Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
NCT Number: NCT03162718
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Lebanon, New Hampshire, 03756, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
single arm feasibility study of an unsupervised, pre-operative exercise prescription (uPEP) augmented by a wearable fitness device.
Time frame: Time 3, day of surgery
number of completed pre-operative exercise sessions divided by number of prescribed sessions, according to exercise log
Time frame: Time 5, 16 weeks post-surgery
number of patients enrolled divided by number of patients eligible
Time frame: Time 3, day of surgery
number of hours the fitness tracker was worn in pre-operative period
Time frame: Time 2, 3-5 days before surgery
semi-structured interview regarding perceptions of the exercise program
Time frame: Time 2, 3-5 days before surgery
semi-structured interview regarding perceptions of the fitness tracker
Time frame: Time 3, day of surgery
Number of minutes spent in exercise according to exercise log
Time frame: Time 3, day of surgery
Number of minutes spent in exercise according to fitness tracker
Time frame: Time 3, day of surgery
Six minute walk test
Time frame: Time 2, 3-5 days before surgery
Diffusion of lungs for carbon monoxide test
Time frame: Time 2, 3-5 days before surgery
PROMIS (Patient-Reported Outcomes Measurement Information System) physical function scale
Time frame: Time 3, day of surgery
Grip strength per dynamometer
Time frame: Time 4, 2 weeks post-surgery
Number of days from surgery to discharge home
Time frame: 16 weeks post-surgery
Number of patients completing all study assessments divided by the number enrolled
Dartmouth-Hitchcock Medical Center
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06003335
Behavior, Cancer-related Cognitive Impairment
Hong Kong
View Trial DetailsNCT07591376
Behavior, Lung Cancer
Vejle, Denmark
View Trial DetailsNCT03724331
Behavior, Bronchial Neoplasms
Omaha, Nebraska, United States
View Trial DetailsNCT02493114
Behavior, Exercise Capacity
Genk, Belgium
View Trial Details