- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
-
Bois-Guillaume, Frankrike, 76230
- Bonnevie
-
Le Havre, Frankrike, 76600
- Médrinal
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Baseline cognitive function
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Anxiety and depression : baseline
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: 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.
- Studiestol: 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.
- Studiestol: Tardif Catherine, MD, CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
- Studiestol: Viacroze Catherine, MD, CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
- Studiestol: Debeaumont David, MD, CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France.
- Studiestol: 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
- Studiestol: 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.
- Studiestol: Quieffin Jean, MD, Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers.
- Studiestol: Prieur Guillaume, PT, MsC, Service de pneumologie, Groupe Hospitalier du Havre, Fr
- Studiestol: 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
- Studiestol: Gravier Francis-Edouard, PT, ADIR Association, Bois-Guillaume, France
- Studiestol: 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PR-COPD
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Pulmonary rehabilitation
-
Uskudar State HospitalHar inte rekryterat ännuLungsjukdom | Lungrehabilitering | Telehälsa
-
Rostrum Medical Innovations Inc.Medical InitiativesHar inte rekryterat ännuStroke | Lunginflammation | KOL | Akut lungskada/akut andnödssyndrom (ARDS) | Ventilatorer, mekaniskaFrankrike, Förenta staterna, Österrike, Tjeckien
-
Shirley Ryan AbilityLabU.S. Department of EducationAvslutadRyggmärgsskadaFörenta staterna
-
Linkoeping UniversityOstergotland County Council, Sweden; Fibromyalgia foundationHar inte rekryterat ännuÖvervikt och fetma | Smärta, kronisk | Användning av mobiltelefon | Dålig näring
-
Medtronic - MITGAvslutadAndningsinsufficiens | AndningsdepressionFörenta staterna
-
Spaulding Rehabilitation HospitalNortheastern UniversityAvslutadRehabilitering av bäckensnedvridning hos strokepatienter som använder robotiskt genererade kraftfältOmträning av gång i friska ämnen | Omträning av gång i Stroke SurvivorsFörenta staterna
-
Dartmouth-Hitchcock Medical CenterNational Institute of Mental Health (NIMH)AvslutadSchizofreni | Schizoaffektiv sjukdom | Bipolär sjukdom | Djup depressionFörenta staterna
-
Arizona State UniversityRekryteringStroke | Afasi | Talets apraxiFörenta staterna
-
Ospedale Generale Di Zona Moriggia-PelasciniAvslutadParkinsons sjukdom och Pisa syndromItalien
-
Donders Centre for NeuroscienceRekryteringStrokeFrankrike, Rumänien, Spanien