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

ConditionLung Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangdong Provincial People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • moderate-intensity continuous training

    Behavioral

    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.

  • high-intensity interval training

    Behavioral

    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.

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Moderate-intensity Continuous Training (MICT) GroupExperimental treatment 1 intervention
Group B: High-intensity Interval Training (HIIT) GroupExperimental treatment 1 intervention
Group C: Usual care groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

cardiopulmonary fitness

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.

Time frame
baseline，2 weeks

Secondary outcomes

1

pulmonary function

Pulmonary function will be measured as the guidelines recommended, including FVC, FEV1, FEV1/FVC.

Time frame
baseline，2 weeks
2

postoperative complications

Postoperative complications will be recorded and graded specifically according to the Society of Thoracic Surgeons. In addition, chest tube duration and hospital LOS will be recorded.

Time frame
postoperative hospital stay, 1 month after surgery
3

postoperative mortality

Postoperative mortality will be recorded by calling.

Time frame
3 months, 1 year, 3 years and 5 years postoperative
4

patient-reported outcomes

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).

Time frame
baseline，2 weeks, 1 week postoperative, 1 month postoperative and 3 months postoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Provincial People's Hospital

Lead sponsor

Source ClinicalTrials.gov
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