Pulmonary Rehab for COPD and Lung Cancer

(PREHAB Trial)

Overseen By Olivia J Garrow, MS, RDN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Vermont

Must be taking: Nicotine replacement, Varenicline

Disqualifiers: Unstable cardiac, Musculoskeletal, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 18

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, you will need to be willing to take nicotine replacement therapy and varenicline as part of the study.

What data supports the effectiveness of the treatment Pulmonary Rehabilitation for COPD and Lung Cancer?

Pulmonary rehabilitation can improve the quality of life and ability to function for patients with chronic obstructive pulmonary disease (COPD), and it may also reduce hospital admissions. This suggests that similar benefits might be seen in patients with lung cancer, although specific studies on lung cancer are not mentioned. ^{1 2 3 4 5}

Is pulmonary rehabilitation safe for humans?

Pulmonary rehabilitation is generally considered safe for people with chronic respiratory diseases like COPD and lung cancer. It is a non-medication therapy that helps improve exercise tolerance and quality of life without significant safety concerns reported in the studies. ^{2 4 6 7 8}

How is pulmonary rehabilitation different from other treatments for COPD and lung cancer?

Pulmonary rehabilitation is unique because it is a non-drug treatment that combines exercise, education, and support to improve lung function and quality of life. Unlike medications, it focuses on enhancing physical fitness and overall well-being, making it especially beneficial for patients preparing for or recovering from lung surgery. ^{7 9 10 11 12}

Eligibility Criteria

This trial is for individuals who are currently smoking, have been diagnosed with COPD (Chronic Obstructive Pulmonary Disease), and either confirmed or suspected lung cancer with plans for surgery. They must be patients at the University of Vermont Medical Center and willing to undergo prehabilitation and consider quitting smoking.

Inclusion Criteria

I am willing to try to quit smoking before treatment starts.

I am willing and able to agree to participate in the study as confirmed by the study doctor.

My lung nodule is highly likely to be cancer, as determined by specialists.

Exclusion Criteria

I have health conditions that prevent me from safely doing exercises in a group.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intake and Baseline Assessment

Participants complete initial assessments including anthropometrics, demographics, medical and surgical review, and anxiety assessment

1 day

1 visit (in-person)

Prehab

Participants undergo accelerated pulmonary rehabilitation with increased frequency, including exercise sessions and smoking cessation interventions

2-3 weeks

16 sessions (in-person or virtual)

Post-Prehab Assessment

Standard of care and research-based assessments are repeated to evaluate health status and smoking cessation progress

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness 30 days post-treatment, including review of medical records for adverse events

4 weeks

Treatment Details

Interventions

• Pulmonary Rehabilitation

Trial Overview The study tests a pulmonary rehabilitation program before surgery in smokers with COPD and lung nodules. It aims to see if this 'prehab' can improve fitness, respiratory symptoms, depression, reduce anxiety, change smoking habits, and decrease surgical complications.

Participant Groups

Group I: Prehab Experimental Treatment 1 Intervention

Pulmonary Rehabilitation is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Pulmonary Rehabilitation for:

• Chronic Obstructive Pulmonary Disease (COPD)
• Idiopathic Pulmonary Fibrosis (IPF)
• Interstitial Lung Diseases (ILDs)

Approved in United States as Pulmonary Rehabilitation for:

• COPD
• IPF
• ILDs
• Pulmonary Hypertension
• Cystic Fibrosis

Approved in Canada as Pulmonary Rehabilitation for:

• COPD
• IPF
• ILDs

Approved in Japan as Pulmonary Rehabilitation for:

• COPD
• IPF
• ILDs

Who Is Running the Clinical Trial?

University of Vermont

Lead Sponsor

Trials

283

Recruited

3,747,000+

Findings from Research

Qualitative interviews with 16 patients with COPD revealed that fears about breathlessness and exercise were significant barriers to accepting pulmonary rehabilitation, while the potential to regain control over their health motivated participation.

A proposed model suggests that framing pulmonary rehabilitation as a means to regain control may help address patients' concerns and improve their willingness to engage in the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the uptake of pulmonary rehabilitation in patients with COPD: qualitative study of experiences and attitudes. Harris, D., Hayter, M., Allender, S.[2018]

In a study of 437 COPD patients undergoing a 12-week intensive pulmonary rehabilitation program, significant improvements were observed in both exercise performance and health-related quality of life, with 68% of patients showing enhanced walking distance and 75% reporting better quality of life post-rehabilitation.

Despite the severe health impairments of the patients, the study indicates that pulmonary rehabilitation can lead to substantial benefits, although individual responses to the program were not easily predictable based on initial health status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of pulmonary rehabilitation in COPD patients with severely impaired health status. van Ranst, D., Otten, H., Meijer, JW., et al.[2021]

Pulmonary rehabilitation is a crucial treatment for chronic obstructive pulmonary disease (COPD) that significantly improves patients' quality of life.

The review highlights various rehabilitation methods that can enhance health outcomes for COPD patients, emphasizing the importance of tailored approaches in managing the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Quality of life outcomes of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease (COPD)]. Kasibowska-Kuźniar, K., Jankowska, R., Kuźniar, T.[2007]

The pulmonary rehabilitation (PR) program significantly improved exercise capacity in COPD patients, with an average increase of 263.8 feet in the 6-minute walk distance (6MWD) after participation.

The program also led to a reduction in the frequency of COPD exacerbations by 0.3 events per year, indicating a positive impact on overall health, although quality-of-life improvements were mixed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary Rehabilitation: A Retrospective Study in Eastern North Carolina. Chalise, SN., Shaheen, HT., Rizwan, MZ., et al.[2019]

A daily outpatient rehabilitation program for COPD patients showed significant improvements in most measured parameters, particularly in the 6-minute walking distance, which increased from an average of 485.78 m to 527.97 m after 19 days of rehabilitation.

The program was safe, with no adverse events reported, indicating that outpatient rehabilitation can be a viable and effective approach for managing COPD in an acute hospital setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preliminary Short-term Results of an All-day Outpatient Pulmonary Rehabilitation Program in an Acute Hospital on Patients with Mild to Very Severe COPD]. Spielmanns, M., Winkler, A., Priegnitz, C., et al.[2015]

Referral rates for pulmonary rehabilitation (PR) in patients with chronic obstructive pulmonary disease (COPD) are low, ranging from 0% to 85% across 42 studies, indicating a significant opportunity for improvement in patient care.

Healthcare professionals (HCPs) often cite a lack of knowledge about PR and its benefits, as well as the referral process, as major barriers to making referrals; however, training and experience in PR are seen as key enablers that could enhance referral rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of, and barriers and enablers to, pulmonary rehabilitation referral in COPD: A systematic scoping review. Milner, SC., Boruff, JT., Beaurepaire, C., et al.[2018]

Pulmonary rehabilitation is a comprehensive, non-medication intervention that has shown potential benefits for patients with chronic respiratory diseases, including those with lung cancer.

Preliminary studies indicate that pulmonary rehabilitation can improve exercise tolerance, enhance quality of life, and reduce surgical complications in lung cancer patients, suggesting it may be a valuable addition to their treatment plan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pulmonary rehabilitation in the management of patients with lung cancer]. Qiao, Y., Qiu, X., Zhou, Q.[2021]

Pulmonary rehabilitation significantly enhances muscle function and exercise tolerance in patients with chronic obstructive pulmonary disease (COPD), providing benefits that complement traditional medication.

A tailored, multidisciplinary approach is essential for effective pulmonary rehabilitation, but the challenge remains in sustaining these benefits once the program concludes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation. Troosters, T., Demeyer, H., Hornikx, M., et al.[2018]

Pulmonary rehabilitation is now considered the gold standard treatment for patients with severe lung diseases like COPD, helping to improve their overall condition and prepare them for more advanced therapies.

Randomized trials have shown that pulmonary rehabilitation is effective, and it should be offered to all patients with symptomatic respiratory disease, especially those being considered for high-risk surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic respiratory failure after lung resection: the role of pulmonary rehabilitation. Celli, BR.[2007]

Pulmonary rehabilitation significantly enhances performance, endurance, and quality of life for patients with chronic lung disease, while also reducing hospitalizations and length of hospital stays.

Patients who are motivated to quit smoking are the most likely to benefit from pulmonary rehabilitation, making them ideal candidates for this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation in Switzerland. Karrer, W.[2022]

Pulmonary rehabilitation, which includes physical training, education, and lifestyle changes, is an effective intervention for chronic respiratory disorders beyond just COPD, such as interstitial lung diseases and pulmonary hypertension.

Recent studies suggest that clinicians should consider pulmonary rehabilitation for a wide range of chronic lung conditions, including lung cancer and obesity, highlighting its versatility and potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Pulmonary rehabilitation in respiratory disorders other than COPD : an individualized approach]. Janssens, JP., Chappuis-Gisin, É., Maragkoudakis, C., et al.[2019]

Pulmonary rehabilitation (PR) significantly enhances exercise capacity, alleviates symptoms, and improves the quality of life for patients with Chronic Obstructive Pulmonary Disease (COPD), while also contributing to increased survival rates and reduced healthcare usage.

Patients with severe symptoms, low exercise capacity, and poor quality of life benefit the most from PR, which includes a multidisciplinary approach involving exercise training, education, and psychosocial support tailored to individual needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Rehabilitation in COPD]. Villiger, B.[2008]

References

1. England pubmed.ncbi.nlm.nih.gov

Improving the uptake of pulmonary rehabilitation in patients with COPD: qualitative study of experiences and attitudes. [2018]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Outcome of pulmonary rehabilitation in COPD patients with severely impaired health status. [2021]

3. Poland pubmed.ncbi.nlm.nih.gov

[Quality of life outcomes of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease (COPD)]. [2007]

4. United States pubmed.ncbi.nlm.nih.gov

Pulmonary Rehabilitation: A Retrospective Study in Eastern North Carolina. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

[Preliminary Short-term Results of an All-day Outpatient Pulmonary Rehabilitation Program in an Acute Hospital on Patients with Mild to Very Severe COPD]. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Rate of, and barriers and enablers to, pulmonary rehabilitation referral in COPD: A systematic scoping review. [2018]

7. China pubmed.ncbi.nlm.nih.gov

[Pulmonary rehabilitation in the management of patients with lung cancer]. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Chronic respiratory failure after lung resection: the role of pulmonary rehabilitation. [2007]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation in Switzerland. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

[Pulmonary rehabilitation in respiratory disorders other than COPD : an individualized approach]. [2019]

12. Switzerland pubmed.ncbi.nlm.nih.gov

[Rehabilitation in COPD]. [2008]