- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Kontakty i lokalizacje
Lokalizacje studiów
-
-
-
Bois-Guillaume, Francja, 76230
- Bonnevie
-
Le Havre, Francja, 76600
- Médrinal
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
---|---|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Baseline cognitive function
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Anxiety and depression : baseline
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: 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.
- Krzesło do nauki: 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.
- Krzesło do nauki: Tardif Catherine, MD, CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
- Krzesło do nauki: Viacroze Catherine, MD, CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
- Krzesło do nauki: Debeaumont David, MD, CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France.
- Krzesło do nauki: 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
- Krzesło do nauki: 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.
- Krzesło do nauki: Quieffin Jean, MD, Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers.
- Krzesło do nauki: Prieur Guillaume, PT, MsC, Service de pneumologie, Groupe Hospitalier du Havre, Fr
- Krzesło do nauki: 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
- Krzesło do nauki: Gravier Francis-Edouard, PT, ADIR Association, Bois-Guillaume, France
- Krzesło do nauki: 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- PR-COPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Przewlekła obturacyjna choroba płuc
-
Spero TherapeuticsZakończonyKompleks Mycobacterium Avium | Niegruźlicze Mycobacterium Pulmonary DiseaseStany Zjednoczone
Badania kliniczne na Pulmonary rehabilitation
-
University Hospital, LinkoepingLinkoeping University; Ryhov County HospitalNieznany
-
University of KonstanzWorld BankNieznanyZespołu stresu pourazowego | Agresja apetycznaKongo