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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Rehabilitation
• Intervention / Treatment: Other: Educational program

• Study Type: Observational
• Enrollment (Actual): 201

Contacts and Locations

Study Locations

• France
  • Bois-Guillaume, France
    • ADIR Association

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients referred for pulmonary rehabilitation between July 2015 and July 2019 to ADIR Association, Rouen University Hospital, France

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ETEP group; Exercise Training and Educational Program (ETEP) group. Patients who accepted the educational program in addition to 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.
ET group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-Minute Stepper Test	Change in number of steps during the 6-Minute Stepper Test will be compared between groups.	2 months
6-Minute Walk Test	Change in distance during the 6-Minute Walk Test will be compared between groups.	2 months
Saint George's Respiratory Questionnaire	Change in Saint George's Respiratory Questionnaire will be compared between groups.	2 months
Anxiety and depression level	Anxiety and depression level assessed by the Hospital Anxiety and Depression scale will be analysed in logistic regression.	2 months
Cognitive impairment	Change in cognitive impairment assessed by the Montreal Cognitive Assessment will be compared between groups.	2 months
Number of hospitalizations	Number of hospitalizations will be compared between groups.	6 months
Number of hospitalized patients	Number of hospitalized patients will be compared between groups.	6 months
Number of days of hospitalization	Number of days of hospitalization will be compared between groups.	6 months
Attendance rate at educational sessions	Attendance rate at education sessions will be analysed	2 months

Collaborators and Investigators

• Sponsor: ADIR Association
• Investigators: Principal Investigator: 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; Study Chair: 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.; Study Chair: David Debeaumont, MD, Department of Respiratory and Exercise Physiology and CICCRB 1404, Rouen University Hospital, Rouen France.; Study Chair: 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.; Study Chair: 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; Study Chair: Pauline Smondack, PT, ADIR Association, Rouen University Hospital, Rouen, France.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2020
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): April 10, 2020

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2020
• Last Update Submitted That Met QC Criteria: May 29, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Pulmonary Rehabilitation; Chronic Obstructive Pulmonary Disease; Education
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: RETRO-ETP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No