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NCT Number: NCT06215326

Short-term Effects of Preoperative Exercise in Moderate-to-high Perioperative Risk Lung Cancer Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location status: Recruiting

Location contact

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

Moderate-Intensity Continuous Training

Behavioral

Participants in MICT group will need to additional complete a total of 12 supervised training sessions in 2-3 weeks.After a warm-up of 5 minutes at 50% at peak WR, the patient start exercising at 60%-70% peak WR for 30-40 minutes (four 5-8 minutes sets, with a 2-min rest in between), and then the patients cooled down for 5 minutes at 50% peak WR. Moderate-intensity exercise training intensity control at 55-74% HRmax or 40-69% VO2peak or PRE12-13 as recommended by guidelines.

Other names: MICT

High-intensity interval training

Behavioral

Participants in HIIT group will need to additional complete a total of 12 supervised training sessions in 2-3 weeks.After a 5-minute warm-up at 50% at peak WR, the patients complete 20 series of vigorous-intensity sprint (80%-100% peak WR for 30-60s) separated by a low-intensity recovery (30% peak WR or completely rest for 15s), and then the patients cooled down for 5 minutes at 50% peak WR. Participants will begin training at a relatively moderate intensity (60%-65% peak WR) for the first 3 sessions and gradually increase to the target intensity beginning on the 4th session. Intensity control of high-intensity exercise training at 75-90% HRmax or 70-85% VO2peak or PRE14-16 as recommended by guidelines.

Other names: HIIT

Primary outcomes

  1. cardiopulmonary fitness

    Time frame: 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.

  2. pulmonary function

    Time frame: 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 outcomes

  1. postoperative complications

    Time frame: 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.

  2. postoperative mortality

    Time frame: 3 months, 1 year, 3 years and 5 years postoperative

    Postoperative mortality will be recorded by calling.

  3. patient-reported outcomes

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Huan Ma, PhD

CONTACT

[email protected]

+86 15078755932

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Official study 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

Acronym: PRE-EXELUCA

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 22, 2024
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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