Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Obstructive Pulmonary Disease
- Sponsor
- ADIR Association
- Enrollment
- 56
- Locations
- 2
- Primary Endpoint
- Baseline cognitive function
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Baseline cognitive function
Time Frame: Cognitive function is assessed at the beginning of the rehabilitation program : day 0
Cognitive function is assessed with the Montreal Cognitive Assessement tool
Cognitive function after pulmonary rehabilitation
Time Frame: Cognitive function is assessed at the end of the rehabilitation program : day 60
Cognitive function is assessed with the Montreal Cognitive Assessement tool
Cognitive function : follow up
Time Frame: Cognitive function is assessed 3 month after rehabilitation : day 150
Cognitive function is assessed with the Montreal Cognitive Assessement tool
Change in cognitive function from baseline to the end of pulmonary rehabilitation
Time Frame: 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)
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
Time Frame: 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)
Cognitive function is assessed with the Montreal Cognitive Assessement tool
Secondary Outcomes
- Functional capacity (six-minute stepper test) : baseline(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 at the end of the rehabilitation program : day 60)
- Anxiety and depression : end of pulmonary rehabilitation(Anxiety and depression are assessed at the end of the rehabilitation program : day 60)
- Quality of life : end of pulmonary rehabilitation(Quality of life is assessed at the end of the rehabilitation program : day 60)
- Quality of life : follow-up(Quality of life is assessed 3 month after the end of the rehabilitation program : day 150)
- Anxiety and depression : baseline(Anxiety and depression are assessed at the beginning of the rehabilitation program : day 0)
- Anxiety and depression : follow up(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 at the beginning of the rehabilitation program : day 0)
- Functional capacity (six-minute walk test) : baseline(Functional capacity is assessed at the beginning of the rehabilitation program : day 0)
- Relation between the cognitive function and the respiratory function (forced expiratory volume in 1 second)(The relation is assessed between baseline demographic data at day 0)
- Adherence(Adherence is assessed at the end of the rehabilitation program : day 60)