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

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ClinicalTrials.gov Identifier: NCT03244137
Recruitment Status : Recruiting
First Posted : August 9, 2017
Last Update Posted : January 9, 2019
Sponsor:
Collaborators:
CHU de Rouen - Accueil
Groupe Hospitalier du Havre
Information provided by (Responsible Party):
ADIR Association

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.


Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Other: Pulmonary rehabilitation

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
Actual Study Start Date : September 4, 2017
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
See group description.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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 Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03244137


Contacts
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Contact: Bonnevie Tristan, PT, MsC 06 50 49 97 69 ext +33 rehabilitation@adir-hautenormandie.com

Locations
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France
Bonnevie Recruiting
Bois-Guillaume, France, 76230
Contact: Bonnevie Tristan, PT, MsC    0235592970 ext +33    rehabilitation@adir-hautenormandie.com   
Principal Investigator: Bonnevie Tristan, PT, MsC         
Médrinal Recruiting
Le Havre, France, 76600
Contact: Clément Médrinal, PT, MsC    02 32 73 32 32 ext +33      
Contact       medrinal.clement.mk@gmail.com   
Principal Investigator: Clément Médrinal, PT, MsC         
Sponsors and Collaborators
ADIR Association
CHU de Rouen - Accueil
Groupe Hospitalier du Havre
Investigators
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Principal Investigator: 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.
Study Chair: 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.

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Responsible Party: ADIR Association
ClinicalTrials.gov Identifier: NCT03244137     History of Changes
Other Study ID Numbers: PR-COPD
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases