Effects of CPRP on Patients Undergoing Lung Resection

NCT ID: NCT06432634

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2027-04-30

Brief Summary

The aim of this project is to investigate the effectiveness of implementing a Comprehensive Pulmonary Rehabilitation Program (CPRP) in patients undergoing lung resection surgery. The CPRP encompasses a training regimen combining aerobic exercise, resistance exercises, breathing exercises, and home activities, specifically tailored for patients with limited exercise capacity and impaired lung function. The study seeks to understand the physiological and biological effects of the CPRP in this patient population.

Detailed Description

Background: Elderly patients with compromised lung function or poor health conditions undergoing lung resection surgery face an increased risk of postoperative pulmonary complications. Pulmonary rehabilitation programs play a crucial role in enhancing recovery after surgery, having been shown to reduce postoperative pulmonary complications and enhance patients' pre- and post-operative exercise capacity, functional performance, and quality of life. However, due to the heterogeneity of interventions in pulmonary rehabilitation programs, the optimal timing, methods, or duration of exercise training for lung resection patients remain unclear. Additionally, there is a lack of comprehensive research on the changes and impacts of biomarkers in the blood of lung resection patients following intervention with pulmonary rehabilitation programs.

Objectives: This study aims to investigate the physiological and biological effects of a comprehensive pulmonary rehabilitation program in lung resection surgery patients with limited exercise capacity and impaired lung function.

Research Methods: This study adopts an open label, randomized, parallel design, intending to recruit 96 lung resection surgery participants divided into a control group receiving standard care and an experimental group receiving the comprehensive pulmonary rehabilitation programs. The intervention period spans 1-2 weeks pre-surgery, during hospitalization, and 3-6 weeks post-discharge. Participants will undergo four assessments at randomization (baseline, T0), one day pre-surgery (T1), the day of discharge post-surgery (T2), and at trial completion (T3). The primary endpoint is the six-minute walk test. Secondary endpoints include lung function, lung expansion volume, respiratory muscle strength, incidence of postoperative complications and pulmonary complications, chest tube duration, length of hospital stay, quality of life (EORTC QLQ-C30), and pain. Exploratory endpoints involve inflammation-related and immune-related biomarkers.

Expected Impact: This study will provide valuable insights into the physiological and biological effects of a comprehensive pulmonary rehabilitation programs for lung resection surgery patients. Results may contribute to improving patient outcomes and advancing academic understanding and clinical guidelines in this field.

Conditions

Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

standard care group

Participants randomize to the standard care group (SC) receive the standard care already established in Chiayi Chang Gung Memorial Hospital. Standard care comprises one therapeutic education session conducted by a respiratory therapist 1-2 weeks before surgery.

Group Type: SHAM_COMPARATOR

Standard care

Intervention Type: OTHER

The pre-operative educational session has a duration of 40 minutes and covers pre-operative education, breathing exercises (diaphragmatic breathing, deep breathing techniques and sustained maximal inflation), and airway clearance techniques (directed cough, huffing, and chest physiotherapy). Patients are instructed to perform these techniques ten times per waking hour, every day. The in-patient peri-operative session incorporates intermittent positive pressure breathing inhalation (IPPB) administered for 15 minutes twice daily. Inhalation therapy involving mucolytics and bronchodilators is administered three times per day, and early mobilization is encouraged until discharge. Upon discharge, participants are encouraged to continue practicing breathing exercises, deep breathing techniques, and maintaining an active level of activity.

comprehensive pulmonary rehabilitation program group

Participants randomize to the comprehensive pulmonary rehabilitation program group (CPRP) undergo an evidence-based and hospital-based comprehensive pulmonary rehabilitation program developed by the research group. This program is administered in addition to the standard care provided and spans across the preoperative, peri-operative, and postoperative periods, covering a total of 1-2 weeks preoperatively and 3-6 weeks postoperatively. CPRP involves warm-up and cool-down exercises, the aerobic training, and the resistance training. Additionally, participants are encouraged to continue exercising at home or in community sports facilities.

Group Type: EXPERIMENTAL

Standard care

Intervention Type: OTHER

The pre-operative educational session has a duration of 40 minutes and covers pre-operative education, breathing exercises (diaphragmatic breathing, deep breathing techniques and sustained maximal inflation), and airway clearance techniques (directed cough, huffing, and chest physiotherapy). Patients are instructed to perform these techniques ten times per waking hour, every day. The in-patient peri-operative session incorporates intermittent positive pressure breathing inhalation (IPPB) administered for 15 minutes twice daily. Inhalation therapy involving mucolytics and bronchodilators is administered three times per day, and early mobilization is encouraged until discharge. Upon discharge, participants are encouraged to continue practicing breathing exercises, deep breathing techniques, and maintaining an active level of activity.

Comprehensive pulmonary rehabilitation programs

Intervention Type: OTHER

1. Warm-up and cool-down exercises: stretching various muscle groups for a duration of 15 to 20 minutes and a slow 3-minute walk

2. Aerobic training: using a lower-limb cycle ergometer for a duration of 30 to 40 minutes. Initiated warm-up at 0 wattages for 5 minutes. Incrementally increased wattages within 5-10 minutes until reaching the 40-80% heart rate reserve or 4 to 6 of modified Borg scale for at least 20 minutes. Concludes with a 5-minute cool-down period at 10 wattages.

3. The resistance training involves both upper and lower limbs:

（1） Upper Limb Resistance Training: Shoulder lift, abduction, and horizontal abduction exercises are performed. Each exercise is repeated for three sessions comprising 10 repetitions each. A 0.5-2 kg dumbbell is utilized for resistance.

（2） Lower Limb Resistance Training: Sit-to-stand exercises are performed. Each session consists of three sets of 10 repetitions.

Interventions

Standard care

The pre-operative educational session has a duration of 40 minutes and covers pre-operative education, breathing exercises (diaphragmatic breathing, deep breathing techniques and sustained maximal inflation), and airway clearance techniques (directed cough, huffing, and chest physiotherapy). Patients are instructed to perform these techniques ten times per waking hour, every day. The in-patient peri-operative session incorporates intermittent positive pressure breathing inhalation (IPPB) administered for 15 minutes twice daily. Inhalation therapy involving mucolytics and bronchodilators is administered three times per day, and early mobilization is encouraged until discharge. Upon discharge, participants are encouraged to continue practicing breathing exercises, deep breathing techniques, and maintaining an active level of activity.

Intervention Type: OTHER

Comprehensive pulmonary rehabilitation programs

1. Warm-up and cool-down exercises: stretching various muscle groups for a duration of 15 to 20 minutes and a slow 3-minute walk

2. Aerobic training: using a lower-limb cycle ergometer for a duration of 30 to 40 minutes. Initiated warm-up at 0 wattages for 5 minutes. Incrementally increased wattages within 5-10 minutes until reaching the 40-80% heart rate reserve or 4 to 6 of modified Borg scale for at least 20 minutes. Concludes with a 5-minute cool-down period at 10 wattages.

3. The resistance training involves both upper and lower limbs:

（1） Upper Limb Resistance Training: Shoulder lift, abduction, and horizontal abduction exercises are performed. Each exercise is repeated for three sessions comprising 10 repetitions each. A 0.5-2 kg dumbbell is utilized for resistance.

（2） Lower Limb Resistance Training: Sit-to-stand exercises are performed. Each session consists of three sets of 10 repetitions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults (age ≥ 20 years old)
• Receiving lung resection surgery
• At least one of the following:

6MWD < 500 meters, oxygen saturation by pulse oximetry (SpO2) drop ≥ 4% or SpO2< 90% during 6MWT, pre-operative forced expiratory volume in 1 second (FEV1) or forced vital capacity (FVC) ≤ 80% of predicted value or FEV1/FVC ratio ≤ 0.7

• Able to walk autonomously without mobility aids
• Written informed consent

Exclusion Criteria

• Neoadjuvant therapy with chemo- or radiotherapy in the six months prior to surgery
• Received pulmonary rehabilitation programs six months prior to surgery
• Previous lung resection
• Inability to perform the exercise training
• Instability in cardiovascular disease, neurological disorders, or musculoskeletal conditions
• Have cognitive deficits with potential severe impact on compliance
• Do not provide written informed consent

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chun-Jung Chang

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Chang Gung Memorial Hospital

Chiayi City, , Taiwan

Countries

Taiwan

Other Identifiers

202400512B0

Identifier Type: -

Identifier Source: org_study_id