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OpenTrials
Completed

NCT Number: NCT03244137

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bonnevie, Bois-Guillaume, France

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Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulmonary Rehabilitation

Other

See group description.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

ADIR Association

Other

Collaborators

  • CHU de Rouen - Accueil
  • Groupe Hospitalier du Havre

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 9, 2017
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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