- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00922857
Influence of Muscular Atrophy on Biological and Functional Benefit of Respiratory Rehabilitation in Patients With Chronic Respiratory Failure (INSPIRE)
The prevalence of chronic respiratory failure (CRF) is increasing worldwide and will become the 3rd cause of death by 2020. At the stage of the disease requiring ventilatory assistance, this relates to 50,000 patients in France, life expectancy is very limited, and quality of life is poor.
CRF led to a reduction in muscle mass, which is found in 35 and 55% of patients, in some to a profound cachexia. A reduced fat free mass (FFM) is a factor associated with a poor tolerance to exercise and an halved survival. The exact causes and mechanisms leading to cachexia are not yet established. Recently, a chronic inflammatory condition has been quoted as a putative cause. This chronic inflammation would involve the molecular mechanisms leading to poor regulation of the balance of synthesis / protein degradation in muscle. A decrease in plasma and muscle amino acids was found among patients with a low FFM.. In addition, a decrease of plasma levels of some anabolic hormones, GH and androgens or IGF-1 has been found that could explain a lack of protein synthesis.
It is now well established that respiratory rehabilitation, including a program of exercise reconditioning, increases tolerance to exercise and improve the quality of life. Besides the classical type of endurance exercises stimulating the cardio-respiratory system, it is suggested to add resistance exercises. Several studies have reported the benefit of this strategy but the link with intracellular molecular pathways has not been described; moreover, it is unknown whether the existence of an initial muscular atrophy influences the gain in muscle strength/mass.
연구 개요
상세 설명
We therefore propose to explore the effect of a rehabilitation program including endurance and resistance exercises on muscle biopsies.
The present study should help to know the molecular pathways implicated in muscle atrophy in CRF patients and to assess their evolution with rehabilitation. This could lead to individualized recommendation for exercise program according to the muscle mass of the patients.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Saint-etienne, 프랑스, 42055
- CHU de Saint-Etienne
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Prescription of an exercise training program as part of a respiratory rehabilitation
- Existence of an obstructive ventilatory deficit
- Signature of written consent
Exclusion Criteria:
- Exacerbation of COPD
- Patient with a long-term oxygen therapy
- Active smoker
- Lower limb locomotor limitation preventing to achieve the full respiratory rehabilitation program
- Lower limbs arteritis
- Myocardial infarction or pulmonary embolism of less than 3 months
- Long term anticoagulant
- Type 1 diabetes
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Respiratory rehabilitation
|
The training begins 5 days after the initial assessment.
It consists of 3 weekly sessions for 8 consecutive weeks, including the following activities interspersed with periods of rest, according to the needs of patients
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Gain in exercise tolerance (relative variation of the 6 min walking distance and maximal exercise capacity on bicycle (peak VO2) combined with activation of the pathway for muscle protein synthesis
기간: before and at the outcome of the reconditioning program in the effort
|
before and at the outcome of the reconditioning program in the effort
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
Quality of life assessed by questionnaire
기간: before and at the outcome of the reconditioning program in the effort
|
before and at the outcome of the reconditioning program in the effort
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Frédéric COSTES, MD PhD, CHU de Saint-Etienne
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .
호흡 부전에 대한 임상 시험
-
Umeå UniversityKarolinska University Hospital; Sahlgrenska University Hospital, Sweden; University Hospital... 그리고 다른 협력자들모병고립성 또는 복합성 구개열이 있는 소아의 Velopharyngeal Insufficiency스웨덴
Respiratory rehabilitation에 대한 임상 시험
-
Uskudar State Hospital아직 모집하지 않음폐 질환 | 폐 재활 | 원격 의료