Short-term Effects of Preoperative Exercise in Moderate-to-high Perioperative Risk Lung Cancer Patients
- Conditions
- Lung Cancer
- Interventions
- Behavioral: high-intensity interval trainingBehavioral: moderate-intensity continuous training
- Registration Number
- NCT06215326
- Lead Sponsor
- Guangdong Provincial People's Hospital
- Brief Summary
The goal of this clinical trail is to compare the effects of preoperative exercise training of different intensities on short-term cardiorespiratory function and postoperative outcomes in patients scheduled for lung resections.
- Detailed Description
Guangdong Provincial People's Hospital will be the lead center, with an additional 3 hospitals designated as satellite centers for the study. To sum up, these centers will recruit a total of 100 consenting patients. Following informed consent and baseline testing, participants will be randomized into one of the three groups in a 2:1:1 ratio: MICT, HIIT, or usual care (UC).
Participants in the MICT and HIIT groups perform a total of 12 sessions of supervised exercise training, while participants randomized to the UC group receive no extra rehabilitation or physical activity. All participants are followed-up at the completion of the intervention period.Primary outcomes including cardiopulmonary exercise function and pulmonary function will be measured at diagnosis (lung cancer patients scheduled for surgical treatment) (V1), baseline (V2), and post-intervention (V3). The baseline assessment includes medical history and examination. To lessen the psychological burden of the study on the patients, the baseline examination phase could not be repeated if the examinations had been completed during the screening phase and the date of completion was within 7 days prior to enrollment. The patient's postoperative complications, chest tube removal time and hospital length of stay (LOS) will be recorded on the day of discharge (V4). Patient-reported outcomes (PROs) will be measured at baseline (V2), post-intervention (V3), day of discharge (V4), 1 month postoperative (V5), and 3 months postoperative (V6) with ongoing follow-up. Participant blood samples and diaphragm ultrasound will be retained at baseline(V2) and post-intervention (V3) as available. Postoperative deaths will be followed up by telephone on the day of discharge (V4), 3 months postoperatively (V6), 1 year postoperatively (V7), 3 years postoperatively (V8), and 5 years postoperatively (V9).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Age>18 years.
- Suspected or confirmed primary lung cancer with scheduled surgical treatment.
- Moderate-to-high perioperative risk, defined as FEV1<60% of predicted value (wedge) or ppo FEV1<60% of predicted value (lobectomy/segmentectomy) or VO2peak<20 ml/kg/ min.
- Sign informed consent and accept to comply with the requirements of the study protocol.
- Completion of a baseline Complete cardiopulmonary exercise testing (CPET).
- Concurrent or previous history of other malignant tumors.
- Life expectancy less than 1 year.
- Dementia; infirmity; or inability to participate in sports (musculoskeletal limitations, namely, injuries, frailty, and weakness).
- Inability to maintain exercise training.
- Irregular vital signs (heart rate: < 40 or > 120 bpm at rest; blood pressure: systolic blood pressure > 200 mm Hg or diastolic pressure > 110 mm Hg; T: ≥ 38.5 or ≤ 36◦C; SpO2 ≤ 90%).
- Currently enrolling in any other clinical trials.
- Patient refusal.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High-intensity Interval Training (HIIT) Group high-intensity interval training HIIT plan is containing usual care protocol and additional complete a total of 12 supervised high-intensity interval training training sessions in 2-3 weeks. Moderate-intensity Continuous Training (MICT) Group moderate-intensity continuous training MICT plan is containing usual care protocol and additional complete a total of 12 supervised moderate-intensity continuous training sessions in 2-3 weeks.
- Primary Outcome Measures
Name Time Method cardiopulmonary fitness baseline，2 weeks The post-training change in cardiorespiratory fitness will be measured by the VO2peak in ml/kg/min.VO2peak will be evaluated by a cardiopulmonary exercise test.
pulmonary function baseline，2 weeks Pulmonary function will be measured as the first step of the CPET. Predicted postoperative (PPO) lung functions will be calculated by the Forced Expiratory Volume in one second (FEV1). Pulmonary function in patients scheduled for wedge resection will be assessed as a predicted percentage of FEV1. Whereas participants planning to have segmentectomy or lobectomy will be evaluated with PPO FEV1 as a percentage of predicted value.
- Secondary Outcome Measures
Name Time Method postoperative complications 1 week postoperative Postoperative complications will be recorded and graded specifically according to a modified version of the Thoracic Mortality and Morbidity (TMM) classification system, and related treatments will be recorded, with statistics on the incidence of TMM grade 2 or higher complications. In addition, chest tube duration and hospital LOS will be recorded.
postoperative mortality 3 months, 1 year, 3 years and 5 years postoperative Postoperative mortality will be recorded by calling.
patient-reported outcomes baseline，2 weeks, 1 week postoperative, 1 month postoperative and 3 months postoperative The MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC), a validated lung cancer-specific scale, will be utilized to assesses patients' symptoms to measure patient-reported outcomes(PROs).MDASI-LC includes 16 symptom items with scores ranging from 0 (no symptom) to 10 (worst symptom imaginable) and six functional items with scores ranging from 0 (no interference) to 10 (complete interference).
Trial Locations
- Locations (1)
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, Guangdong, China