Oxygen ConsumptionMCCS-CCPETSNCT07108296
A Study on Cardiopulmonary Exercise Tolerance Standards for Healthy Chinese Population
An observational study of Oxygen Consumption and Cardiorespiratory Fitness, run by Affiliated Hospital of Changchun University of Chinese Medicine at 15 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxygen Consumption, Cardiorespiratory Fitness
- What is being tested?
- cardiopulmonary exercise testing (CPET)
- How many people
- 4,620 participants
- Where
- 15 sitesChina
- Study dates
- 1 Sep 2025to 30 Mar 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy individuals aged 18 - 65.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- No history of acute infection within 2 weeks
- Unable to cooperate with the examination
- Contraindications to cardiopulmonary exercise testing: acute myocardial infarction
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Rongjing R Ding, MD, +86 13552548612
Affiliated Hospital of Changchun University of Chinese Medicine
Changchun, Jilin, 130000
Head of Cardiac Rehabilitation Department, +86 131 8088 9430, Xiopingmeng@126.com
Xiangya Second Hospital of Central South University
Changsha, Hunan, 410011
Danyan D Xu, MD, +86 13974874636
Daqing Oilfield General Hospital
Daqing, Heilongjiang, 163000
Zhiqing Z Fan, MD, +86 13836769588
Guangdong Provincial People's Hospital Affiliated to Southern Medical University
Guangzhou, Guangdong, 510080
Huan H Ma, MD, +86 15018755932
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, 510120
Wei W Jiang, MD, +86 15630050688
The Second Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086
Jian J Wu, MD, +86 15245001123
Qilu Hospital of Shandong University
Jinan, Shangdong, 250012
Lin L Shen, MD, +86 18560082257
Jiangbin Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021
Youcai Y Hu, MD, +86 13978870585
Anyang Regional Hospital of Puyang City, Henan Province
Puyang, Henan, 457000
Hui H Liu, MD, +86 13903727688
Quanzhou First Hospital Affiliated to Fujian Medical University
Quanzhou, Fujian, 362000
Ruozhu R Dai, +86 18960337219
Tongji Hospital
Shanghai, Shanghai Municipality, 200065
Head of Cardiac Rehabilitation Department, +86 13661615008
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
Cuntai C Zhang, MD, +86 15927668408
First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, 710061
Fenling F Fan, MD, +86 15182916660
Zhengzhou Central Hospital Affiliated to Zhengzhou University
Zhengzhou, Henan, 450000
Dongwei D Wang, +86 18937633428
About this study
Official title: Multi-center Clinical Cohort Study on Cardiopulmonary Exercise Tolerance Standards in Chinese Healthy Population
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.
Read more
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
- Being tested
- cardiopulmonary exercise testing (CPET)
- Keywords
- Peak Oxygen Uptake, VO2@AT, Cardiopulmonary Exercise Tolerance, Prediction Model, Healthy Population
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Chinese Age-Sex-Stratified Cardiopulmonary Function Cohort (CACSF Cohort) | Not described Receives: Other: cardiopulmonary exercise testing (CPET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: On the day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Oxygen ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 4,620 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Changchun University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoping Meng, Affiliated Hospital of Changchun University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108296
- Sponsor's protocol ID
- KFKT-2025-KY-010
- Other IDs
- KFKT-2025-KY-010
- Acronym
- MCCS-CCPETS
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: all IPD collected throughout the trial, only IPD used in the results publication
Publications
Strain T, Flaxman S, Guthold R, Semenova E, Cowan M, Riley LM, Bull FC, Stevens GA; Country Data Author Group. National, regional, and global trends in insufficient physical activity among adults from 2000 to 2022: a pooled analysis of 507 population-based surveys with 5.7 million participants. Lancet Glob Health. 2024 Aug;12(8):e1232-e1243. doi: 10.1016/S2214-109X(24)00150-5. Epub 2024 Jun 25.
PubMed 38942042Weeldreyer 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.
PubMed 39537313Wang 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.
PubMed 40157952Brazile TL, Levine BD, Shafer KM. Cardiopulmonary Exercise Testing. NEJM Evid. 2025 Feb;4(2):EVIDra2400390. doi: 10.1056/EVIDra2400390. Epub 2025 Jan 28.
PubMed 39873542Kokkinos 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.
PubMed 29692203Kaminsky 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.
PubMed 30385268Daneshvar 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.
PubMed 28261402de 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.
PubMed 29517365Ashikaga 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.
PubMed 32768174Katzmarzyk 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.
PubMed 33782046
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Clinical Cohort Study on Cardiopulmonary Exercise Tolerance Standards in Chinese Healthy Population
- ClinicalTrials.gov ID
- NCT07108296
- Acronym / sponsor ID
- MCCS-CCPETS / KFKT-2025-KY-010
- Conditions
- Oxygen Consumption, Cardiorespiratory Fitness
- Keywords
- Peak Oxygen Uptake, VO2@AT, Cardiopulmonary Exercise Tolerance, Prediction Model, Healthy Population
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,620 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Changchun University of Chinese MedicineUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chinese Age-Sex-Stratified Cardiopulmonary Function Cohort (CACSF Cohort) | – | Other: cardiopulmonary exercise testing (CPET) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy individuals aged 18 - 65.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiopulmonary exercise testing (CPET)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. | Other | Chinese Age-Sex-Stratified Cardiopulmonary Function Cohort (CACSF Cohort) |
Primary outcome
Peak Oxygen Uptake
Time frame: On the day of enrollment
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Background: PubMed 38942042Strain T, Flaxman S, Guthold R, Semenova E, Cowan M, Riley LM, Bull FC, Stevens GA; Country Data Author Group. National, regional, and global trends in insufficient physical activity among adults from 2000 to 2022: a pooled analysis of 507 population-based surveys with 5.7 million participants. Lancet Glob Health. 2024 Aug;12(8):e1232-e1243. doi: 10.1016/S2214-109X(24)00150-5. Epub 2024 Jun 25.
- Background: PubMed 39537313Weeldreyer 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.
- Background: PubMed 40157952Wang 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.
- Background: PubMed 39873542Brazile TL, Levine BD, Shafer KM. Cardiopulmonary Exercise Testing. NEJM Evid. 2025 Feb;4(2):EVIDra2400390. doi: 10.1056/EVIDra2400390. Epub 2025 Jan 28.
- Background: PubMed 29692203Kokkinos 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.
- Background: PubMed 30385268Kaminsky 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.
- Background: PubMed 28261402Daneshvar 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.
- Background: PubMed 29517365de 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.
- Background: PubMed 32768174Ashikaga 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.
- Background: PubMed 33782046Katzmarzyk 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.
- Individual participant dataSharing planned: No. all IPD collected throughout the trial, only IPD used in the results publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxygen Consumption and Cardiorespiratory Fitness, run by Affiliated Hospital of Changchun University of Chinese Medicine at 15 sites 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 8 inclusion and 9 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: opening soon, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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 Head of Cardiac Rehabilitation Department (+86 131 8088 9430, Xiopingmeng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Oxygen Uptake (time frame: On the day of enrollment). 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 NCT07108296, which also lists 10 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 11 Aug 2025.