A Feasibility Study of Unsupervised, Pre-operative Exercise Program for Patients Scheduled for Lung Cancer Surgery
| Status: | Completed |
|---|---|
| Conditions: | Lung Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/7/2019 |
| Start Date: | September 14, 2017 |
| End Date: | February 5, 2019 |
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.
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.
The investigators propose a parallel mixed methods, 16 single arm, pre-post study with 30
participants scheduled for lung cancer surgery. At time of enrollment (at least 3 weeks
before their scheduled surgery), participants will complete baseline assessments, receive the
uPEP exercise prescription, and be oriented to the wearable fitness device. A research
assistant will call the participant to conduct an audiotaped semi-structured interview
regarding the acceptability of the electronically-monitored uPEP within 7- 14 days of
enrollment. The study team will complete follow-up assessments on the day of surgery, two
weeks after surgery, and four months after surgery. Data will also be collected from chart
review and the wearable fitness device throughout the study.
participants scheduled for lung cancer surgery. At time of enrollment (at least 3 weeks
before their scheduled surgery), participants will complete baseline assessments, receive the
uPEP exercise prescription, and be oriented to the wearable fitness device. A research
assistant will call the participant to conduct an audiotaped semi-structured interview
regarding the acceptability of the electronically-monitored uPEP within 7- 14 days of
enrollment. The study team will complete follow-up assessments on the day of surgery, two
weeks after surgery, and four months after surgery. Data will also be collected from chart
review and the wearable fitness device throughout the study.
Inclusion Criteria:
- This study will recruit English-speaking patients who:
1. Are over the age of 18 and diagnosed with Stage I-III lung cancer;
2. 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);
3. 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);
4. 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:
1. Have a life expectancy of < 12 months or are receiving hospice services;
2. 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;
3. 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
4. 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.
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