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.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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New Hampshire
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Lebanon、New Hampshire、美国、03756
- Dartmouth-Hitchcock Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：single arm
exercise
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single arm feasibility study of an unsupervised, pre-operative exercise prescription (uPEP) augmented by a wearable fitness device.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Adherence to exercise:
大体时间：Time 3, day of surgery
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number of completed pre-operative exercise sessions divided by number of prescribed sessions, according to exercise log
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Time 3, day of surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Feasibility of recruitment:
大体时间：Time 5, 16 weeks post-surgery
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number of patients enrolled divided by number of patients eligible
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Time 5, 16 weeks post-surgery
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Acceptance of technology
大体时间：Time 3, day of surgery
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number of hours the fitness tracker was worn in pre-operative period
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Time 3, day of surgery
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Participant perception of exercise program
大体时间：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
大体时间：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
大体时间：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:
大体时间：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:
大体时间：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:
大体时间：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:
大体时间：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:
大体时间：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:
大体时间：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
大体时间：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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合作者和调查者
调查人员
- 首席研究员：Kathleen D Lyons, ScD、Dartmouth-Hitchcock Medical Center
- 首席研究员：David J Finley, MD、Dartmouth-Hitchcock Medical Center
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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肺癌的临床试验
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Exercise的临床试验
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University of Maryland, BaltimoreNational Institute on Aging (NIA)完全的