Actual (reported)Primary Completion
March 31, 2020
Actual (reported)Study Completion
April 10, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 10, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 28, 2020
Actual (reported)March 6, 2020
Actual (reported)March 10, 2020
Actual (reported)March 31, 2020
Actual (reported)April 10, 2020
Actual (reported)Multiple logistic regression between the variables defined and the refusal of educational program
The variables are described below in primary outcomes
Baseline
Gender
Gender will be analysed in logistic regression.
Baseline
Age
Age will be analysed in logistic regression.
Baseline
Height
Height will be analysed in logistic regression.
Baseline
6-Minute Stepper Test
2 months
6-Minute Walk Test
2 months
Saint George's Respiratory Questionnaire
2 months
Anxiety and depression level
2 months
Cognitive impairment
2 months
Exercise Training and Educational Program (ETEP) group. Patients who accepted the educational program in addition to the exercise training.
Exercise Training (ET) group. Patients who refused the educational program and did only the exercise training.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients referred for pulmonary rehabilitation between July 2015 and July 2019 to ADIR Association, Rouen University Hospital, France
ADIR Association
Bois-Guillaume, France
Smondack P, Gravier FE, Combret Y, Muir JF, Cuvelier A, Debeaumont D, Medrinal C, Prieur G, Bonnevie T. Factors influencing participation in educational workshops as part of a pulmonary rehabilitation program in patients with chronic obstructive pulmonary disease: a retrospective study. Expert Rev Respir Med. 2022 Mar;16(3):341-349. doi: 10.1080/17476348.2022.1991793. Epub 2021 Nov 2.
Jean-François Muir, MD PhD
ADIR Association, Rouen University Hospital, Rouen, France;Normandie University, UNIROUEN, UPRES EA 3830, Rouen University Hospital, Haute-Normandie Research and Biomedical Innovation, Rouen, France
Antoine Cuvelier, MD PhD
Normandie University, Rouen University Hospital, Haute-Normandie Research and Biomedical Innovation, Rouen, France ; Pulmonary, Thoracic Oncology and Respiratory Intensive Care Department, Rouen University Hospital, Rouen, France.
David Debeaumont, MD
Department of Respiratory and Exercise Physiology and CICCRB 1404, Rouen University Hospital, Rouen France.
201 participants (actual enrollment reported by the registry).
First Submitted
March 6, 2020
First Posted
March 10, 2020
Study Start
February 28, 2020
Actual (reported)Comparison of the Cardiopulmonary and Gaz-exchange Response Between the Six-minute Stepper Test and the Incremental Cardiopulmonary Exercise Testing in Patients With Chronicle Obstructive Pulmonary Disease
Weight
Weight will be analysed in logistic regression.
Baseline
Body mass index
Body mass index will be analysed in logistic regression.
Baseline
COPD stages
COPD stages will be analysed in logistic regression.
Baseline
Forced Expiratory Volume in one second
Forced Expiratory Volume in one second will be analysed in logistic regression.
Baseline
Forced Vital Capacity
Forced Vital Capacity will be analysed in logistic regression.
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.
Baseline
Total Lung Capacity
Total Lung Capacity will be analysed in logistic regression.
Baseline
Residual Volume
Residual Volume will be analysed in logistic regression.
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.
Baseline
Comorbidities
Comorbidities will be analysed in logistic regression.
Baseline
Tabacco status
Tabacco status will be analysed in logistic regression.
Baseline
Tabacco consumption
Tabacco consumption will be analysed in logistic regression.
Baseline
Prescription of oxygen
Prescription of oxygen will be analysed in logistic regression.
Baseline
Prescription of non invasive ventilation
Prescription of non invasive ventilation will be analysed in logistic regression.
Baseline
Arterial oxygen partial pressure
Arterial oxygen partial pressure will be analysed in logistic regression.
Baseline
Arterial carbon dioxide partial pressure
Arterial carbone dioxide partial pressure will be analysed in logistic regression.
Baseline
Location of the training sessions
Location of the training sessions will be analysed in logistic regression.
Baseline
Ambulance transport
Number of patients with an ambulance transport will be analysed in logistic regression.
Baseline
Distance between patient's home and center
Distance between patient's home and center will be analysed in logistic regression.
Baseline
Dyspnea
Dyspnea assessed by the modified Medical Research Council scale will be analysed in logistic regression.
Baseline
6-Minute Stepper Test
Number of steps during the 6-Minute Stepper Test will be analysed in logistic regression.
Baseline
6-Minute Walk Test
Distance during the 6-Minute Walk Test will be analysed in logistic regression.
Baseline
Maximal oxygen consumption
Maximal oxygen consumption during cardiopulmonary exercise testing will be analysed in logistic regression.
Baseline
Maximal workload
Maximal workload achieved during cardiopulmonary exercise testing will be analysed in logistic regression.
Baseline
Saint George's Respiratory Questionnaire
Quality of life assessed by Saint George's Respiratory Questionnaire will be analysed in logistic regression.
Baseline
Employment
Employment will be analysed in logistic regression.
Baseline
Educational level
Educational level assessed by the international classification "Classification Internationale Type de l'Education" will be analysed in logistic regression.
Baseline
Cognitive impairment
Cognitive impairment assessed by the Montreal Cognitive Assessment will be analysed in logistic regression.
Baseline
Anxiety and depression level
Anxiety and depression level assessed by the Hospital Anxiety and Depression scale will be analysed in logistic regression.
Baseline
Contact the study team to confirm eligibility.
Tristan Bonnevie, PT MSc
ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, UNIROUEN, UPRES EA 3830, Rouen University Hospital, Haute- Normandie Research and Biomedical Innovation, Rouen, France.
Francis-Edouard Gravier, PT MSc
ADIR Association, Rouen University Hospital, Rouen, France ; Normandie University, UNIROUEN, UPRES EA 3830, Rouen University Hospital, Haute- Normandie Research and Biomedical Innovation, Rouen, France
Pauline Smondack, PT
ADIR Association, Rouen University Hospital, Rouen, France.
Primary Completion
March 31, 2020
Actual (reported)Study Completion
April 10, 2020
Actual (reported)Last Updated
June 1, 2020
Record last verified: 2020-05
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Source: ClinicalTrials.gov.
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