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

Официальное название

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

Обзор

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.

Подробное описание

Guangdong Provincial People's Hospital 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 2:2:1 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.

Вмешательства

• Поведенческое moderate-intensity continuous training
  Each MICT session consists of 30 minutes of cycling. Workload will be gradually titrated from 50% to 60% peak WR throughout training to sustain a target RPE of 12-14 on the Borg 6-20 scale.
• Поведенческое high-intensity interval training
  Each HIIT session consists of15 cycles, includes a 60-second high-intensity interval at 80-95% peak WR (target RPE 15-17) followed by a 60-second active recovery phase at 25% peak WR.

Первичные конечные точки

• cardiopulmonary fitness [Срок оценки: baseline，2 weeks]

Вторичные конечные точки (4)

• pulmonary function [Срок оценки: baseline，2 weeks]
• postoperative complications [Срок оценки: postoperative hospital stay, 1 month after surgery]
• postoperative mortality [Срок оценки: 3 months, 1 year, 3 years and 5 years postoperative]
• patient-reported outcomes [Срок оценки: baseline，2 weeks, 1 week postoperative, 1 month postoperative and 3 months postoperative]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Guangdong Provincial People's Hospital — Гуанчжоу

Публикации

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• Licker M, Schnyder JM, Frey JG, Diaper J, Cartier V, Inan C, Robert J, Bridevaux PO, Tschopp JM. Impact of aerobic exercise capacity and procedure-related factors in lung cancer surgery. Eur Respir J. 2011 May;37(5):1189-98. doi: 10.1183/09031936.00069910. Epub 2010 Sep 16. PMID 20847073

Идентификаторы

NCT: NCT06215326 · KY2023-535

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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