Chronic Obstructive Pulmonary DiseaseNCT03244137

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

An observational study of Chronic Obstructive Pulmonary Disease, run by ADIR Association at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: Pulmonary rehabilitation
How many people: 56 participants
Where: 2 sitesFrance
Study dates: 4 Sep 2017to 1 Dec 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Adult, Older adult

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.

Who may be able to join

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;

Show all 9Show fewer

Active alcoholism;
Guardianship;
Hospitalisation for acute exacerbation of chronic obstructive pulmonary disease in the previous 4 weeks;

Who cannot join

Interruption of the pulmonary rehabilitation program > 15 days;
Disruption of the training before the 18th session;
Less than 18 sessions in four month.

Trial locations and contacts

2 sites in 1 country.

France2 sites

Bonnevie
Bois-Guillaume, 76230
Médrinal
Le Havre, 76600

Other trials in France

About this study

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.

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: Pulmonary rehabilitation
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pulmonary rehabilitationOther
See group description.

Study groups in NCT03244137
Study group	Role	What they receive
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). Receives: Other: Pulmonary rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

Baseline cognitive function
Cognitive function is assessed with the Montreal Cognitive Assessement tool
Measured: Cognitive function is assessed at the beginning of the rehabilitation program : day 0
Cognitive function after pulmonary rehabilitation
Cognitive function is assessed with the Montreal Cognitive Assessement tool
Measured: Cognitive function is assessed at the end of the rehabilitation program : day 60
Cognitive function : follow up
Cognitive function is assessed with the Montreal Cognitive Assessement tool
Measured: Cognitive function is assessed 3 month after rehabilitation : day 150
Change in cognitive function from baseline to the end of pulmonary rehabilitation
Cognitive function is assessed with the Montreal Cognitive Assessement tool
Measured: 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)
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
Measured: 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 outcomes (11)

Anxiety and depression : baseline
Anxiety and depression are assessed with the Hospital Anxiety and Depression scale (HAD).
Measured: Anxiety and depression are assessed at the beginning of the rehabilitation program : day 0
Anxiety and depression : end of pulmonary rehabilitation
Anxiety and depression are assessed with the Hospital Anxiety and Depression scale (HAD).
Measured: Anxiety and depression are assessed at the end of the rehabilitation program : day 60
Anxiety and depression : follow up
Anxiety and depression are assessed with the Hospital Anxiety and Depression scale (HAD).
Measured: Anxiety and depression are assesses 3 month after the end of pulmonary rehabilitation program : day 150
Quality of life : baseline
Quality of life is assessed using the Saint Georges Respiratory Questionnaire
Measured: Quality of life is assessed at the beginning of the rehabilitation program : day 0
Quality of life : end of pulmonary rehabilitation
Quality of life is assessed using the Saint Georges Respiratory Questionnaire
Measured: Quality of life is assessed at the end of the rehabilitation program : day 60
Quality of life : follow-up
Quality of life is assessed using the Saint Georges Respiratory Questionnaire
Measured: Quality of life is assessed 3 month after the end of the rehabilitation program : day 150
Functional capacity (six-minute stepper test) : baseline
Functional capacity is assessed with the six-minute stepper test
Measured: Functional capacity is assessed at the beginning of the rehabilitation program : day 0
Functional capacity (six-minute stepper test) : end of pulmonary rehabilitation
Functional capacity is assessed with the six-minute stepper test
Measured: Functional capacity is assessed at the end of the rehabilitation program : day 60
Functional capacity (six-minute walk test) : baseline
Functional capacity is assessed with the six-minute walk test
Measured: Functional capacity is assessed at the beginning of the rehabilitation program : day 0
Adherence
Adherence to the pulmonary rehabilitation program is assessed by the following equation : number of session performed divided by the number of scheduled sessions
Measured: Adherence is assessed at the end of the rehabilitation program : day 60
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
Measured: The relation is assessed between baseline demographic data at day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Sep 20171 Dec 2019

First posted9 Aug 2017
Study start4 Sep 2017
Primary completion1 Dec 2019
Study completion1 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03244137
Sponsor's protocol ID: PR-COPD
Status last verified: Jan 2020
First submitted: 31 Jul 2017
Last updated: 7 Jan 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
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Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT03244137
Acronym / sponsor ID: PR-COPD
Conditions: Chronic Obstructive Pulmonary Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: ADIR AssociationUniversity, hospital or other
Collaborators: CHU de Rouen - Accueil, Groupe Hospitalier du Havre
Study start: 4 Sep 2017 (actual)
Primary completion: 1 Dec 2019 (actual)
Study completion: 1 Dec 2019 (actual)
First posted: 9 Aug 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Pulmonary rehabilitation	–	Other: Pulmonary rehabilitationThe 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).

Who may qualify

Ages: 18 years and older
Sex: All
Age groups: Adult, Older adult
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.

Key inclusion criteria (9 listed)

Age > 18years;
Chronic obstructive pulmonary disease stade III to IV;
Referred for pulmonary rehabilitation.
Pregnancy or likely to be;
History of psychiatric, neuro-vascular, cognitive disease or cranial trauma;

Key exclusion criteria (3 listed)

Interruption of the pulmonary rehabilitation program > 15 days;
Disruption of the training before the 18th session;
Less than 18 sessions in four month.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pulmonary rehabilitationSee group description.	Other	Pulmonary rehabilitation

Primary outcome

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

11 secondary outcomes

Anxiety and depression : baseline
Time frame: Anxiety and depression are assessed at the beginning of the rehabilitation program : day 0
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 : follow up
Time frame: Anxiety and depression are assesses 3 month after the end of pulmonary rehabilitation program : day 150
Quality of life : baseline
Time frame: Quality of life is assessed at the beginning of the rehabilitation program : day 0
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 : follow-up
Time frame: Quality of life is assessed 3 month after the end of the rehabilitation program : day 150
Functional capacity (six-minute stepper test) : baseline
Time frame: Functional capacity is assessed at the beginning of the rehabilitation program : day 0
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 (six-minute walk test) : baseline
Time frame: Functional capacity is assessed at the beginning of the rehabilitation program : day 0
Adherence
Time frame: Adherence is assessed at the end of the rehabilitation program : day 60
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.

Related trials for Chronic Obstructive Pulmonary Disease

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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

Tardif Catherine, MD study chair

CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Obstructive Pulmonary Disease, run by ADIR Association at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Baseline cognitive function (time frame: Cognitive function is assessed at the beginning of the rehabilitation program : day 0). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03244137.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2020.