Clinical trial NCT06215326: Short-term Effects of Preoperative Exercise in Moderate-to-high Perioperative Risk Lung Cancer Patients
Official title: Short-term Effects of Preoperative Exercise in Moderate-to-high Perioperative Risk Lung Cancer Patients(PRE-EXELUCA): a Multicenter Prospective Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: Lung Cancer
preoperative exercise
moderate-to-high perioperative risk
cardiorespiratory function
postoperative outcomes
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2024-01-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

1. Age\>18 years.
2. Suspected or confirmed primary lung cancer with scheduled surgical treatment.
3. 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.
4. Sign informed consent and accept to comply with the requirements of the study protocol.
5. Completion of a baseline Complete cardiopulmonary exercise testing (CPET).

Exclusion Criteria:

1. Concurrent or previous history of other malignant tumors.
2. Life expectancy less than 1 year.
3. Dementia; infirmity; or inability to participate in sports (musculoskeletal limitations, namely, injuries, frailty, and weakness).
4. Inability to maintain exercise training.
5. 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%).
6. Currently enrolling in any other clinical trials.
7. Patient refusal.

Primary outcomes:
measure: cardiopulmonary fitness
timeFrame: baseline，2 weeks
measure: pulmonary function
timeFrame: baseline，2 weeks
Secondary outcomes:
measure: postoperative complications
timeFrame: 1 week postoperative
measure: postoperative mortality
timeFrame: 3 months, 1 year, 3 years and 5 years postoperative
measure: patient-reported outcomes
timeFrame: baseline，2 weeks, 1 week postoperative, 1 month postoperative and 3 months postoperative
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
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