Accelerated Pulmonary Rehabilitation in the Preoperative Period

Part of paid clinical trials in Burlington, Vermont.

Sponsor
University of Vermont
Study ID
NCT06432972
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jan 2, 2024
Status verified
Mar 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Prehab

Primary Outcome Measure

Proportion of patients determined eligible who enroll in the study [ Time Frame: Through study completion, approximately 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Vermont Medical CenterBurlingtonVermont05401
Olivia J Garrow, MS, RDN
[email protected]
802-847-2160
Sophie Macner, BS
[email protected]
802-847-2193
Katherine Menson, DO (PRINCIPAL_INVESTIGATOR)
Anne Dixon, MD (SUB_INVESTIGATOR)
Abraham Sender, PA-C (SUB_INVESTIGATOR)
Hannah Kooperkamp, MD (SUB_INVESTIGATOR)

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By research site
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