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

6. januar 2020 oppdatert av: ADIR Association

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Faktiske)

56

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Frankrike
      • Bois-Guillaume, Frankrike, 76230
        • Bonnevie
      • Le Havre, Frankrike, 76600
        • Médrinal

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

N/A

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / 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).
Annen: Pulmonary rehabilitation
See group description.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Baseline cognitive function
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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)
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
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)
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)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Anxiety and depression : baseline
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

ADIR Association

Samarbeidspartnere

Groupe Hospitalier du Havre
CHU de Rouen - Accueil

Etterforskere

  • Hovedetterforsker: 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.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

4. september 2017

Primær fullføring (Faktiske)

1. desember 2019

Studiet fullført (Faktiske)

1. desember 2019

Datoer for studieregistrering

Først innsendt

31. juli 2017

Først innsendt som oppfylte QC-kriteriene

8. august 2017

Først lagt ut (Faktiske)

9. august 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. januar 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. januar 2020

Sist bekreftet

1. januar 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PR-COPD

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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