- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
-
Bois-Guillaume, Frankrijk, 76230
- Bonnevie
-
Le Havre, Frankrijk, 76600
- Médrinal
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
---|---|
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).
|
See group description.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Baseline cognitive function
Tijdsspanne: 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 is assessed at the beginning of the rehabilitation program : day 0
|
Cognitive function after pulmonary rehabilitation
Tijdsspanne: 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 is assessed at the end of the rehabilitation program : day 60
|
Cognitive function : follow up
Tijdsspanne: Cognitive function is assessed 3 month after rehabilitation : day 150
|
Cognitive function is assessed with the Montreal Cognitive Assessement tool
|
Cognitive function is assessed 3 month after rehabilitation : day 150
|
Change in cognitive function from baseline to the end of pulmonary rehabilitation
Tijdsspanne: 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 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
Tijdsspanne: 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
|
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)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Anxiety and depression : baseline
Tijdsspanne: 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 are assessed at the beginning of the rehabilitation program : day 0
|
Anxiety and depression : end of pulmonary rehabilitation
Tijdsspanne: 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).
|
Anxiety and depression are assessed at the end of the rehabilitation program : day 60
|
Anxiety and depression : follow up
Tijdsspanne: 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).
|
Anxiety and depression are assesses 3 month after the end of pulmonary rehabilitation program : day 150
|
Quality of life : baseline
Tijdsspanne: 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
|
Quality of life is assessed at the beginning of the rehabilitation program : day 0
|
Quality of life : end of pulmonary rehabilitation
Tijdsspanne: 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 is assessed at the end of the rehabilitation program : day 60
|
Quality of life : follow-up
Tijdsspanne: 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
|
Quality of life is assessed 3 month after the end of the rehabilitation program : day 150
|
Functional capacity (six-minute stepper test) : baseline
Tijdsspanne: 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 is assessed at the beginning of the rehabilitation program : day 0
|
Functional capacity (six-minute stepper test) : end of pulmonary rehabilitation
Tijdsspanne: Functional capacity is assessed at the end of the rehabilitation program : day 60
|
Functional capacity is assessed with the six-minute stepper test
|
Functional capacity is assessed at the end of the rehabilitation program : day 60
|
Functional capacity (six-minute walk test) : baseline
Tijdsspanne: Functional capacity is assessed at the beginning of the rehabilitation program : day 0
|
Functional capacity is assessed with the six-minute walk test
|
Functional capacity is assessed at the beginning of the rehabilitation program : day 0
|
Adherence
Tijdsspanne: 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
|
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)
Tijdsspanne: 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
|
The relation is assessed between baseline demographic data at day 0
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: 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.
- Studie stoel: 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.
- Studie stoel: Tardif Catherine, MD, CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
- Studie stoel: Viacroze Catherine, MD, CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
- Studie stoel: Debeaumont David, MD, CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France.
- Studie stoel: 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
- Studie stoel: 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.
- Studie stoel: Quieffin Jean, MD, Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers.
- Studie stoel: Prieur Guillaume, PT, MsC, Service de pneumologie, Groupe Hospitalier du Havre, Fr
- Studie stoel: 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
- Studie stoel: Gravier Francis-Edouard, PT, ADIR Association, Bois-Guillaume, France
- Studie stoel: 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PR-COPD
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Pulmonary rehabilitation
-
Spaulding Rehabilitation HospitalNortheastern UniversityBeëindigdLooptraining bij gezonde proefpersonen | Looptraining bij overlevenden van een beroerteVerenigde Staten
-
Universidad Pública de NavarraMutua NavarraOnbekendSchouder Impingement | Rotator cuff-ziekteSpanje
-
Donders Centre for NeuroscienceWervingHartinfarctFrankrijk, Roemenië, Spanje
-
Odense University HospitalUniversity of Southern Denmark; Odense Patient Data Explorative Network; REHPA... en andere medewerkersVoltooidHartstilstand Met Succesvolle ReanimatieDenemarken
-
IRCCS Eugenio MedeaWervingSpierdystrofieën | Becker spierdystrofie | Ledematen Gordel Spierdystrofie | Facio-Scapulo-Humerale DystrofieItalië
-
University of KonstanzWorld BankOnbekendPost-traumatische stress-stoornis | Agressie van de eetlustCongo
-
Washington University School of MedicineVoltooid
-
University of KonstanzVoltooidAgressie van de eetlustDuitsland
-
Psychiatric Research Unit, Region Zealand, DenmarkIngetrokkenPsychiatrische ziekenhuisopname
-
Yonsei UniversityNog niet aan het wervenBoezemfibrillerenKorea, republiek van