Accelerated Pulmonary Rehabilitation in the Preoperative Period
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Vermont
About this trial
This proposed project will be a single arm, non-masked study. Participants who are actively smoking with a diagnosis of a new lung nodule, either confirmed or suspicious for lung cancer, with a plan for lung cancer treatment with or without surgical resection will be recruited from the University of Vermont Medical Center (UVMMC)pulmonary, cardiothoracic surgery, and Lung Multidisciplinary Clinic (LMDC). All patients will be enrolled in prehab and offered smoking cessation therapy. The acceptability and feasibility of this intervention will be measured by percent enrollment in study, attendance, barriers to completion, and monitoring of adverse events. The effect of prehab will be measured by traditional metrics, including fitness, respiratory symptoms, and depression scale. Research outcomes will be measured by smoking habits, anxiety, and surgical complications.
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Lung nodule that is deemed highly suspicious for lung cancer based on: nodule characteristics, risk factors, CT-PET avidity, previous biopsy results, and assessment by physicians specializing in lung cancers
Eligible for treatment
Current cigarette smoking ≥5 cigarettes per day
Disqualifiers
Unable to safely participate in PR due to unstable cardiac disease, unstable peripheral vascular disease, musculoskeletal disease that would prevent exercise, significant psychiatric or neurocognitive disease that would limit ability to exercise safely in a group setting as determined by the study physician and/or treatment physicians
Inability to consistently attend PR during treatment
Pregnancy, per patient self-report
Active or recent participation in another clinical trial that, in the opinion of the investigator would impact outcomes measured in this study
Trial design
Design model
Single group
Treatments tested in this trial
Pulmonary Rehab
Other interventionPrehab will include 2, one-hour sequential sessions of PR/day, however this intervention will increase the frequency from standard 2 days/week up to 4 days/week, while initiating treatment or awaiting surgery but not exceed 4 weeks, thus completing 16 sessions prior to surgery. An exercise prescription will be written by the medical director based on initial 6MWD, age, height, weight, and co-morbidities, per SOC.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: PrehabExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients determined eligible who enroll in the study
Acceptability and feasibility will be documented by percent of those eligible enrolling in the study.
Time frame
Through study completion, approximately 2 years2
Average Pulmonary Rehab sessions completed
Acceptability and feasibility will be determined by the proportion of pulmonary rehab sessions completed during this condensed pulmonary rehab program
Time frame
The 14 day (up to 21 day) intervention periodSponsors and contacts
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Source ClinicalTrials.gov