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| Name | Class |
|---|---|
| CHU de Rouen - Accueil | OTHER |
| Groupe Hospitalier du Havre | OTHER |
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Chronic obstructive pulmonary disease is a leading cause of mortality worldwide.
It is a systemic disease which includes pulmonary, cardiac, muscular, digestive and cognitive impairments.
Pulmonary rehabilitation is a symptomatic treatment to reduce dyspnea and functional incapacity. However, it effects on cognitive dysfunction are not well known.
The aim of this study is to assess the effects of a comprehensive pulmonary rehabilitation program on cognitive dysfunction in patients with severe to very severe chronic obstructive pulmonary disease using the Montreal Cognitive Assessment tool.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulmonary rehabilitation | The whole population will benefit from a comprehensive pulmonary rehabilitation program, including aerobic training, superior and inferior limb strength training, self-management and add-on to pulmonary rehabilitation as needed (i.e : electrical muscle stimulation, inspiratory muscle training, non-invasive ventilation, high flow nasal canula). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary rehabilitation | Other | See group description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline cognitive function | Cognitive function is assessed with the Montreal Cognitive Assessement tool | Cognitive function is assessed at the beginning of the rehabilitation program : day 0 |
| Cognitive function after pulmonary rehabilitation | Cognitive function is assessed with the Montreal Cognitive Assessement tool | Cognitive function is assessed at the end of the rehabilitation program : day 60 |
| Cognitive function : follow up | Cognitive function is assessed with the Montreal Cognitive Assessement tool | Cognitive function is assessed 3 month after rehabilitation : day 150 |
| Change in cognitive function from baseline to the end of pulmonary rehabilitation | Cognitive function is assessed with the Montreal Cognitive Assessement tool | Change in cognitive function from baseline to the end of pulmonary rehabilitation is assessed with end of pulmonary rehabilitation minus baseline values (day 60 - day 0) |
| Change in cognitive function from the end of pulmonary rehabilitation to 3 month of follow up | Cognitive function is assessed with the Montreal Cognitive Assessement tool | Change in cognitive function from the end of pulmonary rehabilitation to 3 month of follow up is assessed with the 3 month of follow minus the end of pulmonary rehabilitation values (day 150 - day 60) |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety and depression : baseline | Anxiety and depression are assessed with the Hospital Anxiety and Depression scale (HAD). | Anxiety and depression are assessed at the beginning of the rehabilitation program : day 0 |
| Anxiety and depression : end of pulmonary rehabilitation |
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Inclusion Criteria:
Non Inclusion Criteria:
Exclusion Criteria:
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Every patients with chronic obstructive pulmonary disease referred for pulmonary rehabilitation in ADIR Association (Rouen, France) and the Groupe Hospitalier du Havre (Le Havre, France) will be assessed for eligibility.
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| Name | Affiliation | Role |
|---|---|---|
| Cuvelier Antoine, Prof, PhD | CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France. | Principal Investigator |
| Muir Jean-François, Prof, PhD | CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; ADIR Association, Bois-Guillaume, France. | Study Chair |
| Tardif Catherine, MD | CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France | Study Chair |
| Viacroze Catherine, MD | CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France | Study Chair |
| Debeaumont David, MD | CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France. | Study Chair |
| Patout Maxime, MD | UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France | Study Chair |
| Lamia Bouchra, Prof, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bonnevie | Bois-Guillaume | 76230 | France | |||
| Médrinal |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Anxiety and depression are assessed with the Hospital Anxiety and Depression scale (HAD). |
| Anxiety and depression are assessed at the end of the rehabilitation program : day 60 |
| Anxiety and depression : follow up | Anxiety and depression are assessed with the Hospital Anxiety and Depression scale (HAD). | Anxiety and depression are assesses 3 month after the end of pulmonary rehabilitation program : day 150 |
| Quality of life : baseline | Quality of life is assessed using the Saint Georges Respiratory Questionnaire | Quality of life is assessed at the beginning of the rehabilitation program : day 0 |
| Quality of life : end of pulmonary rehabilitation | Quality of life is assessed using the Saint Georges Respiratory Questionnaire | Quality of life is assessed at the end of the rehabilitation program : day 60 |
| Quality of life : follow-up | Quality of life is assessed using the Saint Georges Respiratory Questionnaire | Quality of life is assessed 3 month after the end of the rehabilitation program : day 150 |
| Functional capacity (six-minute stepper test) : baseline | Functional capacity is assessed with the six-minute stepper test | Functional capacity is assessed at the beginning of the rehabilitation program : day 0 |
| Functional capacity (six-minute stepper test) : end of pulmonary rehabilitation | Functional capacity is assessed with the six-minute stepper test | Functional capacity is assessed at the end of the rehabilitation program : day 60 |
| Functional capacity (six-minute walk test) : baseline | Functional capacity is assessed with the six-minute walk test | Functional capacity is assessed at the beginning of the rehabilitation program : day 0 |
| Adherence | Adherence to the pulmonary rehabilitation program is assessed by the following equation : number of session performed divided by the number of scheduled sessions | Adherence is assessed at the end of the rehabilitation program : day 60 |
| Relation between the cognitive function and the respiratory function (forced expiratory volume in 1 second) | Cognitive function is assessed with the Montreal Cognitive Assessement tool and respiratory function is assessed with spirometric evaluation | The relation is assessed between baseline demographic data at day 0 |
| UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France ; Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France. |
| Study Chair |
| Quieffin Jean, MD | Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers. | Study Chair |
| Prieur Guillaume, PT, MsC | Service de pneumologie, Groupe Hospitalier du Havre, Fr | Study Chair |
| Médrinal Clément, PT, MsC | UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France. Service de réanimation, Groupe Hospitalier du Havre, France | Study Chair |
| Gravier Francis-Edouard, PT | ADIR Association, Bois-Guillaume, France | Study Chair |
| Bonnevie Tristan, PT, MsC | ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France. | Study Chair |
| Le Havre |
| 76600 |
| France |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |