Accelerated Pulmonary Rehabilitation in the Preoperative Period

NCT06432972 | Recruiting DMC

• 2 other identifiers: STUDY000027051143233
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Pulmonary Rehab

Outcome Measures

Primary Outcomes (2)

• 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.

  Through study completion, approximately 2 years

• 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

  The 14 day (up to 21 day) intervention period

Study Arms (1)

Prehab

EXPERIMENTAL

Other: Pulmonary Rehab

Interventions

Pulmonary Rehab OTHER

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.

Prehab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Neoplasms

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Central Study Contacts

Olivia J Garrow, MS, RDN

CONTACT

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

Sophie Macner

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 29, 2024
• Study Start: January 2, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (1)