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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04301245
Enrollment
201
Registered
2020-03-10
Start date
2020-02-28
Completion date
2020-04-10
Last updated
2020-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation

Keywords

Chronic Obstructive Pulmonary Disease, Pulmonary Rehabilitation, Education

Brief summary

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.

Interventions

OTHEREducational 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.

Sponsors

ADIR Association
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Anxiety and depression levelBaselineAnxiety and depression level assessed by the Hospital Anxiety and Depression scale will be analysed in logistic regression.
DyspneaBaselineDyspnea assessed by the modified Medical Research Council scale will be analysed in logistic regression.
6-Minute Stepper TestBaselineNumber of steps during the 6-Minute Stepper Test will be analysed in logistic regression.
6-Minute Walk TestBaselineDistance during the 6-Minute Walk Test will be analysed in logistic regression.
Maximal oxygen consumptionBaselineMaximal oxygen consumption during cardiopulmonary exercise testing will be analysed in logistic regression.
Maximal workloadBaselineMaximal workload achieved during cardiopulmonary exercise testing will be analysed in logistic regression.
Saint George's Respiratory QuestionnaireBaselineQuality of life assessed by Saint George's Respiratory Questionnaire will be analysed in logistic regression.
EmploymentBaselineEmployment will be analysed in logistic regression.
Educational levelBaselineEducational level assessed by the international classification Classification Internationale Type de l'Education will be analysed in logistic regression.
Cognitive impairmentBaselineCognitive impairment assessed by the Montreal Cognitive Assessment will be analysed in logistic regression.
HeightBaselineHeight will be analysed in logistic regression.
WeightBaselineWeight will be analysed in logistic regression.
Multiple logistic regression between the variables defined and the refusal of educational programBaselineThe variables are described below in primary outcomes
GenderBaselineGender will be analysed in logistic regression.
AgeBaselineAge will be analysed in logistic regression.
Body mass indexBaselineBody mass index will be analysed in logistic regression.
COPD stagesBaselineCOPD stages will be analysed in logistic regression.
Forced Expiratory Volume in one secondBaselineForced Expiratory Volume in one second will be analysed in logistic regression.
Forced Vital CapacityBaselineForced Vital Capacity will be analysed in logistic regression.
Ratio between Forced Expiratory Volume in one second and Forced Vital CapacityBaselineRatio between Forced Expiratory Volume in one second and Forced Vital Capacity will be analysed in logistic regression.
Total Lung CapacityBaselineTotal Lung Capacity will be analysed in logistic regression.
Residual VolumeBaselineResidual Volume will be analysed in logistic regression.
Diffusing capacity of the lungs for carbon monoxide divided by alveolar volumeBaselineDiffusing capacity of the lungs for carbon monoxide divided by alveolar volume will be analysed in logistic regression.
ComorbiditiesBaselineComorbidities will be analysed in logistic regression.
Tabacco statusBaselineTabacco status will be analysed in logistic regression.
Tabacco consumptionBaselineTabacco consumption will be analysed in logistic regression.
Prescription of oxygenBaselinePrescription of oxygen will be analysed in logistic regression.
Prescription of non invasive ventilationBaselinePrescription of non invasive ventilation will be analysed in logistic regression.
Arterial oxygen partial pressureBaselineArterial oxygen partial pressure will be analysed in logistic regression.
Arterial carbon dioxide partial pressureBaselineArterial carbone dioxide partial pressure will be analysed in logistic regression.
Location of the training sessionsBaselineLocation of the training sessions will be analysed in logistic regression.
Ambulance transportBaselineNumber of patients with an ambulance transport will be analysed in logistic regression.
Distance between patient's home and centerBaselineDistance between patient's home and center will be analysed in logistic regression.

Secondary

MeasureTime frameDescription
Attendance rate at educational sessions2 monthsAttendance rate at education sessions will be analysed
6-Minute Stepper Test2 monthsChange in number of steps during the 6-Minute Stepper Test will be compared between groups.
6-Minute Walk Test2 monthsChange in distance during the 6-Minute Walk Test will be compared between groups.
Saint George's Respiratory Questionnaire2 monthsChange in Saint George's Respiratory Questionnaire will be compared between groups.
Anxiety and depression level2 monthsAnxiety and depression level assessed by the Hospital Anxiety and Depression scale will be analysed in logistic regression.
Cognitive impairment2 monthsChange in cognitive impairment assessed by the Montreal Cognitive Assessment will be compared between groups.
Number of hospitalizations6 monthsNumber of hospitalizations will be compared between groups.
Number of hospitalized patients6 monthsNumber of hospitalized patients will be compared between groups.
Number of days of hospitalization6 monthsNumber of days of hospitalization will be compared between groups.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026