A Study on Cardiopulmonary Exercise Tolerance Standards for Healthy Chinese Population

NCT07108296 | Not Yet Recruiting DMC

• 1 other identifier: KFKT-2025-KY-010
• Study Type: observational
• Target: 4,620
• Locations: 1 country
• Sites: 15

Brief Summary

This project intends to conduct a large-sample, prospective, multicenter clinical cohort study in healthy populations. By utilizing a digital cardiopulmonary rehabilitation clinical data research platform, The investigators aim to achieve automated, standardized, and uniform collection, analysis, and AI modeling of large-scale cardiopulmonary exercise testing (CPET) data. The ultimate goals are: To establish reference standards for cardiopulmonary exercise capacity in the Chinese healthy population. To develop machine learning-based predictive models for key CPET variables (e.g., peak VO₂) tailored to Chinese demographics. To compare performance differences between domestically produced and imported CPET devices.

Conditions

Oxygen Consumption; Cardiorespiratory Fitness

Keywords

Peak Oxygen Uptake; VO2@AT; Cardiopulmonary Exercise Tolerance; Prediction Model; Healthy Population

Outcome Measures

Primary Outcomes (1)

• Peak Oxygen Uptake

  When measuring the peak oxygen uptake of healthy people with a cycle ergometer, first ensure participants are healthy and have signed consent forms. Prepare the cycle ergometer and other equipment, adjusting them to a suitable position. After a 3 - minute warm - up, start the incremental loading test, which lasts 8 - 12 minutes, until termination criteria are met. Record the data, calculate the peak oxygen uptake, and assess the cardiopulmonary function.

  On the day of enrollment

Study Arms (1)

Chinese Age-Sex-Stratified Cardiopulmonary Function Cohort (CACSF Cohort)

Other: cardiopulmonary exercise testing (CPET)

Interventions

cardiopulmonary exercise testing (CPET) OTHER

In this study, the cardiopulmonary exercise testing (CPET) system used breath-by-breath continuous analysis for gas exchange and ventilation variables. The protocol included spirometry with an 8-breath data collection method. The cycle ergometer workload ranged from 10 to 40 W/min using a RAMP protocol. The standard CPET protocol comprised a 3-min rest, 3-min warm-up, 8 - 12 min incremental exercise phase, and 3-min each of active and passive recovery.

Chinese Age-Sex-Stratified Cardiopulmonary Function Cohort (CACSF Cohort)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy individuals aged 18 - 65.

You may qualify if:

• Detailed medical history taken, with no symptoms of discomfort reported
• Good physical condition, with no history of severe chronic diseases
• No history of long - term medication use
• Willing to undergo cardiopulmonary exercise testing, with no ST - T segment changes observed during the test
• Age: 18 - 65 years old
• BMI: 18.5 - 28kg/m²
• No smoking history or quit smoking for ≥5 years
• Physical examination reports within 2 years show no significant abnormalities.

You may not qualify if:

• Pre - test resting blood pressure ≥160/100 mmHg (1 mmHg=0.133 kPa)
• Chronic cardiovascular diseases, such as heart failure, coronary atherosclerotic heart disease, hypertension, congenital heart disease, cardiomyopathy, and severe arrhythmias
• Respiratory diseases, such as chronic obstructive pulmonary disease, asthma, pulmonary artery hypertension, bronchiectasis, and respiratory failure
• Digestive system diseases, such as peptic ulcer, gastrointestinal bleeding, hepatitis, liver cirrhosis, ulcerative colitis, Crohn's disease, chronic pancreatitis, and chronic cholecystitis
• Endocrine system diseases, such as hyperthyroidism, hypothyroidism, diabetes, and other diseases with clear hormone abnormalities
• Acute or chronic kidney diseases, blood system diseases, malignant tumors, and bone and joint diseases that affect activity
• No history of acute infection within 2 weeks
• Unable to cooperate with the examination
• Contraindications to cardiopulmonary exercise testing: acute myocardial infarction

Sponsors & Collaborators

• Affiliated Hospital of Changchun University of Chinese Medicine: lead

Study Sites (15)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Quanzhou First Hospital Affiliated to Fujian Medical University

Quanzhou, Fujian, 362000, China

Location

Guangdong Provincial People's Hospital Affiliated to Southern Medical University

Guangzhou, Guangdong, 510080, China

Location

Guangdong Provincial Hospital of Chinese Medicine

Guangzhou, Guangdong, 510120, China

Location

Jiangbin Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, 530021, China

Location

Daqing Oilfield General Hospital

Daqing, Heilongjiang, 163000, China

Location

The Second Hospital of Harbin Medical University

Harbin, Heilongjiang, 150086, China

Location

Anyang Regional Hospital of Puyang City, Henan Province

Puyang, Henan, 457000, China

Location

Zhengzhou Central Hospital Affiliated to Zhengzhou University

Zhengzhou, Henan, 450000, China

Location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Xiangya Second Hospital of Central South University

Changsha, Hunan, 410011, China

Location

Affiliated Hospital of Changchun University of Chinese Medicine

Changchun, Jilin, 130000, China

Location

Qilu Hospital of Shandong University

Jinan, Shangdong, 250012, China

Location

Tongji Hospital

Shanghai, Shanghai Municipality, 200065, China

Location

First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

Location

Related Publications (10)

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  PMID: 38942042 BACKGROUND

• Weeldreyer NR, De Guzman JC, Paterson C, Allen JD, Gaesser GA, Angadi SS. Cardiorespiratory fitness, body mass index and mortality: a systematic review and meta-analysis. Br J Sports Med. 2025 Feb 20;59(5):339-346. doi: 10.1136/bjsports-2024-108748.

  PMID: 39537313 BACKGROUND

• Wang J, Ren C, Xu S, Yuan Y, Song Y, Xie D, Wang K, Yuan L, Shen T, Xu L, Tang Y, Gao W, Zhao W. A reference equation for peak oxygen uptake for cycle ergometry in Chinese adult participants. Sci Rep. 2025 Mar 29;15(1):10876. doi: 10.1038/s41598-025-94207-7.

  PMID: 40157952 BACKGROUND

• Brazile TL, Levine BD, Shafer KM. Cardiopulmonary Exercise Testing. NEJM Evid. 2025 Feb;4(2):EVIDra2400390. doi: 10.1056/EVIDra2400390. Epub 2025 Jan 28.

  PMID: 39873542 BACKGROUND

• Kokkinos P, Kaminsky LA, Arena R, Zhang J, Myers J. A new generalized cycle ergometry equation for predicting maximal oxygen uptake: The Fitness Registry and the Importance of Exercise National Database (FRIEND). Eur J Prev Cardiol. 2018 Jul;25(10):1077-1082. doi: 10.1177/2047487318772667. Epub 2018 Apr 25.

  PMID: 29692203 BACKGROUND

• Kaminsky LA, Myers J, Arena R. Determining Cardiorespiratory Fitness With Precision: Compendium of Findings From the FRIEND Registry. Prog Cardiovasc Dis. 2019 Jan-Feb;62(1):76-82. doi: 10.1016/j.pcad.2018.10.003. Epub 2018 Oct 30.

  PMID: 30385268 BACKGROUND

• Daneshvar F, Weinreich M, Daneshvar D, Sperling M, Salmane C, Yacoub H, Gabriels J, McGinn T, Smith MC. Cardiorespiratory Fitness in Internal Medicine Residents: Are Future Physicians Becoming Deconditioned? J Grad Med Educ. 2017 Feb;9(1):97-101. doi: 10.4300/JGME-D-15-00720.1.

  PMID: 28261402 BACKGROUND

• de Souza E Silva CG, Kaminsky LA, Arena R, Christle JW, Araujo CGS, Lima RM, Ashley EA, Myers J. A reference equation for maximal aerobic power for treadmill and cycle ergometer exercise testing: Analysis from the FRIEND registry. Eur J Prev Cardiol. 2018 May;25(7):742-750. doi: 10.1177/2047487318763958. Epub 2018 Mar 8.

  PMID: 29517365 BACKGROUND

• Ashikaga K, Itoh H, Maeda T, Itoh H, Ichikawa Y, Tanaka S, Ajisaka R, Koike A, Makita S, Omiya K, Kato Y, Adachi H, Nagayama M, Tajima A, Harada N, Akashi YJ; Committee on Exercise Prescription for Patients (CEPP) Members. Ventilatory efficiency during ramp exercise in relation to age and sex in a healthy Japanese population. J Cardiol. 2021 Jan;77(1):57-64. doi: 10.1016/j.jjcc.2020.07.008. Epub 2020 Aug 5.

  PMID: 32768174 BACKGROUND

• Katzmarzyk PT, Friedenreich C, Shiroma EJ, Lee IM. Physical inactivity and non-communicable disease burden in low-income, middle-income and high-income countries. Br J Sports Med. 2022 Jan;56(2):101-106. doi: 10.1136/bjsports-2020-103640. Epub 2021 Mar 29.

  PMID: 33782046 BACKGROUND

MeSH Terms

Interventions

Exercise Test

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Central Study Contacts

Head of Cardiac Rehabilitation Department

CONTACT

+86 131 8088 9430; Xiopingmeng@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiac Rehabilitation Department

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 7, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)