Prehabilitation for Lung Cancer Patients Undergoing Lung Resection
- Conditions
- Lung CancerLung Resection
- Registration Number
- NCT06802627
- Lead Sponsor
- Universidade do Porto
- Brief Summary
Lung surgical resection is the gold standard treatment for earlier stages of lung cancer patients. Nevertheless, postoperative pulmonary complications (PPC) are frequent, related to morbidity and mortality, increasing length of hospital stay (LOS), hospital costs, delaying adjuvant treatments, and patients suffering. The PPC often occurs on postoperative days, even after hospital discharge. Prehabilitation might reduce PPC, although few studies have compared the effectiveness of different training protocols, and no information is available regarding the possible benefits of expiratory muscle training. Moreover, there are no comparisons of the cost-benefits of other protocols in patients submitted to lung resection surgery.
This project investigates the effectiveness of and compares four different prehabilitation protocols in reducing PPC and LOS in patients selected for lung cancer resections.
Participants will be individuals referred to surgical resection due to lung cancer. Patients who meet the inclusion criteria will be invited to participate in the study. After clinical data collection, patients will be randomly allocated (simple method) into four groups \[Control - CG, receiving an education session; Inspiratory muscle training group (IMT-G) receiving education session plus inspiratory muscle training (IMT); expiratory muscle training group (EMT-G) receiving education session plus expiratory muscle training (EMT); global exercise training group (GET-G) receiving education session plus a general exercise training (GET)\], and evaluated for functional capacity (pulmonary function, respiratory muscle function, physical fitness, daily physical activity, dyspnoea, fatigue, quality of life, anxiety, depression, and a 24-hour food diary. Afterward, all patients will receive an education class and written information regarding healthy habits to follow before, during, and after hospital discharge. Patients allocated to exercise groups will start the prehabilitation intervention for two weeks. After the intervention, patient assessments will be repeated. After that, patients will be submitted to surgery, and anesthetic and surgical procedure data will be collected. During hospital recovery, all patients will receive physiotherapy and any etiological complications and the LOS will be recorded according to medical criteria. After hospital discharge, PPC will be monitored and recorded for 30 days; by then, patients will be submitted to the final assessment.
- Detailed Description
To achieve the project's aim, sample size was calculated using G\*Power 3.1.9.2, based on an effect size of 0.33 reported by Cavalheri \& Granger (2017) in a study of preoperative exercise training and pulmonary complications after lung resection. With α = 0.05 and 95% power, a sample of 180 patients (45 per group) was determined. Accounting for a 10% dropout rate, the estimated total sample size is 200 patients.
The study was approved by the Ethical Committee from the Unidade Local de Saúde de São João (ULS São João), number (52/2024). All patients who meet the inclusion criteria, selected for pulmonary resections due to lung cancer, will be invited to participate in the study at the first preoperative appointment at the Cardiothoracic Department of the ULS São João. After signing the informed consent statement, a cod number will be attributed to the patients to protect his/her personal information. Participants will be randomized into one of the four groups: control group (CG), inspiratory muscle training group (IMT-G), expiratory muscle training group (EMT-G), and global exercise group (GET-G).
Assessments will be conducted at three time points: after obtaining written informed consent (baseline), after completing the prehabilitation program (post-intervention), and 30 days post-discharge (follow-up). Each assessment will take two days.
First day of assessments (data collection at the hospital):
A physician will carry one a medical assessment and collect data regarding anthropometric, sociodemographic, medical history, and behavioral risk factors. Following the medical assessment, a researcher will provide to the patients an accelerometer to measure daily physical activity. The accelerometers will be worn during waking hours until completing the prehabilitation program. Additionally, the researcher will collect data regarding patient-related outcome measures through questionaries (modified Medical Research Council Dyspnoea Questionnaire, International Physical Activity Questionnaire - Short Form, the Fatigue Assessment Scale, the Hospital Anxiety and Depression Scale, the EuroQol 5D-5L, food intake report from the day before (1-day recall)\]. Only in the baseline assessment, it will be placing the evaluation of barriers for prehabilitation. The researcher will then schedule the second day of assessment within the next three or four days.
Second day (data collection at Faculty of Sport of the University of Porto):
In the second day, patients will be evaluated for pulmonary function, respiratory muscle function, and functional capacity and physical fitness. Pulmonary function and respiratory muscle function will provide information on respiratory dynamics, including the absolute and predicted values of forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), peak expiratory flow (PEF), Tiffeneau index (TI); total lung capacity (TLC), diffusion lung capacity for carbon monoxide (DLCO) and DLCO per unit alveolar volume (DLCO/VA). Regarding respiratory muscle function, maximal voluntary ventilation (MVV), maximal inspiratory pressure (MIP), and maximal expiratory pressure (MEP) will be measured. Thereafter, patients will be assessed for functional capacity / physical fitness \[aerobic endurance (6-minute walk test); lower body strength (30-second sit to stand), agility, coordination and dynamic balance (time up and go), balance (3 balance positions), speed walk (4 meters), lower body power (5-time sit to stand), handgrip strength\].
One week after the acceptance in participating in the study, the intervention program will start with an in-person education session for all patients, and those from the IMT-G, EMT-G and GET-G will thereafter start their 2-week training interventions at ULS São João. Detailed information of the training interventions is described in the Arms and Interventions section.
Following the intervention, all patients will be reassessed using the same procedures as at baseline, and then they will undergo the surgery. Information on ASA classification, ARISCAT score, minimum oxygen saturation, surgical approach, total surgical time, and extent of resection will be registered by the surgical team.
After surgery, all patients will receive standard care at the Cardiothoracic Department, including daily medical assessment, physiotherapy care, and analgesic protocol. Postoperative pulmonary complications (PPC) or from any other etiology, as well as the length of hospital stay (LOS), will be recorded. Any postoperative complication and hospital readmission in the next 30 days will be monitored and recorded. The criteria of PPC will be established according to the European Society of Thoracic Surgery and the Society of Thoracic Surgeons joint agreement and standardized definition (Fernandez et al., 2015).
Following hospital discharge, patients will be referred for outpatient physiotherapy and nursing care. Three weeks post-discharge, patients will have a medical appointment at the Cardiothoracic Department and scheduled for the post-discharge assessment. At this appointment, patients will receive an accelerometer to wear for one week, after which a follow-up assessment will be conducted. At the end of data collection, a cost effective analysis will be perfumed aiming to achieve the real economic cost-benefit of each protocol.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Adult patients accepted for lung resection surgery, due to lung cancer, at the Cardiothoracic Department of Unidade Local de Saúde São João
- Not included in any type of prehabilitation program
- Diagnosis of cardiac, or hematological or neurologic diseases
- Pulmonary hypertension
- Renal failure
- Patients that underwent previous thoracic surgery
- Patients submitted to pneumectomy
- Patients with cognitive and mental disorders
- Patients with impairments in autonomous deambulation
- Patients already included in any prehabilitation program
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Occurrence of postoperative pulmonary complications from surgery to 30 days after discharge From the surgical procedure until 30 days after hospital discharge PPC according to the European Society of Thoracic Surgery and the Society of Thoracic Surgeons (Fernandez et al., 2015):
* Persistent air leak \> 5 days (thoracic drainage system Thopaz+ Medela)
* Atelectasis needing bronchoscopy
* Pneumonia
* Adult respiratory distress syndrome
* Bronchopleural fistula confirmed by CT scan or bronchoscopy
* Pulmonary embolism confirmed by CT scan
* Initial ventilator support \> 48 hours
* Reintubation
* Tracheostomy
* Empyema confirmed by CT scan
* Chylothorax confirmed by CT scan and pleural liquid analysisLength of hospital stay From the surgical procedure until 30 days after hospital discharge The number of days of postoperative hospitalization including hospital readmissions related to surgery, assessed in clinical data. This will be based on the patients´ clinical files.
- Secondary Outcome Measures
Name Time Method Changes in pulmonary function from baseline at the day before surgery and for 1 week 30 days after hospital discharge Baseline, day before surgery and 30 days after hospital discharge Absolute and relative values of Forced vital capacity (L) and (%); Forced Expiratory Volume in 1 second (L) and (%); Peak Expiratory Flow (L/s) and (%); Tiffeneau Index (%); Total Lung Capacity (L) and (%); Diffusion Lung Capacity for Carbon Monoxide (mmol/min/kPa) and (%); Diffusion Lung Capacity for Carbon Monoxide per unit alveolar volume (mmol/min/kPa/L) and (%) (MILLER et al., 2005). These informations will be captured using the equipment Quark PFT®, Cosmed (Rome, Italy)
Changes in respiratory muscle function from baseline at the day before surgery and for 1 week 30 days after hospital discharge Baseline, day before surgery and 30 days after hospital discharge Absolute and relative values of Maximal Voluntary Ventilation (L/min) and (%); Maximal Inspiratory Pressure (cmH2O) and (%); Maximal Expiratory Pressure (cmH2O) and (%) ("ATS/ERS Statement on respiratory muscle testing," 2002).
These informations will be captured using the equipment Quark PFT®, Cosmed (Rome, Italy)
Baseline, day before surgery and 30 days after hospital dischargeChanges in aerobic endurance from baseline, at the day before surgery and 30 days after hospital discharge Baseline, day before surgery and 30 days after hospital discharge Aerobic endurance will be assessed by the six-minute walk test (6-MWT), according to the American Thoracic Society (ATS) guidelines ("ATS statement: guidelines for the six-minute walk test," 2002). Distance (in meters), maximum and minimum oxygen saturation (%) and maximum and minimum heart rate (bpm) will be recorded. Both oxygen saturation and heart rates will be collected using the Spirodoc® (Rome, Italy).
Changes in lower body strength from baseline, at the day before surgery and 30 days after hospital discharge Baseline, day before surgery and 30 days after hospital discharge To measure lower body strength, participants will be required to perform the sit-to-stand test of the Senior Fitness Test (JONES, RIKLI \& BEAM, 1999). Patients will be instructed to sit and stand the maximum times for 30 seconds. The total number of repetitions will be recorded.
Changes on handgrip strength from baseline, at the day before surgery and 30 days after hospital discharge Baseline, day before surgery and 30 days after hospital discharge Handgrip strength will be assessed using the dynamometer Jamar Plus + Digital hand dynamometer (Sammons Preston Inc., Bolingbrook, Illinois, USA). Measurements will be carried out according to the American Society of Hand Therapists Recommendations (MacDermid et al., 2015). In brief, three measurements will be assessed in both arms, with 1 minute interval between attempts. The highest record for each arm will be used as the result.
Changes in balance from baseline, at the day before surgery and 30 days after hospital discharge Baseline, day before surgery and 30 days after hospital discharge Balance will be measured by the balance test of the Short Physical Performance Battery. In brief, participants must stand for the maximum of 10 seconds with the two feet side by side, holding semitandem, or holding tandem (GURALNIK et al., 1994).
Changes in speed walk from baseline, at the day before surgery and 30 days after hospital discharge Baseline, day before surgery and 30 days after hospital discharge. Speed walk will be measured according to the Short Physical Performance Battery. To measure speed walk, participants must walk along 4 meters using their usual speed. Procedure will be performed 3 times (GURALNIK et al., 1994).
Changes in lower body power from baseline, at the day before surgery and 30 days after hospital discharge Baseline, day before surgery and 30 days after hospital discharge. Lower body power will be measured according to the Short Physical Performance Battery. Participants will be asked to stand up and sit down from an armless chair 5 times as fast as possible, and the time spend in the task will be record, and to (GURALNIK et al., 2000).
Changes in agility, coordination and dynamic balance from baseline, at the day before surgery and 30 days after hospital discharge Baseline, day before surgery and 30 days after hospital discharge. Agility, coordination and dynamic balance will be measured by the time up and go test presented in the Vivifrail battery (IZQUIERDO et al., 2016). The test will start with the participant sitting in a chair. At the evaluated sign, the participants will stand up, walk 3 meters, and turn back to the chair. The time to accomplish this task will be recorded.
Changes in dyspnea from baseline, at the day before surgery and 30 days after hospital discharge Baseline, day before surgery and 30 days after hospital discharge The modified Medical Research Council Dyspnea Questionnaire will be used to observed dyspnea. The questionary contains 5 sentences about daily activities that might promote dyspnea, and the participants will classify their self-perception of dyspnea according to a score ranging from 0 to 4 points (RIBEIRO et al., 2022).
Changes in fatigue from baseline, the day before surgery and 30 days after hospital discharge Baseline, day before surgery and 30 days after hospital discharge Fatigue will be determined through the Fatigue Assessment Scale, which is composed by 10 questions related to physical and mental fatigue, with a Lickert scale (1 to 5). The total score ranges from 10 to 50, which higher results indicating a more severe fatigue profile (MICHIELSEN et al., 2004).
Changes in anxiety and depression from baseline, the day before surgery and 30 days after hospital discharge Baseline, day before surgery and 30 days after hospital discharge Anxiety and depression will be evaluated with The Hospital Anxiety and Depression Scale. This scale consists of two subscales, one for anxiety and the other for depression. Higher results will indicate a potential presence of anxiety and depression (PAIS-RIBEIRO et al., 2007).
Changes in quality of life from baseline, the day before surgery and 30 days after hospital discharge Baseline, day before surgery and 30 days after hospital discharge Health-related quality of life will be observed with the EuroQol 5D-5L. This questionnaire contains the dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and participants also classified their perception of general health status (FENG et al., 2021).
Changes in objectively daily physical activity from baseline at the day before surgery and for 1 week 30 days after hospital discharge From baseline to the day before surgery and for 1 week 30 days after hospital discharge Daily physical activity data will be objectively collected using GT3X+ accelerometers (ActiGraph®, LLC, Pensacola, FL, USA). The devices will be wearing for 8 hours during the waiting time for surgery and during 7 days after 30 days of hospital discharge. Data will be processed using the ActiLife software (ActiLife®, LLC, Pensacola, FL, USA).
Changes in subjective daily physical activity from baseline, at the day before surgery and 30 days after hospital discharge Baseline, day before surgery and 30 days after hospital discharge The Physical Activity Questionnaire - Short Form (IPAQ-SF) will be used to report subjective daily physical activity. Questions covering information about the weekly volume spent at vigorous, moderate and light physical activity, and the amount of time spending in the sitting position will be collected during the waiting time for surgery and during 7 days after 30 days of hospital discharge (CRAIG et al., 2003).
Change from Baseline on body composition at the day before surgery and 30 days after hospital discharge Baseline, day before surgery and 30 days after hospital discharge Body composition variables (body mass (kg), fat-free mass (kg) and fat mass (kg)) will be analyzed with a bioimpedance (InBody 770®, InBody Co. Ltd., Seoul, South Korea).
Changes in body mass index from baseline at the day before surgery and 30 days after hospital discharge Baseline, day before surgery and 30 days after hospital discharge Body mass index will be calculated by the formula: weight divided by squared height. Weight will be assessed with the scale InBody 770 ®, InBody Co. Ltd., Seoul, South Korea) and height with a wall mounted stadiometer.
Changes in food intake from baseline at the day before surgery and 30 days after hospital discharge Baseline, day before surgery and 30 days after hospital discharge Registration of food intake, including alcohol consumption, will be determined with the 1-day food record. Data will be analyzed using the Food Processor Software®.
Changes in tabaco smoking habits from baseline at the day before surgery and 30 days after hospital discharge Baseline, day before surgery and 30 days after hospital discharge Registration of smoking habits as "never smoker", "former smoker" or "smoker". For the "former smoker" and "smoker", it will be calculated the tabaco consumption by the number of pack year unity using the formula: number of cigarettes per day / 20 X number of smoking years (BERNAARDS et al., 2001).
Economic impact Surgical procedure until 30 days after hospital discharge Specific costs attributed to each intervention and comparison cost-effectiveness of each program.
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Trial Locations
- Locations (1)
Faculty of Sport - University of Porto
🇵🇹Porto, Portugal