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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 1, 2019

Interventions

  • Other: Pulmonary rehabilitation
    • See group description.

Arms, Groups and Cohorts

  • 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).

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Anxiety and depression : baseline
    • Time Frame: Anxiety and depression are assessed at the beginning of the rehabilitation program : day 0
    • Anxiety and depression are assessed with the Hospital Anxiety and Depression scale (HAD).
  • Anxiety and depression : end of pulmonary rehabilitation
    • Time Frame: Anxiety and depression are assessed at the end of the rehabilitation program : day 60
    • Anxiety and depression are assessed with the Hospital Anxiety and Depression scale (HAD).
  • Anxiety and depression : follow up
    • Time Frame: Anxiety and depression are assesses 3 month after the end of pulmonary rehabilitation program : day 150
    • Anxiety and depression are assessed with the Hospital Anxiety and Depression scale (HAD).
  • Quality of life : baseline
    • Time Frame: Quality of life is assessed at the beginning of the rehabilitation program : day 0
    • Quality of life is assessed using the Saint Georges Respiratory Questionnaire
  • Quality of life : end of pulmonary rehabilitation
    • Time Frame: Quality of life is assessed at the end of the rehabilitation program : day 60
    • Quality of life is assessed using the Saint Georges Respiratory Questionnaire
  • Quality of life : follow-up
    • Time Frame: Quality of life is assessed 3 month after the end of the rehabilitation program : day 150
    • Quality of life is assessed using the Saint Georges Respiratory Questionnaire
  • Functional capacity (six-minute stepper test) : baseline
    • Time Frame: Functional capacity is assessed at the beginning of the rehabilitation program : day 0
    • Functional capacity is assessed with the six-minute stepper test
  • Functional capacity (six-minute stepper test) : end of pulmonary rehabilitation
    • Time Frame: Functional capacity is assessed at the end of the rehabilitation program : day 60
    • Functional capacity is assessed with the six-minute stepper test
  • Functional capacity (six-minute walk test) : baseline
    • Time Frame: Functional capacity is assessed at the beginning of the rehabilitation program : day 0
    • Functional capacity is assessed with the six-minute walk test
  • Adherence
    • Time Frame: Adherence is assessed at the end of the rehabilitation program : day 60
    • Adherence to the pulmonary rehabilitation program is assessed by the following equation : number of session performed divided by the number of scheduled sessions
  • Relation between the cognitive function and the respiratory function (forced expiratory volume in 1 second)
    • Time Frame: The relation is assessed between baseline demographic data at day 0
    • Cognitive function is assessed with the Montreal Cognitive Assessement tool and respiratory function is assessed with spirometric evaluation

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • ADIR Association
  • Collaborator
    • CHU de Rouen – Accueil
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Cuvelier Antoine, Prof, PhD, 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, 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, Study Chair, CHU-Hôpitaux de Rouen – Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
    • Viacroze Catherine, MD, Study Chair, CHU-Hôpitaux de Rouen – Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
    • Debeaumont David, MD, Study Chair, CHU-Hôpitaux de Rouen – Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France.
    • Patout Maxime, MD, 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, 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, Study Chair, Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers.
    • Prieur Guillaume, PT, MsC, Study Chair, Service de pneumologie, Groupe Hospitalier du Havre, Fr
    • Médrinal Clément, PT, MsC, 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, Study Chair, ADIR Association, Bois-Guillaume, France
    • Bonnevie Tristan, PT, MsC, 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.
  • Overall Contact(s)
    • Bonnevie Tristan, PT, MsC, 06 50 49 97 69, rehabilitation@adir-hautenormandie.com

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