- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03162718
A Feasibility Study of Unsupervised, Pre-operative Exercise Program for Patients Scheduled for Lung Cancer Surgery
The paradigm of pre-operative exercise as a neoadjuvant therapy to reduce morbidity is increasingly promoted within general surgery and surgical oncology.
Patients with lung cancer participating in pre-operative exercise have better aerobic capacity and pulmonary function and shorter hospital length-of-stay after surgery. Additionally, pre-operative exercise may increase the likelihood of resuming exercise post-surgery, thereby accelerating the pace of rehabilitation and recovery.
In order to translate the research findings into sustainable clinical practice, clinician-scientists need to develop pragmatic and effective home-based exercise protocols. Wearable fitness devices offer a way to approximate the supervision that occurs in exercise research.
Before the investigators can develop an intervention in which patients receive tailored support similar to what occurs with supervised exercise, they need to pilot test the monitoring aspect of the wearable fitness device in conjunction with the pre-operative exercise program. The investigators propose a mixed methods, 16 single arm feasibility study of an unsupervised, pre-operative exercise prescription (uPEP) augmented by a wearable fitness device. The proposed study of 30 patients scheduled for lung cancer surgery will identify the strengths, weaknesses, and utility of this approach.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
New Hampshire
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Lebanon, New Hampshire, 미국, 03756
- Dartmouth-Hitchcock Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
This study will recruit English-speaking patients who:
- Are over the age of 18 and diagnosed with Stage I-III lung cancer;
- Are able to tolerate surgery (i.e., segmentectomy, lobectomy or bilobectomy) as indicated by standard clinical pre-op evaluation, including pulmonary function tests and cardiac evaluation (if indicated);
- Access to either Wi-Fi or cellular service and permission/ability to download the wearable fitness device app on an apple device, android, or computer (or willingness to use a study-provided iPod to allow the data to be uploaded to the study team);
- Are able to provide voluntary, written consent.
Exclusion Criteria:
Participants will be excluded based on electronic health record (EHR) review (after obtaining HIPAA waiver) if they:
- Have a life expectancy of < 12 months or are receiving hospice services;
- Have a psychiatric diagnosis that would require significant study modification to meet their needs such as uncontrolled severe mental illness, substance abuse, or active suicidal ideation;
- Exhibit American College of Sports Medicine contraindications to exercise which include a resting heart rate of >120bpm, blood pressure >180/100mmHg or unstable angina;31
- Are unable to walk or to complete the 6-minute walk test. According to our current standard of care, those participants will be referred to physical therapy for evaluation and treatment and will be excluded from the study as unsupervised exercise would not be safe.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
다른: single arm
exercise
|
single arm feasibility study of an unsupervised, pre-operative exercise prescription (uPEP) augmented by a wearable fitness device.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Adherence to exercise:
기간: Time 3, day of surgery
|
number of completed pre-operative exercise sessions divided by number of prescribed sessions, according to exercise log
|
Time 3, day of surgery
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Feasibility of recruitment:
기간: Time 5, 16 weeks post-surgery
|
number of patients enrolled divided by number of patients eligible
|
Time 5, 16 weeks post-surgery
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Acceptance of technology
기간: Time 3, day of surgery
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number of hours the fitness tracker was worn in pre-operative period
|
Time 3, day of surgery
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Participant perception of exercise program
기간: Time 2, 3-5 days before surgery
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semi-structured interview regarding perceptions of the exercise program
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Time 2, 3-5 days before surgery
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Participant perception of fitness tracker
기간: Time 2, 3-5 days before surgery
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semi-structured interview regarding perceptions of the fitness tracker
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Time 2, 3-5 days before surgery
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Subjective minutes spent in exercise
기간: Time 3, day of surgery
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Number of minutes spent in exercise according to exercise log
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Time 3, day of surgery
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Objective minutes spent in exercise:
기간: Time 3, day of surgery
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Number of minutes spent in exercise according to fitness tracker
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Time 3, day of surgery
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Aerobic capacity:
기간: Time 3, day of surgery
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Six minute walk test
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Time 3, day of surgery
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Pulmonary function:
기간: Time 2, 3-5 days before surgery
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Diffusion of lungs for carbon monoxide test
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Time 2, 3-5 days before surgery
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Subjective physical function:
기간: Time 2, 3-5 days before surgery
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PROMIS (Patient-Reported Outcomes Measurement Information System) physical function scale
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Time 2, 3-5 days before surgery
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Objective physical function:
기간: Time 3, day of surgery
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Grip strength per dynamometer
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Time 3, day of surgery
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Length of stay in hospital:
기간: Time 4, 2 weeks post-surgery
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Number of days from surgery to discharge home
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Time 4, 2 weeks post-surgery
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Feasibility of Retention
기간: 16 weeks post-surgery
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Number of patients completing all study assessments divided by the number enrolled
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16 weeks post-surgery
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공동 작업자 및 조사자
수사관
- 수석 연구원: Kathleen D Lyons, ScD, Dartmouth-Hitchcock Medical Center
- 수석 연구원: David J Finley, MD, Dartmouth-Hitchcock Medical Center
간행물 및 유용한 링크
일반 간행물
- Finley DJ, Stevens CJ, Emond JA, Batsis JA, Fay KA, Darabos C, Sacks OA, Cook SB, Lyons KD. Potential effectiveness of a surgeon-delivered exercise prescription and an activity tracker on pre-operative exercise adherence and aerobic capacity of lung cancer patients. Surg Oncol. 2021 Jun;37:101525. doi: 10.1016/j.suronc.2021.101525. Epub 2021 Mar 5.
- Finley DJ, Fay KA, Batsis JA, Stevens CJ, Sacks OA, Darabos C, Cook SB, Lyons KD. A feasibility study of an unsupervised, pre-operative exercise program for adults with lung cancer. Eur J Cancer Care (Engl). 2020 Jul;29(4):e13254. doi: 10.1111/ecc.13254. Epub 2020 May 29.
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. .
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