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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03244137
• Other study ID #: PR-COPD
• Status: Completed
• Start date: September 4, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: January 2020
• Source: ADIR Association
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Pulmonary rehabilitation
See group description.

Locations

Country	Name	City	State
France	Bonnevie	Bois-Guillaume
France	Médrinal	Le Havre

Sponsors (3)

Lead Sponsor	Collaborator
ADIR Association	CHU de Rouen - Accueil, Groupe Hospitalier du Havre

Country where clinical trial is conducted

France, 

Outcome

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