- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03152344
Evaluation of a Simple Clinical Test to Detect the Risk of Falling in Patients With BPCO and Research for Predictive Factors of Fall Risk. (Equil-BPCO)
Evaluation of a Simple Clinical Test to Detect the Risk of Falling in Patients With Chronic Obstructive Pulmonary Disease and Research for Predictive Factors of Fall Risk.
The risk of falling in increased in patients with Chronic Obstructive Pulmonary Disease. To date, a screening test (the Berg Balance scale, BBS) is used to evaluate this risk but it spends 20 to 30 minutes to complete.
The aim of our study is to evaluate the sensitivity of a more straightforward test (Timed Up and Go, TUG)) to assess the fall risk. The TUG is routinely used in elderly to screen for frailty.
연구 개요
상세 설명
We will recruit COPD patients in stable condition (free of exacerbation of the disease for a month), 40 without chronic respiratory failure and 40 with home oxygen therapy.
The patients will be proposed to perform the following tests and to fill in questionnaires:
- Questionnaires: Elderly Falls Screening Test to quantify the falls in the last year, Hospital Anxiety and Depression Scale, Activities-specific Balance Confidence scale.
Tests:
- Berg Balance Scale measuring balance in 14 different functional tasks (abnormal cut-off value <56)
- Timed Up and Go evaluating the time to rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down (abnormal cut-off value >12 seconds).
- 6 minute walk test evaluating endurance to submaximal exercise.
- Isokinetic maximal force of the quadriceps at 60°/s
- Balance control: posturography consisting in measuring variations when standing on a force platform.
- Body composition assessment through Dual Xray Absorptiometry (DXA), to measure body muscle mass and more specifically appendicular muscle mass index as a criteria of sarcopenia, and bone mineral density.
- Blood analysis: a blood sample will be withdrawn to measure calcium, phosphorus, vitamin D, albumin transthyretin, cell count, C reactive protein.
Analysis of the results:
We will calculate the sensitivity of the TUG test (abnormal test) to detect fall risk as assessed by an abnormal BBS score.
Moreover, in fallers, we will search for predictive factors. More specifically, we will look for the role of a decreased quadriceps force, a reduced muscle mass, a poor tolerance of exercise, the presence of hypoxia (severity of the disease).
Perspectives:
When validated as a screening test for the risk of falling in COPD patients, the TUG test could be used routinely by physiotherapists as a more simple and faster test and will enable to prevent falls through initiation of a balance control training program.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Auvergne
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Clermont-Ferrand, Auvergne, 프랑스, 63003
- CHU de Clermont-Ferrand
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- COPD confirmed by pulmonary function tests
- Long term oxygen therapy since at least 3 months in the LOT+ subgroup
Exclusion Criteria:
- Exacerbation of COPD necessitating an hospitalization or an oral corticosteroid treatment, in the last 4 weeks
- Pulmonary rehabilitation in the last 3 months
- Any neurological disease affecting balance control.
- Inability to perform a walk test
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
COPD patients without chronic respiratory failure
We will recruit COPD patients in stable condition (free of exacerbation of the disease for a month), 40 without chronic respiratory failure and 40 with home oxygen therapy. The patients will be proposed to perform the following tests and to fill in questionnaires |
It's a functional test evaluating the time to rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down (abnormal cut-off value >12 seconds).
|
COPD patients with home oxygen therapy
We will recruit COPD patients in stable condition (free of exacerbation of the disease for a month), 40 without chronic respiratory failure and 40 with home oxygen therapy. The patients will be proposed to perform the following tests and to fill in questionnaires |
It's a functional test evaluating the time to rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down (abnormal cut-off value >12 seconds).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Comparison of the Timed Up and Go test and the Berg Balance scale
기간: at day 1
|
Comparison of the consistency of abnormal value of the Timed Up and Go test and the Berg Balance scale
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at day 1
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Sensitivity of the TUG test and the BBS
기간: at day 1
|
to detect fall as assessed by the Elderly Falls Screening Test.
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at day 1
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Difference in BBS score
기간: at day 1
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between COPD patients without and with chronic respiratory failure (LOT+/- subgroups).
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at day 1
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Identify predictive factors of fall risk
기간: at day 1
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walk distance, quadriceps force, muscle mass, balance control.
|
at day 1
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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. .
COPD Diagnosed에 대한 임상 시험
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Istituto Nazionale di Ricovero e Cura per Anziani모병
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Bio-Sensing Solutions S.L. (DyCare)Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; Centre de Validació...아직 모집하지 않음
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The First Affiliated Hospital of Guangzhou Medical...모병
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Association des Réseaux BronchioliteLaboratoire Système et Matériaux pour la Mécatronique (SYMME)모병
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Polytechnic Institute of PortoNippon Gases Portugal모병
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Icahn School of Medicine at Mount SinaiNational Heart, Lung, and Blood Institute (NHLBI)모병
Timed Up and Go에 대한 임상 시험
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Dalarna UniversityUppsala University; The Swedish Research Council모병백치 | 가벼운 인지 장애 | 치매, 혼합 | 알츠하이머형 치매 | 주관적 인지 장애 | 치매 노인성스웨덴
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University of Rhode IslandStuart Sinoff, MD; Peter J Snyder, MD; BayCare Health System모병
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University of Florida모병
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Istanbul University - Cerrahpasa (IUC)완전한
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Istinye University초대로 등록
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UNC Lineberger Comprehensive Cancer CenterNational Cancer Institute (NCI)완전한우울증 | 백혈병 | 피로 | 암과 치료의 심리사회적 영향 | 근골격계 합병증미국