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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Pulmonary rehabilitation

• Registration Number: NCT03244137
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-31
• Study First Submitted QC: 2017-08-08
• Study First Posted: 2017-08-09
• Study Start: 2017-09-04
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pulmonary rehabilitation	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).

Primary Outcome Measures

Name	Time	Method
Baseline cognitive function	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 : follow up	Cognitive function is assessed 3 month after rehabilitation : day 150	Cognitive function is assessed with the Montreal Cognitive Assessement tool
Cognitive function after pulmonary rehabilitation	Cognitive function is assessed at the end of the rehabilitation program : day 60	Cognitive function is assessed with the Montreal Cognitive Assessement tool
Change in cognitive function from baseline to the end of pulmonary rehabilitation	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	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

Name	Time	Method
Functional capacity (six-minute stepper test) : baseline	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	Functional capacity is assessed at the end of the rehabilitation program : day 60	Functional capacity is assessed with the six-minute stepper test
Anxiety and depression : end of pulmonary rehabilitation	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).
Quality of life : end of pulmonary rehabilitation	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	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
Anxiety and depression : baseline	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 : follow up	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	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
Functional capacity (six-minute walk test) : baseline	Functional capacity is assessed at the beginning of the rehabilitation program : day 0	Functional capacity is assessed with the six-minute walk test
Relation between the cognitive function and the respiratory function (forced expiratory volume in 1 second)	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
Adherence	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

Trial Locations

Locations (2)

Bonnevie; 🇫🇷 Bois-Guillaume, France

Médrinal; 🇫🇷 Le Havre, France