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

February 28, 2024 updated by: Guangdong Provincial People's Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Moderate-intensity Continuous Training (MICT) Group
MICT plan is containing usual care protocol and additional complete a total of 12 supervised moderate-intensity continuous training sessions in 2-3 weeks.
Behavioral: moderate-intensity continuous training
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
Experimental: High-intensity Interval Training (HIIT) Group
HIIT plan is containing usual care protocol and additional complete a total of 12 supervised high-intensity interval training training sessions in 2-3 weeks.
Behavioral: high-intensity interval training
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
No Intervention: Usual care group
Usual care is including smoking cessation instruction, respiratory exercise, review by a specialist nurse, meeting with the surgeon and anesthetist, and receiving information about preparing for surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline，2 weeks
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.
baseline，2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week postoperative
postoperative mortality
Time Frame: 3 months, 1 year, 3 years and 5 years postoperative
Postoperative mortality will be recorded by calling.
3 months, 1 year, 3 years and 5 years postoperative
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).
baseline，2 weeks, 1 week postoperative, 1 month postoperative and 3 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 20, 2023

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2023-535

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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