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

NCT06215326 | Recruiting

• 1 other identifier: KY2023-535
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Keywords

Lung Cancer; preoperative exercise; moderate-to-high perioperative risk; cardiorespiratory function; postoperative outcomes

Outcome Measures

Primary Outcomes (2)

• 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.

  baseline，2 weeks

• pulmonary function

  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 Outcomes (3)

• postoperative complications

  1 week postoperative

• postoperative mortality

  3 months, 1 year, 3 years and 5 years postoperative

• patient-reported outcomes

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

Study Arms (3)

Moderate-intensity Continuous Training (MICT) Group

EXPERIMENTAL

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

High-intensity Interval Training (HIIT) Group

EXPERIMENTAL

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

Usual care group

NO INTERVENTION

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.

Interventions

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.

Also known as: MICT

Moderate-intensity Continuous Training (MICT) Group

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.

Also known as: HIIT

High-intensity Interval Training (HIIT) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Related Publications (18)

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  PMID: 20338305 RESULT

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  PMID: 20847073 RESULT

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  PMID: 23649437 RESULT

• 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.

  PMID: 32161042 RESULT

• 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.

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• 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.

  PMID: 27771425 RESULT

• 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.

  PMID: 29437041 RESULT

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  PMID: 36170564 RESULT

• Ligibel JA, Bohlke K, May AM, Clinton SK, Demark-Wahnefried W, Gilchrist SC, Irwin ML, Late M, Mansfield S, Marshall TF, Meyerhardt JA, Thomson CA, Wood WA, Alfano CM. Exercise, Diet, and Weight Management During Cancer Treatment: ASCO Guideline. J Clin Oncol. 2022 Aug 1;40(22):2491-2507. doi: 10.1200/JCO.22.00687. Epub 2022 May 16.

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• Cavalheri V, Granger CL. Exercise training as part of lung cancer therapy. Respirology. 2020 Nov;25 Suppl 2:80-87. doi: 10.1111/resp.13869. Epub 2020 Jun 1.

  PMID: 32567236 RESULT

• Mendoza TR, Wang XS, Lu C, Palos GR, Liao Z, Mobley GM, Kapoor S, Cleeland CS. Measuring the symptom burden of lung cancer: the validity and utility of the lung cancer module of the M. D. Anderson Symptom Inventory. Oncologist. 2011;16(2):217-27. doi: 10.1634/theoncologist.2010-0193. Epub 2011 Feb 1.

  PMID: 21285393 RESULT

MeSH Terms

Conditions

Lung Neoplasms

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Huan Ma, PhD

CONTACT

+86 15078755932; mahuandoctor@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the study intervention, this study was an open trial and was not blinded to the patients and study executives. Only the outcome assessors and statistical analysts of the study will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 22, 2024
• Study Start: January 23, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 1, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)