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

NCT03244137 | Completed

• 1 other identifier: PR-COPD
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (11)

• Anxiety and depression : baseline

  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 at the end of the rehabilitation program : day 60

• 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

• Quality of life : end of pulmonary rehabilitation

  Quality of life is assessed at the end of the rehabilitation program : day 60

Study Arms (1)

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).

Other: Pulmonary rehabilitation

Interventions

Pulmonary rehabilitation OTHER

See group description.

Pulmonary rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• Interruption of the pulmonary rehabilitation program \> 15 days;
• Disruption of the training before the 18th session;
• Less than 18 sessions in four month.

Sponsors & Collaborators

• ADIR Association: lead
• CHU de Rouen - Accueil: collaborator
• Groupe Hospitalier du Havre: collaborator

Study Sites (2)

Bonnevie

Bois-Guillaume, 76230, France

Location

Médrinal

Le Havre, 76600, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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

  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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 9, 2017
• Study Start: September 4, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: January 7, 2020

Record last verified: 2020-01

Locations

FR (2)