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

NCT ID: NCT03244137

Last Updated: 2020-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-04

Study Completion Date

2019-12-01

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.

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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).

Pulmonary rehabilitation

Intervention Type OTHER

See group description.

Interventions

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Pulmonary rehabilitation

See group description.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age \> 18years;
* Chronic obstructive pulmonary disease stade III to IV;
* Referred for pulmonary rehabilitation.


* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CHU de Rouen - Accueil

OTHER

Sponsor Role collaborator

Groupe Hospitalier du Havre

OTHER

Sponsor Role collaborator

ADIR Association

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cuvelier Antoine, Prof, PhD

Role: PRINCIPAL_INVESTIGATOR

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.

Muir Jean-François, Prof, PhD

Role: STUDY_CHAIR

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.

Tardif Catherine, MD

Role: STUDY_CHAIR

CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France

Viacroze Catherine, MD

Role: STUDY_CHAIR

CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France

Debeaumont David, MD

Role: STUDY_CHAIR

CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France.

Patout Maxime, MD

Role: STUDY_CHAIR

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

Lamia Bouchra, Prof, PhD

Role: STUDY_CHAIR

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.

Quieffin Jean, MD

Role: STUDY_CHAIR

Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers.

Prieur Guillaume, PT, MsC

Role: STUDY_CHAIR

Service de pneumologie, Groupe Hospitalier du Havre, Fr

Médrinal Clément, PT, MsC

Role: STUDY_CHAIR

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

Gravier Francis-Edouard, PT

Role: STUDY_CHAIR

ADIR Association, Bois-Guillaume, France

Bonnevie Tristan, PT, MsC

Role: STUDY_CHAIR

ADIR Association, Bois-Guillaume, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France.

Locations

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Bonnevie

Bois-Guillaume, , France

Site Status

Médrinal

Le Havre, , France

Site Status

Countries

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France

Other Identifiers

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PR-COPD

Identifier Type: -

Identifier Source: org_study_id

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