- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Bois-Guillaume, Frankrig, 76230
- Bonnevie
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Le Havre, Frankrig, 76600
- Médrinal
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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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).
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See group description.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Baseline cognitive function
Tidsramme: Cognitive function is assessed at the beginning of the rehabilitation program : day 0
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Cognitive function is assessed with the Montreal Cognitive Assessement tool
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Cognitive function is assessed at the beginning of the rehabilitation program : day 0
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Cognitive function after pulmonary rehabilitation
Tidsramme: Cognitive function is assessed at the end of the rehabilitation program : day 60
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Cognitive function is assessed with the Montreal Cognitive Assessement tool
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Cognitive function is assessed at the end of the rehabilitation program : day 60
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Cognitive function : follow up
Tidsramme: Cognitive function is assessed 3 month after rehabilitation : day 150
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Cognitive function is assessed with the Montreal Cognitive Assessement tool
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Cognitive function is assessed 3 month after rehabilitation : day 150
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Change in cognitive function from baseline to the end of pulmonary rehabilitation
Tidsramme: 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)
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Cognitive function is assessed with the Montreal Cognitive Assessement tool
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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)
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Change in cognitive function from the end of pulmonary rehabilitation to 3 month of follow up
Tidsramme: 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)
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Cognitive function is assessed with the Montreal Cognitive Assessement tool
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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)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Anxiety and depression : baseline
Tidsramme: Anxiety and depression are assessed at the beginning of the rehabilitation program : day 0
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Anxiety and depression are assessed with the Hospital Anxiety and Depression scale (HAD).
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Anxiety and depression are assessed at the beginning of the rehabilitation program : day 0
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Anxiety and depression : end of pulmonary rehabilitation
Tidsramme: Anxiety and depression are assessed at the end of the rehabilitation program : day 60
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Anxiety and depression are assessed with the Hospital Anxiety and Depression scale (HAD).
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Anxiety and depression are assessed at the end of the rehabilitation program : day 60
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Anxiety and depression : follow up
Tidsramme: Anxiety and depression are assesses 3 month after the end of pulmonary rehabilitation program : day 150
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Anxiety and depression are assessed with the Hospital Anxiety and Depression scale (HAD).
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Anxiety and depression are assesses 3 month after the end of pulmonary rehabilitation program : day 150
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Quality of life : baseline
Tidsramme: Quality of life is assessed at the beginning of the rehabilitation program : day 0
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Quality of life is assessed using the Saint Georges Respiratory Questionnaire
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Quality of life is assessed at the beginning of the rehabilitation program : day 0
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Quality of life : end of pulmonary rehabilitation
Tidsramme: Quality of life is assessed at the end of the rehabilitation program : day 60
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Quality of life is assessed using the Saint Georges Respiratory Questionnaire
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Quality of life is assessed at the end of the rehabilitation program : day 60
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Quality of life : follow-up
Tidsramme: Quality of life is assessed 3 month after the end of the rehabilitation program : day 150
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Quality of life is assessed using the Saint Georges Respiratory Questionnaire
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Quality of life is assessed 3 month after the end of the rehabilitation program : day 150
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Functional capacity (six-minute stepper test) : baseline
Tidsramme: Functional capacity is assessed at the beginning of the rehabilitation program : day 0
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Functional capacity is assessed with the six-minute stepper test
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Functional capacity is assessed at the beginning of the rehabilitation program : day 0
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Functional capacity (six-minute stepper test) : end of pulmonary rehabilitation
Tidsramme: Functional capacity is assessed at the end of the rehabilitation program : day 60
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Functional capacity is assessed with the six-minute stepper test
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Functional capacity is assessed at the end of the rehabilitation program : day 60
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Functional capacity (six-minute walk test) : baseline
Tidsramme: Functional capacity is assessed at the beginning of the rehabilitation program : day 0
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Functional capacity is assessed with the six-minute walk test
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Functional capacity is assessed at the beginning of the rehabilitation program : day 0
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Adherence
Tidsramme: Adherence is assessed at the end of the rehabilitation program : day 60
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Adherence to the pulmonary rehabilitation program is assessed by the following equation : number of session performed divided by the number of scheduled sessions
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Adherence is assessed at the end of the rehabilitation program : day 60
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Relation between the cognitive function and the respiratory function (forced expiratory volume in 1 second)
Tidsramme: The relation is assessed between baseline demographic data at day 0
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Cognitive function is assessed with the Montreal Cognitive Assessement tool and respiratory function is assessed with spirometric evaluation
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The relation is assessed between baseline demographic data at day 0
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
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