Promotion of Ambulation Before Non-cardiac Surgery (PAMP-Phase2)
Impact of a Routine of Pre-surgical Walk for Non Cardiac Adult Patients Compared to Conventional Intervention (Not Recommended Exercise) in Reducing the Length of Hospital Stay and the Time of Onset of Ambulation.
Primary Determine the impact of prescribing a routine pre-surgical walk scheduled compared to conventional intervention (not recommended exercise) in reducing the length of hospital stay and the time of onset of ambulation during postoperative hospitalization, in patients with ability to move, ≥30 years who will undergo non-cardiac surgery.
Secondary
- Evaluate ischemic cardiovascular events (AMI), stroke (CVA) and cardiac mortality during hospitalization.
- Evaluate the incidence of falls during hospitalization.
Methodology The PAMP project phase II, as a component of CARDIECOL program will be implemented by designing a pilot study, a randomized controlled trial. Adult-patients with greater than or equal to 30 years old entering elective non-cardiac surgery, prior informed consent will be randomized to an intervention prescribed of walking in the period of 2-3 weeks before surgery or will be assigned to a Control group/conventional care. The study was not blinded to patients, but evaluation and analysis of the data will be blinded for researchers and statisticians. Patients will be evaluated on their previous level of physical activity and will be evaluated by a physiatrist doctor for prescribing the walk (exercise). This study will include a sample of 500 patients, with capacity to mobilize, ability to walk at least 30 min/by day (150 min by week) for at least 1 week before surgery. Patients have to be hospitalized for at least 24 hours after the surgical procedure. Outcomes are length of stay, and time to first walk. Other results are evaluation falls during hospitalization and the presence of falls, report of cardiovascular events, and death by group.
Expected results
연구 개요
상세 설명
Randomization was planned to be performed one to five weeks before non-cardiac surgery for all eligible patients, once they have decided to participate in the study. It was performed on a random computed to an intervention group (Walk prescription); or conventional care group (no exercise) in a 2:1 relation respectively. Intervention and Management Processes The pre surgical intervention walk routine is defined of at least 150-300 minutes of walk before going into surgery.
Analysis will be following the principle of intention to treat. A description of categorical and quantitative demographic data will be performed. Evaluation will also include the mean difference in the length of hospital stay for each of the groups and standard deviation, given a confidence interval of 95%. An analysis of the time of occurrence of the first walk using the Kaplan-Meier estimator will be performed.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Cundinamarca
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Bogotá, Cundinamarca, 콜롬비아
- Fundación Cardioinfantil Instituto de Cardiología
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Santander
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Bucaramanga, Santander, 콜롬비아
- Clinica Carlos Ardila Lulle-FOSCAL
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- undergoing non-cardiac surgery
- general anesthesia or epidural or spinal anesthesia
- age ≥ 30 years
- able to walk and communicate
Exclusion Criteria:
- having any alteration of their state of consciousness
- altered mental status and communication
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Walk prescription
Walk prescription for all weeks before non-cardiac surgery.
Duration of walk must be of 30-40 minutes every day for five days at the week or until complete 150 minutes at the week, for all weeks up to the surgery.
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30-40 minutes daily, for five days at the week, all weeks up to surgery.
다른 이름들:
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다른: Conventional care
Currently patients do not receive exercise (walk)-prescription before non cardiac surgery.
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Patient do not walk before surgery
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Length of stay
기간: Up 40 weeks in hospitalization
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Total stay hours
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Up 40 weeks in hospitalization
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Falls
기간: Up 40 weeks in hospitalization
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Fall event reported in patients´ charts
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Up 40 weeks in hospitalization
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Ischemic events
기간: Up 40 weeks in hospitalization
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Myocardial infarction or stroke
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Up 40 weeks in hospitalization
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Time to the first walk
기간: Up 40 weeks in hospitalization
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First time out of the bed registered in patients´charts
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Up 40 weeks in hospitalization
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공동 작업자 및 조사자
수사관
- 수석 연구원: Olga Cortés, PI, Fundación Cardioinfantil Instituto de Cardiología
간행물 및 유용한 링크
일반 간행물
- Mayo NE, Feldman L, Scott S, Zavorsky G, Kim DJ, Charlebois P, Stein B, Carli F. Impact of preoperative change in physical function on postoperative recovery: argument supporting prehabilitation for colorectal surgery. Surgery. 2011 Sep;150(3):505-14. doi: 10.1016/j.surg.2011.07.045.
- Carli F, Charlebois P, Stein B, Feldman L, Zavorsky G, Kim DJ, Scott S, Mayo NE. Randomized clinical trial of prehabilitation in colorectal surgery. Br J Surg. 2010 Aug;97(8):1187-97. doi: 10.1002/bjs.7102.
- Santa Mina D, Scheede-Bergdahl C, Gillis C, Carli F. Optimization of surgical outcomes with prehabilitation. Appl Physiol Nutr Metab. 2015 Sep;40(9):966-9. doi: 10.1139/apnm-2015-0084. Epub 2015 May 13.
- Cortes OL, Herrera-Galindo M, Becerra C, Rincon-Roncancio M, Povea-Combariza C, Esparza-Bohorquez M. Preoperative walking recommendation for non-cardiac surgery patients to reduce the length of hospital stay: a randomized control trial. BMC Sports Sci Med Rehabil. 2021 Jul 28;13(1):80. doi: 10.1186/s13102-021-00317-w.
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 연구와 관련된 용어
기타 연구 ID 번호
- CEIC-2224-2015
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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. .
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