Prehabilitation for Lung Cancer Patients Undergoing Lung Resection

NCT06802627 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-01-31

No results posted yet for this study

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

Interventions

OTHER

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.

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

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.

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.

Sponsors & Collaborators

  • Centro Hospitalar De São João, E.P.E.

    collaborator OTHER
  • Universidade do Porto

    lead OTHER

Principal Investigators

  • José F Oliveira, PhD · Faculty of Sport - University of Porto

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2027-07-01
Completion
2027-11-30

Countries

  • Portugal

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06802627 on ClinicalTrials.gov