Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
2020년 1월 6일 업데이트: 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.
연구 개요
연구 유형
관찰
등록 (실제)
56
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Bois-Guillaume, 프랑스, 76230
- Bonnevie
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Le Havre, 프랑스, 76600
- Médrinal
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
해당 없음
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
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.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Baseline cognitive function
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Anxiety and depression : baseline
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: 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.
- 연구 의자: 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.
- 연구 의자: Tardif Catherine, MD, CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France
- 연구 의자: Viacroze Catherine, MD, CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de pneumologie, Bois-Guillaume, France
- 연구 의자: Debeaumont David, MD, CHU-Hôpitaux de Rouen - Hôpital de Bois-Guillaume, Service de physiologie urinaire, digestive, respiratoire et sportive, Bois-Guillaume, France.
- 연구 의자: 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
- 연구 의자: 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.
- 연구 의자: Quieffin Jean, MD, Service de pneumologie, Hôpital Jacques Monod 76290 Montivilliers.
- 연구 의자: Prieur Guillaume, PT, MsC, Service de pneumologie, Groupe Hospitalier du Havre, Fr
- 연구 의자: 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
- 연구 의자: Gravier Francis-Edouard, PT, ADIR Association, Bois-Guillaume, France
- 연구 의자: 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2017년 9월 4일
기본 완료 (실제)
2019년 12월 1일
연구 완료 (실제)
2019년 12월 1일
연구 등록 날짜
최초 제출
2017년 7월 31일
QC 기준을 충족하는 최초 제출
2017년 8월 8일
처음 게시됨 (실제)
2017년 8월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 1월 7일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 1월 6일
마지막으로 확인됨
2020년 1월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- PR-COPD
약물 및 장치 정보, 연구 문서
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아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Pulmonary rehabilitation에 대한 임상 시험
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