Clinical trial NCT06432634: Effects of CPRP on Patients Undergoing Lung Resection
Official title: Effects of Comprehensive Pulmonary Rehabilitation Programs (CPRP) on Patients Undergoing Lung Resection: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rehabilitation
Keywords: lung resection surgery
comprehensive pulmonary rehabilitation programs
six-minute walk test
quality of life
biomarkers
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-05-29
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Six-minute walk distance (6MWD)
timeFrame: Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks
Secondary outcomes:
measure: Pulmonary function test
timeFrame: Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks
measure: Respiratory muscle strength
timeFrame: Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks
measure: Length of hospital stay (LoS)
timeFrame: an average of post-surgery 2 weeks
measure: Duration of chest-tube insertion
timeFrame: an average of post-surgery 2 weeks
measure: Numerical Rating Scale (NRS)
timeFrame: Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks
measure: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30, version 3, Chinese Mandarin (Taiwan))
timeFrame: Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks
measure: Postoperative complications (POCs) and postoperative pulmonary complications (PPCs)
timeFrame: an average of post-surgery 2 weeks
measure: Lung expansion volume
timeFrame: Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks
Other outcomes:
measure: inflammation-related and immune-related biomarkers
timeFrame: Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks
Locations:
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chun-Jung Chang
role: PRINCIPAL_INVESTIGATOR
References: