Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432972
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-13
Brief Title:
Accelerated Pulmonary Rehabilitation in the Preoperative Period
Sponsor:
University of Vermont
Organization:
University of Vermont
Study Overview
Official Title:
Accelerated Pulmonary Rehabilitation in the Preoperative Period
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREHAB
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1143233 | OTHER_GRANT | American Lung Association | None |