About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Diagnosis of cardiac, or hematological or neurologic diseases

Pulmonary hypertension

Renal failure

Patients that underwent previous thoracic surgery

Trial design

Design model

Parallel

Treatments tested in this trial

Education session
Other intervention
The information that will be delivery is going to be focused on: * Lifestyle changes regarding nutrition and daily physical activity. * Abstinence of the additive behaviors smoking, alcohol, and drug consumption. * Personal hygiene care and hospital routines. * Importance of postoperative physiotherapy. A booklet summarizing the information provided at the education session will be delivered for all participants.
Inspiratory muscle training group
Other intervention
Education Session (described in the control group) Inspiratory muscle training (IMT) After the education session, patients will start the IMT program that will last two weeks. The IMT will be 5 days/ week, lasting 20 minutes, using the PowerBreath KH2 device. In the first week, the intensity of the PowerBreath KH2 will be set at 50% of the maximal inspiratory pressure (with 12 breaths per minute), and it will be increasing by 10% in the second week (with 15 breaths per minute). Patients will be continuously monitored by an oximeter and modified Borg scale
Expiratory muscle training group
Other intervention
Education Session (described in the control group) Expiratory muscle training (EMT) After the education session, patients will start the EMT that will last two weeks, 5 days a week. The sessions will last 20 minutes and will be structured as follows: 4 minutes of total body stretching exercises 8 minutes of abdominal resistance exercises: 1. First week: 2 exercises, 4 sets of 8 repetitions 2. Second week: 2 exercises, 4 sets of 10 repetitions 8 minutes of specific EMT using the Philips Respironics Threshold PEP device (Load: 20 cmH2O; 10 expirations for minute) Patients will be continuously monitored by an oximeter and modified Borg scale.
Global exercise training group
Other intervention
The GET-G will be submitted to an education session (equal to the CG) plus 2-weeks of physical exercise, 3 sessions per week, 45-60 minutes. The structure is: Warm-up: 5 minutes of whole-body stretching exercises Main workout: -Aerobic: Week 1: 20 min of treadmill walking at 70% of the mean speed achieved on the 6-minute walk test and limited by 80% of the max theoretical heart rate. Week 2: 20 min of treadmill walking at 80% of the mean speed achieved on the 6-minute walk test and limited by 80% of the max theoretical heart rate. -Resistance Week 1: 8 exercises, 2 sets of 8-10 repetitions, using body weight and elastic bands. Week 2: 8 exercises, 2 sets of 10-12 repetitions, using body weight and elastic bands Coll-down: 5 min of whole-body stretching exercises, holding the point of feeling lightness discomfort for 15 seconds. Patients will be continuously monitored by an oximeter and modified Borg scale.

Treatment groups

200 Participants

are divided into 4 treatment groups

Group A: Control Group (CG)Active comparator 1 intervention

Group B: Inspiratory Muscle Training Group (IMT-G)Experimental treatment 2 interventions

Group C: Expiratory Muscle Training Group (EMT-G)Experimental treatment 2 interventions

Group D: Global Exercise Training Group (GET-G)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Occurrence of postoperative pulmonary complications from surgery to 30 days after 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 analysis

Time frame

From the surgical procedure until 30 days after hospital discharge

2

Length of hospital stay

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.

Time frame

From the surgical procedure until 30 days after hospital discharge

Secondary outcomes

1

Changes in pulmonary function from baseline at the day before surgery and for 1 week 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)

Time frame

Baseline, day before surgery and 30 days after hospital discharge

2

Changes in respiratory muscle function from baseline at the day before surgery and for 1 week 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 discharge

Time frame

Baseline, day before surgery and 30 days after hospital discharge

3

Changes in aerobic endurance from baseline, at the 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).

Time frame

Baseline, day before surgery and 30 days after hospital discharge

4

Changes in lower body strength from baseline, at the 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.

Time frame

Baseline, day before surgery and 30 days after hospital discharge

Other outcomes

1

Sociodemographic variables

Age (years), academic level (primary, secondary, bachelor, master, PhD), civil status (married, separated, widow, single, others). These will be assessed by interview.

Time frame

Baseline

2

Medical history

Diagnosed of diseases and number of medications will be assessed by one of the research members.

Time frame

Baseline

3

Barriers questionnaire for prehabilitation

Participation in a prehabilitation program might be difficult for the same patients due to many reasons, thus, to clarify barriers and in future develop solutions, all patients who fulfill inclusion criteria will be asked to answer the barriers questionnaire, even those who decline to participate in the clinical trial. The questionnaire has 21 questions with 5 possible answers and the last one in open version.

Time frame

Baseline

Prehabilitation for Lung Cancer Patients Undergoing Lung Resection

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts