- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02223962
Effects of Physical Activity Counseling After an Exacerbation in COPD
The Effects of a Physical Activity Counseling Program Immediately After an Exacerbation in Patients With COPD.
연구 개요
상세 설명
After signing the informed consent, the patients will be randomized into a control group, receiving usual care, or the intervention group receiving real-time feedback and physical activity counseling.
Intervention: Physical activity counseling will be provided by 3 weekly telephone contacts based on the step count from the Fitbit Ultra. In agreement with the patient and based on the step counts a patients provided, a new goal for the next week was set. The goal was to strive for the highest possible level of physical activity during one month.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Leuven, 벨기에, 3000
- University Hospital Leuven
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Signed Informed Consent
- Chronic Obstructive Lung Disease (Tiff<70%)
- Hospitalized because of exacerbation
- Capable of working with electronic devices
Exclusion Criteria:
- Orthopedic/Neurologic problems making it difficult to be active
- Participation in a rehabilitation program
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Physical activity
The fitbit Ultra was used to provide real-time feedback on physical activity.
An experienced physiotherapist contacted the subjects 3 times a week to receive information about the amount of steps from the previous days.
In agreement with the patient, a new goal for the coming weeks was set and patients were motivated to achieve their individual goal.
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Counseling about physical activity will only be provided in the intervention group by 3 weekly telephone contacts.
Based on the information the physiotherapist receives, he or she will adapt the goal (in agreement with the patient) and motivate the patient to reach the individual goal.
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위약 비교기: Usual Care
During the hospital stay, the patients in the control group will be informed about the beneficial effects of being physically inactive.They will not receive feedback about their activities performed and will not be stimulated to become more active.
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Counseling about physical activity will only be provided in the intervention group by 3 weekly telephone contacts.
Based on the information the physiotherapist receives, he or she will adapt the goal (in agreement with the patient) and motivate the patient to reach the individual goal.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Improvement in physical activity
기간: 1 month
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The Dynaport MoveMonitor, a valid device in patients with COPD, was used to accurately measure the level of physical activity.
The device was provided 3 times to the patients (baseline, after 2 weeks, after 1 month).
The amount of steps, measured by this device, was used as the outcome measure.
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1 month
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Improvement in functional exercise capacity
기간: 1 month
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Functional exercise capacity was measured by the six minutes walking distance test (6MWD; meter).
This measurement was performed at baseline and after 1 month.
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1 month
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공동 작업자 및 조사자
스폰서
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. .
COPD 악화에 대한 임상 시험
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Ryme Medical, Inc.아직 모집하지 않음COPD | 폐질환, 만성 폐쇄성 | COPD 환자 | COPD 급성 악화 | COPD(만성폐쇄성폐질환) | 폐 질환 항공 | COPD 악화
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Insel Gruppe AG, University Hospital BernUniversity Hospital, Geneva; Cantonal Hospital St. Gallen, Switzerland아직 모집하지 않음
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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...모병
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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
Physical activity에 대한 임상 시험
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The University of Hong Kong모병
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Istanbul Kültür UniversityMarmara University; Istanbul University - Cerrahpasa (IUC)완전한
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Foundation University Islamabad모병
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Karolinska InstitutetEvira AB완전한