Trial Title:
Accelerated Pulmonary Rehabilitation in the Preoperative Period
NCT ID:
NCT06432972
Condition:
Chronic Obstructive Pulmonary Disease
Lung Cancer Stage I
Lung Cancer Stage II
Lung Cancer Stage III
Conditions: Official terms:
Lung Neoplasms
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Conditions: Keywords:
Pulmonary Rehab
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Pulmonary Rehab
Description:
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 surgery. 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.
Arm group label:
Prehab
Summary:
This proposed project will be a single arm, non-masked study. Participants who are
actively smoking with a diagnosis of COPD and new lung nodule, either confirmed or
suspicious for lung cancer, with a plan for surgical resection will be recruited from the
University of Vermont Medical Center (UVMMC) 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.
Detailed description:
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, surgical and COPD history 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 surgery. 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.
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- Lung Resection Surgery 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 resection surgery, the study team will review the participants medical record for
any adverse events.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age 18 years or older
- Physician diagnosis of COPD
- 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 LMDC physicians specializing in lung cancers
- Eligible for surgical resection
- Stage I, II, IIIa lung cancer with plan for lobectomy, pneumonectomy, or wedge
resection
- 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 in a 2-week time frame
- 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 LMDC
treatment physicians
- Ineligible for surgical resection (including suspicion for metastatic disease) as
determined by the study physician and/or LMDC treatment physicians
- Inability to consistently attend PR over a 2-week period
- 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 LMDC
treatment physicians that would jeopardize patient safety or integrity of research
results
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Vermont Medical Center
Address:
City:
Burlington
Zip:
05401
Country:
United States
Status:
Recruiting
Contact:
Last name:
Olivia J Garrow, MS, RDN
Phone:
802-847-2160
Email:
olivia.johnson@uvmhealth.org
Contact backup:
Last name:
Sophie Macner, BS
Phone:
802-847-2193
Email:
sophie.macner@uvmhealth.org
Investigator:
Last name:
Katherine Menson, DO
Email:
Principal Investigator
Investigator:
Last name:
Anne Dixon, MD
Email:
Sub-Investigator
Investigator:
Last name:
Abraham Sender, PA-C
Email:
Sub-Investigator
Investigator:
Last name:
Hannah Kooperkamp, MD
Email:
Sub-Investigator
Start date:
January 2, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
University of Vermont
Agency class:
Other
Source:
University of Vermont
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06432972
