Effects of preoperative exercise on lung cancer patients

Short-term Effects of Preoperative Exercise in Moderate-to-high Perioperative Risk Lung Cancer Patients(PRE-EXELUCA): a Multicenter Prospective Randomized Controlled Clinical Trial

This study is testing whether different levels of exercise before surgery can help lung cancer patients breathe better and recover more quickly after their operation.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Guangdong Provincial People's Hospital (other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06215326 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the impact of different intensities of preoperative exercise training on cardiorespiratory function and postoperative outcomes in lung cancer patients at moderate-to-high perioperative risk. Participants will be randomized into three groups: moderate-intensity continuous training (MICT), high-intensity interval training (HIIT), or usual care (UC). The study will involve 12 sessions of supervised exercise for the MICT and HIIT groups, while the UC group will not receive additional rehabilitation. Outcomes will be assessed through various measures, including cardiopulmonary exercise function and patient-reported outcomes, at multiple time points throughout the study.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with suspected or confirmed primary lung cancer and moderate-to-high perioperative risk.

Not a fit: Patients with concurrent malignancies, severe comorbidities, or those unable to participate in exercise training may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve postoperative recovery and overall outcomes for lung cancer patients undergoing surgery.

How similar studies have performed: Previous studies have shown positive outcomes with preoperative exercise interventions in surgical patients, suggesting potential for success in this approach.

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.

Where this trial is running

Guangzhou, Guangdong

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Huan Ma, PhD

Conditions: Lung Cancer, preoperative exercise, moderate-to-high perioperative risk, cardiorespiratory function, postoperative outcomes