Prehabilitation for Lung Cancer Patients Undergoing Lung Resection

NCT ID: NCT06802627

Last Updated: 2025-01-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-01
• Study Completion Date: 2027-11-30

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.

Conditions

Lung Cancer; Lung Resection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Control Group (CG)

Control group will receive a single in-person preoperative education session at the Faculty of Sport of University of Porto, one week after the patient's inclusion in the study. The education session will be delivered for the patient and his/her caregiver or family member.

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.

Group Type: ACTIVE_COMPARATOR

Education session

Intervention Type: OTHER

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 (IMT-G)

The IMT-G will be submitted to an education session (equal to the CG) plus 2-weeks of 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. All sessions will start with 5 min of stretching exercises and then the IMT. 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 All IMT session will take place at São João Hospital.

Group Type: EXPERIMENTAL

Education session

Intervention Type: OTHER

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

Intervention Type: OTHER

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 (EMT-G)

The EMT-G will be submitted to an education session (equal to the CG) plus 2-weeks of 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:

• 5 minutes of stretching exercises
• 8 minutes of abdominal resistance exercises (1st week: 2 exercises, 4 sets of 8 repetitions; 2nd 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. All EMT session will take place at São João Hospital.

Group Type: EXPERIMENTAL

Education session

Intervention Type: OTHER

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.

Expiratory muscle training group

Intervention Type: OTHER

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 (GET-G)

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.

Group Type: EXPERIMENTAL

Education session

Intervention Type: OTHER

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.

Global exercise training group

Intervention Type: OTHER

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.

Interventions

Education session

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.

Intervention Type: OTHER

Inspiratory muscle training group

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

Intervention Type: OTHER

Expiratory muscle training group

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.

Intervention Type: OTHER

Global exercise training group

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centro Hospitalar De São João, E.P.E.

OTHER

Sponsor Role: collaborator

Universidade do Porto

OTHER

Sponsor Role: lead

Responsible Party

Filipa Kendall

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

José F Oliveira, PhD

Role: STUDY_CHAIR

Faculty of Sport - University of Porto

Locations

Faculty of Sport - University of Porto

Porto, Porto District, Portugal

Countries

Portugal

Central Contacts

Filipa C Kendall, PhD

Role: CONTACT

fckendall@fade.up.pt

00351919840750

Lucimére Bonh, PhD

Role: CONTACT

licimerebohn@fade.up.pt

00351917028600

Facility Contacts

Filipa Kendall, Phd

Role: primary

fckendall@fade.up.pt

+351919840750

Lucimére Bonh, PhD

Role: backup

lucimerebonh@fade.up.pt

+351917028600

José F Oliveira, PhD

Role: backup

Débora G Silva, Masters

Role: backup

Luísa Gonçalves, PhD

Role: backup

Pedro Fernandes, MD

Role: backup

Ana Godinho, FT

Role: backup

Cristina Teixeira, Masters

Role: backup

Gabriela Fernandes, PhD

Role: backup

Ermelinda Eusébio

Role: backup

Lucimére Bohn, Phd

Role: backup

Filipa Kendall, Phd

Role: backup

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Other Identifiers

Ethics Committee CHUSJ 52/2024

Identifier Type: -

Identifier Source: org_study_id