Recruiting

Pulmonary Rehabilitation

Sponsor:

University of Vermont

Code:

NCT06432972

Conditions

Chronic Obstructive Pulmonary Disease

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pulmonary Rehab

Study Details

Brief summary:

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.

Conditions

Chronic Obstructive Pulmonary Disease

Lung Cancer

Study ID

NCT06432972

Start date

Jan 2, 2024

Status verified date

Mar, 2026

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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
  • Willing to attempt smoking cessation during prehab period
  • Willing to take nicotine replacement therapy (NRT) and varenicline
  • Able to attend PR at UVMMC for 2, one-hour sequential sessions for a total of 16 sessions over 8 days during treatment
  • Willing and able to provide informed consent; ability determined by study physician and/or LMDC treatment physicians

Exclusion Criteria:

  • 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
  • Any other condition in the opinion of the investigator/study physician and or treatment physicians that would jeopardize patient safety or integrity of research results

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Prehab

Interventions

Pulmonary Rehab

Prehab 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.

Primary outcome measure

  • Proportion of patients determined eligible who enroll in the study [ Time Frame: Through study completion, approximately 2 years ]
  • Average Pulmonary Rehab sessions completed [ Time Frame: The 14 day (up to 21 day) intervention period ]

Central Contacts and Locations

Central contacts

Olivia J Garrow, MS, RDN

802-847-2160olivia.johnson@uvmhealth.org

Sophie Macner

802-847-2193sophie.macner@uvmhealth.org

Locations

University of Vermont Medical Center

Recruiting

Burlington, Vermont, United States, 05401

Contacts

Olivia J Garrow, MS, RDN

802-847-2160olivia.johnson@uvmhealth.org

Sophie Macner, BS

802-847-2193sophie.macner@uvmhealth.org

Principal Investigator:

Katherine Menson, DO

More Information

Sponsor

University of Vermont

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Keywords

  • Pulmonary Rehab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Vermont on 2026-03-23.