Clinical trial NCT03244137: Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
Official title: Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: ADIR Association
Sponsor class: OTHER
Collaborators: name: CHU de Rouen - Accueil
name: Groupe Hospitalier du Havre
First posted: 2017-08-09
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.


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.

Primary outcomes:
measure: Baseline cognitive function
timeFrame: Cognitive function is assessed at the beginning of the rehabilitation program : day 0
measure: Cognitive function after pulmonary rehabilitation
timeFrame: Cognitive function is assessed at the end of the rehabilitation program : day 60
measure: Cognitive function : follow up
timeFrame: Cognitive function is assessed 3 month after rehabilitation : day 150
measure: Change in cognitive function from baseline to the end of pulmonary rehabilitation
timeFrame: 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)
measure: Change in cognitive function from the end of pulmonary rehabilitation to 3 month of follow up
timeFrame: 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 outcomes:
measure: Anxiety and depression : baseline
timeFrame: Anxiety and depression are assessed at the beginning of the rehabilitation program : day 0
measure: Anxiety and depression : end of pulmonary rehabilitation
timeFrame: Anxiety and depression are assessed at the end of the rehabilitation program : day 60
measure: Anxiety and depression : follow up
timeFrame: Anxiety and depression are assesses 3 month after the end of pulmonary rehabilitation program : day 150
measure: Quality of life : baseline
timeFrame: Quality of life is assessed at the beginning of the rehabilitation program : day 0
measure: Quality of life : end of pulmonary rehabilitation
timeFrame: Quality of life is assessed at the end of the rehabilitation program : day 60
measure: Quality of life : follow-up
timeFrame: Quality of life is assessed 3 month after the end of the rehabilitation program : day 150
measure: Functional capacity (six-minute stepper test) : baseline
timeFrame: Functional capacity is assessed at the beginning of the rehabilitation program : day 0
measure: Functional capacity (six-minute stepper test) : end of pulmonary rehabilitation
timeFrame: Functional capacity is assessed at the end of the rehabilitation program : day 60
measure: Functional capacity (six-minute walk test) : baseline
timeFrame: Functional capacity is assessed at the beginning of the rehabilitation program : day 0
measure: Adherence
timeFrame: Adherence is assessed at the end of the rehabilitation program : day 60
measure: Relation between the cognitive function and the respiratory function (forced expiratory volume in 1 second)
timeFrame: The relation is assessed between baseline demographic data at day 0
Other outcomes:
Locations:
city: Bois-Guillaume
country: France
facility: Bonnevie
city: Le Havre
country: France
facility: Médrinal
Study officials:
affiliation: 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.
name: Cuvelier Antoine, Prof, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: 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.
name: Muir Jean-François, Prof, PhD
role: STUDY_CHAIR
affiliation: CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
name: Tardif Catherine, MD
role: STUDY_CHAIR
affiliation: CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
name: Viacroze Catherine, MD
role: STUDY_CHAIR
affiliation: CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France.
name: Debeaumont David, MD
role: STUDY_CHAIR
affiliation: 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
name: Patout Maxime, MD
role: STUDY_CHAIR
affiliation: 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.
name: Lamia Bouchra, Prof, PhD
role: STUDY_CHAIR
affiliation: Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers.
name: Quieffin Jean, MD
role: STUDY_CHAIR
affiliation: Service de pneumologie, Groupe Hospitalier du Havre, Fr
name: Prieur Guillaume, PT, MsC
role: STUDY_CHAIR
affiliation: 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
name: Médrinal Clément, PT, MsC
role: STUDY_CHAIR
affiliation: ADIR Association, Bois-Guillaume, France
name: Gravier Francis-Edouard, PT
role: STUDY_CHAIR
affiliation: ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France.
name: Bonnevie Tristan, PT, MsC
role: STUDY_CHAIR
References: