## Protocol Section
### Identification Module
**NCT ID:** NCT06432972

**Acronym:** PREHAB

**Brief Title:** Accelerated Pulmonary Rehabilitation in the Preoperative Period

**Official Title:** Accelerated Pulmonary Rehabilitation in the Preoperative Period

#### Organization Study ID Info
**ID:** STUDY00002705
#### Organization
**Class:** OTHER
**Full Name:** University of Vermont
#### Secondary ID Infos
**Domain:** American Lung Association
**ID:** 1143233
**Type:** OTHER_GRANT
### Status Module
#### Completion Date
**Date:** 2025-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-24

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-02

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-29
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Vermont

#### Responsible Party

**Investigator Affiliation:** University of Vermont

**Investigator Full Name:** Katherine Menson

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- Chronic Obstructive Pulmonary Disease

- Lung Cancer Stage I

- Lung Cancer Stage II

- Lung Cancer Stage III

**Keywords:**

- Pulmonary Rehab

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Pulmonary Rehab

**Label:** Prehab

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Prehab

**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.

**Name:** Pulmonary Rehab

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Acceptability and feasibility will be documented by percent of those eligible enrolling in the study.

**Measure:** Proportion of patients determined eligible who enroll in the study

**Time Frame:** Through study completion, approximately 2 years

**Description:** Acceptability and feasibility will be determined by the proportion of pulmonary rehab sessions completed during this condensed pulmonary rehab program

**Measure:** Average Pulmonary Rehab sessions completed

**Time Frame:** The 14 day (up to 21 day) intervention period

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** olivia.johnson@uvmhealth.org

**Name:** Olivia J Garrow, MS, RDN

**Phone:** 802-847-2160

**Role:** CONTACT

**Contact 2:**

**Email:** sophie.macner@uvmhealth.org

**Name:** Sophie Macner

**Phone:** 802-847-2193

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Burlington

**Contacts:**

***Contact 1:***

- **Email:** olivia.johnson@uvmhealth.org

- **Name:** Olivia J Garrow, MS, RDN

- **Phone:** 802-847-2160

- **Role:** CONTACT

***Contact 2:***

- **Email:** sophie.macner@uvmhealth.org

- **Name:** Sophie Macner, BS

- **Phone:** 802-847-2193

- **Role:** CONTACT

***Contact 3:***

- **Name:** Katherine Menson, DO

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 4:***

- **Name:** Anne Dixon, MD

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** Abraham Sender, PA-C

- **Role:** SUB_INVESTIGATOR

***Contact 6:***

- **Name:** Hannah Kooperkamp, MD

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** University of Vermont Medical Center

**State:** Vermont

**Status:** RECRUITING

**Zip:** 05401

## Document Section

### Large Document Module

#### Large Docs

- Date: 2024-05-14

- Filename: Prot_SAP_000.pdf

- Has ICF: False

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol and Statistical Analysis Plan

- Size: 601853

- Type Abbrev: Prot_SAP

- Upload Date: 2024-05-24T14:57

- Date: 2024-05-14

- Filename: ICF_001.pdf

- Has ICF: True

- Has Protocol: False

- Has SAP: False

- Label: Informed Consent Form

- Size: 374554

- Type Abbrev: ICF

- Upload Date: 2024-05-24T14:57

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012142

- Term: Respiratory Tract Neoplasms

- ID: D000013899

- Term: Thoracic Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11172

- Name: Lung Neoplasms

- Relevance: HIGH

- As Found: Lung Cancer

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: HIGH

- As Found: Obstructive Pulmonary Disease

- ID: M23449

- Name: Pulmonary Disease, Chronic Obstructive

- Relevance: HIGH

- As Found: Chronic Obstructive Pulmonary Disease

- ID: M14979

- Name: Respiratory Tract Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16658

- Name: Thoracic Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008175

- Term: Lung Neoplasms

- ID: D000008173

- Term: Lung Diseases, Obstructive

- ID: D000029424

- Term: Pulmonary Disease, Chronic Obstructive

### Misc Info Module

- Version Holder: 2024-05-31
