The benefits of pulmonary rehab (PR) prior to lung resection have not been well-studied
in the population that could benefit from it the most, patients with COPD who smoke. This
study would be innovative in two major ways. First, the impact of prehab in those who
smoke could be established. Secondly, the optimal model of prehab, which meets the
clinical needs of the patient in the pre-surgical window, and aligns with the current
model of PR, could be determined.
Screening and Recruitment Investigators estimate that 20 participants over a two-year
period will be sufficient to measure the safety and feasibility of this study.
Investigators aim to enroll, on average, 2 participants per month in order to complete
this study in a timely fashion. Participants will be enrolled in prehab on a rolling
basis, as to not delay surgical timeline.
Some procedures will be performed as a component of standard of care and some will be for
research purposes only. This distinction is outlined in the sections below.
Intake and Baseline Assessment After informed consent, participants will complete the
initial assessment with study coordinator. This will include anthropometrics,
demographics like age, sex, race and ethnicity, and other sociodemographic and economic
characteristics such as education, marital status, income, etc. This assessment will also
include thorough medical, and surgical review, healthcare resource utilization,
medication usage, substance use and smoking history, specifically recall of average
cigarettes per day, carbon monoxide measurements, Fagerström nicotine dependence scale,
and readiness to change. Investigators will also administer the General Anxiety
Disorder-7 (GAD-7) questionnaire to assess for anxiety. Following intake, participants
will be enrolled in the prehab program, which will include standard of care intake
measurements including 6-minute walk distance (6MWD), mMRC, SGRQ, short physical
performance battery (SPPB), and PHQ-9. For ease of the patient, Investigators will offer
that this be performed on the same day, in a private medical setting at the PR facility.
If the patient chooses, Investigators can offer intake at the Vermont Lung Center on a
separate day.
Prehab Prehab will include 2, one-hour sequential sessions of PR per day as is standard,
however this intervention will increase the frequency from 2 days to 4 days per week, for
2 weeks, thus completing 16 sessions of PR prior to or in the early stages of treatment.
An exercise prescription will be written by the medical director based on initial 6MWD,
age, height, weight, and co-morbidities, as is standard of care. Prior to each session,
patients are evaluated for symptoms and vital signs are measured. Exercise will include
30 minutes of warm-up and upper and lower extremity resistance training, either against
gravity or with resistance bands as appropriate. Exercise will then move to the open gym,
where patients utilize endurance equipment of their choosing, such as a treadmill or
recumbent bicycle. As with traditional PR, participants will be given online education
videos regarding lung health to complete at home, with a supplementary video on breathing
techniques to reduce atelectasis from pain. Virtual synchronous home-based PR will be
offered to patients who have barriers to in-center PR.
Smoking Cessation Intervention Regarding smoking cessation, patients will be offered and
prescribed the gold standard therapies in an attempt at smoking cessation, including a
one-hour individual counseling session with a mental health therapist trained in smoking
cessation therapy, varenicline treatment, dual acting NRT, and referral to the state
smoking cessation program. Education modules on the benefits of smoking cessation will
also be created for participants to review in the education portion of prehab. None of
these interventions will be required, but offered as is standard of care.
Assessments Post-Prehab and 30 Days Post-Treatment Following completion of prehab prior
to lung resection surgery Pulmonary Rehabilitation standard of care assessments and
research-based assessments will be repeated. This will include interim health history,
healthcare resource utilization, and medication usage, assessment for adverse events and
COPD exacerbations, substance use and smoking status including recall of average
cigarettes per day, carbon monoxide measurements, Fagerström nicotine dependence scale,
readiness to change, GAD-7 and the study evaluation. 30 days following lung cancer
treatment, the study team will review the participants medical record for any adverse
events.