Prehabilitation for Lung Cancer Patients Undergoing Lung Resection

NCT06802627 | Not Yet Recruiting DMC

• 1 other identifier: Ethics Committee CHUSJ 52/2024
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Lung Resection

Keywords

Prehabilitation; Lung resection; Exercise training; Postoperative pulmonary complications; Respiratory muscle training; Education

Outcome Measures

Primary Outcomes (2)

• 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

  From the surgical procedure until 30 days after hospital discharge

• 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.

  From the surgical procedure until 30 days after hospital discharge

Secondary Outcomes (20)

• 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

• 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

• Changes 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

• 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

• 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

Other Outcomes (3)

• Sociodemographic variables

  Baseline

• Medical history

  Baseline

• Barriers questionnaire for prehabilitation

  Baseline

Study Arms (4)

Control Group (CG)

ACTIVE COMPARATOR

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.

Other: Education session

Inspiratory Muscle Training Group (IMT-G)

EXPERIMENTAL

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.

Other: Education session; Other: Inspiratory muscle training group

Expiratory Muscle Training Group (EMT-G)

EXPERIMENTAL

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.

Other: Education session; Other: Expiratory muscle training group

Global Exercise Training Group (GET-G)

EXPERIMENTAL

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.

Other: Education session; Other: Global exercise training group

Interventions

Education session 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.

Control Group (CG); Expiratory Muscle Training Group (EMT-G); Global Exercise Training Group (GET-G); Inspiratory Muscle Training Group (IMT-G)

Inspiratory muscle training group 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

Inspiratory Muscle Training Group (IMT-G)

Expiratory muscle training group 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.

Expiratory Muscle Training Group (EMT-G)

Global exercise training group 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.

Global Exercise Training Group (GET-G)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade do Porto: lead
• Centro Hospitalar De São João, E.P.E.: collaborator

Study Sites (1)

Faculty of Sport - University of Porto

Porto, Porto District, 4200-450, Portugal

Location

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MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• José F Oliveira, PhD

  Faculty of Sport - University of Porto

  STUDY CHAIR

Central Study Contacts

Filipa C Kendall, PhD

CONTACT

00351919840750; fckendall@fade.up.pt

Lucimére Bonh, PhD

CONTACT

00351917028600; licimerebohn@fade.up.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Model Details: Patients will be randomized at baseline into one of the four intervention - Control group (CG) receive an education session; inspiratory muscle training group (IMT-G) receive an education session plus inspiratory muscle training; expiratory muscle training group (EMT-G) receive an education session plus expiratory muscle training; global exercise training group (GET-G) receive an education session plus physical exercise training.

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: January 31, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)