AzTrials
AzTrials

Lung CancerPRE-EXELUCANCT06215326

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

A study testing moderate-intensity continuous training and high-intensity interval training in people with Lung Cancer, run by Guangdong Provincial People's Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer
What is being tested?
moderate-intensity continuous training and high-intensity interval training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
23 Jan 2024to 31 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

    Huan Ma, +8615078755932, mahuandoctor@163.com

    Recruiting

Other trials in China

About this study

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

Read the detailed description

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.

Conditions
Lung Cancer
Being tested
moderate-intensity continuous training, high-intensity interval training
Keywords
Lung Cancer, preoperative exercise, moderate-to-high perioperative risk, cardiorespiratory function, postoperative outcomes
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • moderate-intensity continuous trainingBehavioural

    Also called MICT

    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 trainingBehavioural

    Also called HIIT

    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.

Study groups in NCT06215326
Study groupRoleWhat they receive
Moderate-intensity Continuous Training (MICT) GroupExperimentalMICT plan is containing usual care protocol and additional complete a total of 12 supervised moderate-intensity continuous training sessions in 2 weeks.
Receives: Behavioral: moderate-intensity continuous training
High-intensity Interval Training (HIIT) GroupExperimentalHIIT plan is containing usual care protocol and additional complete a total of 12 supervised high-intensity interval training training sessions in 2 weeks.
Receives: Behavioral: high-intensity interval training
Usual care groupNo interventionUsual care includes standard preoperative assessments and receive routine preoperative health education according to institutional practice

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline,2 weeks

Secondary outcomes (4)
  1. pulmonary function

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

    Measured: 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.

    Measured: postoperative hospital stay, 1 month after surgery

  3. postoperative mortality

    Postoperative mortality will be recorded by calling.

    Measured: 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).

    Measured: baseline,2 weeks, 1 week postoperative, 1 month postoperative and 3 months postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2024
  2. Study start23 Jan 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06215326
Sponsor's protocol ID
KY2023-535
Acronym
PRE-EXELUCA
Status last verified
Jul 2026
First submitted
20 Dec 2023
Last updated
3 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Drevet G, Belaroussi Y, Duruisseaux M, Chalabreysse L, Grima R, Maury JM, Tronc F. Futile lobectomies following video-thoracoscopic exploration for indeterminate pulmonary nodules: a retrospective study. J Thorac Dis. 2022 Aug;14(8):2826-2834. doi: 10.21037/jtd-21-1789.

    PubMed 36071782
  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338
  • Xia C, Dong X, Li H, Cao M, Sun D, He S, Yang F, Yan X, Zhang S, Li N, Chen W. Cancer statistics in China and United States, 2022: profiles, trends, and determinants. Chin Med J (Engl). 2022 Feb 9;135(5):584-590. doi: 10.1097/CM9.0000000000002108.

    PubMed 35143424
  • Howington JA, Blum MG, Chang AC, Balekian AA, Murthy SC. Treatment of stage I and II non-small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e278S-e313S. doi: 10.1378/chest.12-2359.

    PubMed 23649443
  • Brunelli A, Refai MA, Salati M, Sabbatini A, Morgan-Hughes NJ, Rocco G. Carbon monoxide lung diffusion capacity improves risk stratification in patients without airflow limitation: evidence for systematic measurement before lung resection. Eur J Cardiothorac Surg. 2006 Apr;29(4):567-70. doi: 10.1016/j.ejcts.2006.01.014. Epub 2006 Feb 14.

    PubMed 16481190
  • Brunelli A, Charloux A, Bolliger CT, Rocco G, Sculier JP, Varela G, Licker M, Ferguson MK, Faivre-Finn C, Huber RM, Clini EM, Win T, De Ruysscher D, Goldman L; European Respiratory Society and European Society of Thoracic Surgeons joint task force on fitness for radical therapy. ERS/ESTS clinical guidelines on fitness for radical therapy in lung cancer patients (surgery and chemo-radiotherapy). Eur Respir J. 2009 Jul;34(1):17-41. doi: 10.1183/09031936.00184308.

    PubMed 19567600
  • Berry MF, Villamizar-Ortiz NR, Tong BC, Burfeind WR Jr, Harpole DH, D'Amico TA, Onaitis MW. Pulmonary function tests do not predict pulmonary complications after thoracoscopic lobectomy. Ann Thorac Surg. 2010 Apr;89(4):1044-51; discussion 1051-2. doi: 10.1016/j.athoracsur.2009.12.065.

    PubMed 20338305
  • 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.

    PubMed 20847073
  • Brunelli A, Kim AW, Berger KI, Addrizzo-Harris DJ. Physiologic evaluation of the patient with lung cancer being considered for resectional surgery: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e166S-e190S. doi: 10.1378/chest.12-2395.

    PubMed 23649437
  • Odor PM, Bampoe S, Gilhooly D, Creagh-Brown B, Moonesinghe SR. Perioperative interventions for prevention of postoperative pulmonary complications: systematic review and meta-analysis. BMJ. 2020 Mar 11;368:m540. doi: 10.1136/bmj.m540.

    PubMed 32161042
  • Liu Z, Qiu T, Pei L, Zhang Y, Xu L, Cui Y, Liang N, Li S, Chen W, Huang Y. Two-Week Multimodal Prehabilitation Program Improves Perioperative Functional Capability in Patients Undergoing Thoracoscopic Lobectomy for Lung Cancer: A Randomized Controlled Trial. Anesth Analg. 2020 Sep;131(3):840-849. doi: 10.1213/ANE.0000000000004342.

    PubMed 31348053
  • Licker M, Karenovics W, Diaper J, Fresard I, Triponez F, Ellenberger C, Schorer R, Kayser B, Bridevaux PO. Short-Term Preoperative High-Intensity Interval Training in Patients Awaiting Lung Cancer Surgery: A Randomized Controlled Trial. J Thorac Oncol. 2017 Feb;12(2):323-333. doi: 10.1016/j.jtho.2016.09.125. Epub 2016 Oct 19.

    PubMed 27771425
  • Steffens D, Beckenkamp PR, Hancock M, Solomon M, Young J. Preoperative exercise halves the postoperative complication rate in patients with lung cancer: a systematic review of the effect of exercise on complications, length of stay and quality of life in patients with cancer. Br J Sports Med. 2018 Mar;52(5):344. doi: 10.1136/bjsports-2017-098032. Epub 2018 Feb 1.

    PubMed 29437041
  • Gravier FE, Smondack P, Prieur G, Medrinal C, Combret Y, Muir JF, Baste JM, Cuvelier A, Boujibar F, Bonnevie T. Effects of exercise training in people with non-small cell lung cancer before lung resection: a systematic review and meta-analysis. Thorax. 2022 May;77(5):486-496. doi: 10.1136/thoraxjnl-2021-217242. Epub 2021 Aug 24.

    PubMed 34429375
  • Granger C, Cavalheri V. Preoperative exercise training for people with non-small cell lung cancer. Cochrane Database Syst Rev. 2022 Sep 28;9(9):CD012020. doi: 10.1002/14651858.CD012020.pub3.

    PubMed 36170564

Questions about this trial

What is this clinical trial studying?

A study testing moderate-intensity continuous training and high-intensity interval training in people with Lung Cancer, run by Guangdong Provincial People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Huan Ma, PhD (+86 15078755932, mahuandoctor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

cardiopulmonary fitness (time frame: baseline,2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06215326, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in