이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Perioperative Rehabilitation in Operation for Lung Cancer (PROLUCA)

2015년 5월 5일 업데이트: Jesper Holst Pedersen, Rigshospitalet, Denmark

Background: Improved surgical techniques combined with effective adjuvant chemotherapy, has led to a better survival in individuals with NSCLC. The treatment of NSCLC and other cancer diseases are after all still complex and potentially lethal.

Study aim: The rationale for the study PROLUCA is to identify the optimal timing of exercise to improve recovery after surgery in patients operated for lunge cancer with focus on physical capacity and quality of life.

Who can participate? Patients above 18 years and diagnosed with lung cancer and referred for operation. Participation in this study is not possible if the participants by a doctor are advised not to do strenuous exercise.

What does the study involve? The intervention consists of a combination of (1) exercise before surgery and (2) exercise after surgery for lung cancer.

  1. Exercise before surgery is a home-based exercise program is individually designed and must be performed for at least 30 minutes every day until surgery. The home-based exercise program varies in length due to number of days until surgery, and the intention is not exceed 14 days.
  2. The exercise initiated two weeks and 6 weeks after surgery consists of a 12 weeks rehabilitation program and three individual counseling sessions. Special needs in terms of smoking cessation, nutritional counseling or patient education, this is also offered. The exercise consists of individually prepared supervised strength - and fitness exercise in a team, two sessions of 60 minutes/week.

What interventions will be compared? A home-based post-operative exercise program, combined with exercise initiated two weeks after surgery, will be compared with usual care (exercise initiated six weeks after surgery).

Will all participants receive the same treatment?

By draw it is decided which of the 4 groups the participants will attend to in the study:

  • Group 1: Home-based exercise before surgery and rehabilitation initiated as early as two weeks after surgery
  • Group 2: Home-based exercise before surgery and rehabilitation initiated six weeks after surgery
  • Group 3: Rehabilitation initiated as early as two weeks after surgery
  • Group 4: Rehabilitation initiated six weeks after surgery (Usual practice as control group) What are the possible benefits and risks of participating? There are no risks or side- effects of participating other than muscle soreness and exercise is beneficial when it comes to recover from an operation from lung cancer.

연구 개요

상태

종료됨

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

40

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 덴마크
    • Nørrebro
      • Copenhagen, Nørrebro, 덴마크, DK-2200
        • Copenhagen Centre for Cancer and Health

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

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Performance status 0-2 (WHO)
  • Living in the City of Copenhagen or surrounding Municipalities
  • Ability to read and understand Danish
  • Approval by primary surgeon

Exclusion Criteria:

  • Presence of metastatic disease or surgical inoperability
  • Diagnosis of Lung Cancer not verified by histological diagnosis
  • Cardiac disease

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 1. Experimental
Home-based exercise pre surgery and postoperative exercise in a team initiated two weeks after surgery.
행동: Experimental: 1. Experimental

Home-based exercise pre surgery and postoperative exercise in a team initiated two weeks after surgery. Intervention consists of:

  1. Preoperative home-based exercise program - cardiovascular exercise of moderate-vigorous intensity for at least 30 minutes every day until surgery.
  2. Postoperative rehabilitation: A supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions and smoking cessation, nutritional counseling or patient education, this is offered too.The cardiorespiratory intensity is at ~50-60% of individual HRmax for the first four weeks and increases to moderate-high intensity at ~70-90% of individually determined HRmax. The intensity of the strength exercise program is at ~60-80% of 1 RM.
다른 이름들:
  • Preoperative and early postoperative rehabilitation
실험적: 2. Experimental
Home-based exercise pre surgery and postoperative exercise in a team initiated six weeks after surgery.
행동: Experimental: 2. Experimental

Home-based exercise pre surgery and postoperative exercise in a team initiated six weeks after surgery. Intervention consists of:

  1. Preoperative home-based exercise program - cardiovascular exercise of moderate-vigorous intensity for at least 30 minutes every day until surgery.
  2. Postoperative rehabilitation: A supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions and smoking cessation, nutritional counseling or patient education, this is offered too.The cardiorespiratory intensity is at ~50-60% of individual HRmax for the first four weeks and increases to moderate-high intensity at ~70-90% of individually determined HRmax. The intensity of the strength exercise program is at ~60-80% of 1 RM.
다른 이름들:
  • Preoperative and late postoperative rehabilitation
실험적: 3. Experimental
Exercise in a team initiated two weeks after surgery.
행동: Experimental: 3. Experimental

Early postoperative exercise in a team initiated two weeks after surgery. Intervention consists of:

Postoperative rehabilitation: A supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions and smoking cessation, nutritional counseling or patient education, this is offered too.The cardiorespiratory intensity is at ~50-60% of individual HRmax for the first four weeks and increases to moderate-high intensity at ~70-90% of individually determined HRmax. The intensity of the strength exercise program is at ~60-80% of 1 RM.

다른 이름들:
  • Early postoperative rehabilitation alone
다른: 4. Usual care
Exercise in a team initiated six weeks after surgery.
행동: Other: 4. Usual care

Exercise in a team initiated six weeks after surgery consisting of a supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions, and three group-based lessons in health-promoting behavior. If the participants have special needs in terms of smoking cessation, nutritional counseling or patient education, this is offered too.

The cardiorespiratory intensity is at ~50-60% of individual HRmax for the first four weeks. The next eight weeks the intensity increases to moderate-high intensity at ~70-90% of individually determined HRmax. The intensity of the strength exercise program is at ~60-80% of 1 RM.

다른 이름들:
  • 평소 케어

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Maximum oxygen uptake (VO2peak)
기간: VO2peak is assessed at baseline, the day before surgery, post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.
VO2peak is evaluated by an incremental test using an electromagnetically braked cycle ergometer (Lode Corival Ergometer©). Inspired and expired gases are analyzed breath-by-breath by a metabolic cart (JAEGER MasterScreen CPX©). Subjects begin pedaling at seven watts and resistance increases after a predefined 10 watts ramp protocol until exhaustion or a symptom-limited VO2peak is achieved (pain, dizziness, anxiety etc.).
VO2peak is assessed at baseline, the day before surgery, post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.

2차 결과 측정

결과 측정
측정값 설명
기간
Six minute walk distance (6MWD)
기간: baseline, the day before surgery, pre-intervention (2/6 weeks after surgery), post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.
baseline, the day before surgery, pre-intervention (2/6 weeks after surgery), post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.
Patient reported outcomes (PROs)
기간: Baseline, the day before surgery, pre-intervention (2/6 weeks after surgery), post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.
PROs will include health related quality of life, symptoms and side-effects, anxiety and depression, well-being, distress, lifestyle, sickness absence, work status, and social support.
Baseline, the day before surgery, pre-intervention (2/6 weeks after surgery), post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.
Pulmonary function
기간: Baseline, the day before surgery, post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.
forced expiratory volume at one second
Baseline, the day before surgery, post-intervention (14/18 weeks after surgery), six months after surgery, and one year after surgery.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Rigshospitalet, Denmark

협력자

Novo Nordisk A/S
University of Copenhagen
Danish Cancer Society
Centre for Integrated Rehabilitation of Cancer patients, CIRE, Denmark
Copenhagen Centre for Cancer and Health, Denmark.

수사관

  • 연구 의자: Jesper Holst Pedersen, MD, DrMSci, Department of Cardiothoracic Surgery RT
  • 연구 책임자: Jette Vibe-Petersen, MD, Copenhagen Centre for Cancer and Health
  • 수석 연구원: Maja Schick Sommer, MHS, Copenhagen Centre for Cancer and Health

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

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

2012년 5월 1일

기본 완료 (실제)

2014년 10월 1일

연구 완료 (실제)

2015년 1월 1일

연구 등록 날짜

최초 제출

2013년 6월 20일

QC 기준을 충족하는 최초 제출

2013년 7월 2일

처음 게시됨 (추정)

2013년 7월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2015년 5월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2015년 5월 5일

마지막으로 확인됨

2015년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • PROLUCA
  • 2007-58-0015 (Danish Data Protection Agency)

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. .

폐암에 대한 임상 시험

Experimental: 1. Experimental에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

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정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다