Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Other: Pulmonary rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18years; Chronic obstructive pulmonary disease stade III to IV; Referred for pulmonary rehabilitation. Non Inclusion Criteria: Pregnancy or likely to be; History of psychiatric, neuro-vascular, cognitive disease or cranial trauma; Active alcoholism; Guardianship; Hospitalisation for acute exacerbation of chronic obstructive pulmonary disease in the previous 4 weeks; Exclusion Criteria: Interruption of the pulmonary rehabilitation program > 15 days; Disruption of the training before the 18th session; Less than 18 sessions in four month.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pulmonary rehabilitation<br>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). | Other: Pulmonary rehabilitation<br>* See group description.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |