Effects of CPRP on Patients Undergoing Lung Resection
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard care, Comprehensive pulmonary rehabilitation programs.
- Who it may be relevant to
- Registry conditions: Rehabilitation. Basic parameters: from 20 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Taiwan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Comprehensive Pulmonary Rehabilitation Programs (CPRP) on Patients Undergoing Lung Resection: a Randomized Controlled Trial
Overview
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.
Interventions
- Other 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) adminis - 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
Primary outcome measures
- Six-minute walk distance (6MWD) [Time frame: Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks]
Secondary outcome measures (8)
- Pulmonary function test [Time frame: Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks]
- Respiratory muscle strength [Time frame: Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks]
- Length of hospital stay (LoS) [Time frame: an average of post-surgery 2 weeks]
- Duration of chest-tube insertion [Time frame: an average of post-surgery 2 weeks]
- Numerical Rating Scale (NRS) [Time frame: Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks]
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30, version 3, Chinese Mandarin (Taiwan)) [Time frame: Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks]
- Postoperative complications (POCs) and postoperative pulmonary complications (PPCs) [Time frame: an average of post-surgery 2 weeks]
- Lung expansion volume [Time frame: Baseline; one day pre-surgery; an average of post-surgery 2 weeks; through study completion, an average of 10 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Taiwan · 1 center
- Chang Gung Memorial Hospital — Chiayi City
Identifiers
NCT: NCT06432634 · 202400512B0