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Title: Diagnosis and Impact of Exercise-Induced Bronchoconstriction (EIB) in Athletes During Altitude Training
Study Description:
We invite you to participate in a research study examining Exercise-Induced Bronchoconstriction (EIB) in athletes. Your participation is entirely voluntary, and you may withdraw at any time without penalty. This study will take place over 2 to 4 months and includes both plains training and altitude training phases.
Why is this study being done?
The purpose of this study is threefold:
To diagnose whether you have EIB (a condition that causes narrowing of the airways during or after exercise).
To determine if altitude training induces or worsens EIB.
To understand how having (or not having) EIB affects your athletic performance during altitude training.
What will you be asked to do?
You will be asked to complete the following procedures four times each (with about 2 weeks between each session):
Blood Draws: Early morning fasting blood samples (approx. 4 ml from your arm). These are routine tests for the sports team.
Exercise Challenge Tests: You will run on a treadmill while wearing a heart rate monitor. This test follows standard safety guidelines (ATS). Your breathing will be tested before exercise and several times after. These are routine tests for the sports team.
VO2max Tests: You will run on a treadmill with a breathing mask to measure your maximum oxygen uptake. You will run until exhaustion, following a standardized protocol.
Questionnaires: You will wear a heart rate monitor during training and complete short questionnaires about your breathing and how hard you feel you are exercising.
How long will participation last? The total study duration is 2-4 months. Individual tasks take between 3 minutes (blood draw) and 50 minutes (exercise challenge).
What are the risks?
Blood Draw: Possible dizziness, bruising, or discomfort at the needle site.
Breathing Tests: You may feel briefly dizzy or tired from blowing hard; this passes quickly. Chest pain is very rare.
Exercise Tests: You will experience muscle fatigue and soreness. If you have EIB, you may feel short of breath, wheeze, or feel chest tightness. If symptoms become severe, the test will be stopped. Salbutamol (a standard asthma medication) may be given to relieve symptoms. Using salbutamol as described in this study is permitted under WADA anti-doping rules.
What are the benefits?
If you do not have EIB, you will receive an educational booklet on preventing EIB.
If you do have EIB, you will receive a detailed report for your coach, personalized strategies, and long-term follow-up support.
Compensation:
If you complete the entire study, you will receive a commemorative gift. No compensation is provided for partial participation.
Contact for Questions:
If you have any questions about the study or your rights as a participant, please contact the principal investigator listed on the consent form or email the Shanghai Sports University Research Ethics Committee at lunli@sus.edu.cn.
We invite you to participate in this research study. Your participation is entirely voluntary, and you may refuse to participate or withdraw from the experiment at any time without any penalty.
Before deciding whether to participate, you need to understand the content of this study, the potential risks and benefits of participation, and what you will be asked to do in this study. You may also consult with your family, friends, or doctor about this study and this consent form. If you have any questions about this study or this consent form, please contact the principal investigator and collaborating researchers. If you decide to participate in this study, you must sign this consent form. We will provide you with a signed copy of this consent form for your records.
What are the objectives of this study? Objective 1: To diagnose whether you have exercise-induced bronchoconstriction (EIB).
Objective 2: To investigate whether EIB is induced or aggravated at different stages of your altitude training period.
Objective 3: To investigate the impact of having or not having EIB on your specific athletic performance during altitude training.
What will you need to do in this study?
Over the next 2 to 4 months, you are required to follow and cooperate with the researchers' instructions. If you have any questions or feel unwell, please communicate with the research team promptly. The specific details are as follows:
1. The athlete is unable to maintain the predetermined speed of the protocol or voluntarily requests to stop; 2. VO2 no longer increases, showing a plateau phenomenon for more than 30 seconds; 3. The exercise heart rate exceeds 10% of the calculated maximum heart rate [(211 - 0.64 × age) - 10 bpm].
4. Wear a Polar heart rate monitor before each specialized training session and remove it after the session. Complete the RPE (Rating of Perceived Exertion) and exercise-related respiratory symptom questionnaires.
3. How long will it take to participate in this study?
The entire process will take approximately 2 to 4 months (depending on actual progress) and includes two phases: plains training and altitude training. The time commitments are as follows:
Each blood draw will take approximately 3 to 5 minutes. Each exercise-induced bronchoconstriction test, including a brief warm-up and wearing a Polar heart rate monitor, will take approximately 40 to 50 minutes.
Each VO2max test will take approximately 20 to 30 minutes. Each fitting and calibration of the Polar watch will take approximately 5 to 10 minutes.
Each post-training questionnaire will take approximately 2 to 5 minutes.
4. What are the potential risks or discomforts?
Known risks associated with this type of research include:
Blood collection: You may feel dizzy during the blood draw. If this occurs, please inform the researcher immediately. Additionally, the collection site may sometimes become red, painful, bruised, bleed, or become infected.
Pulmonary function test: Due to the forceful exhalation required, you may experience temporary dizziness for approximately 20 seconds or respiratory muscle fatigue, which are normal physiological responses and will typically recover within 0.5 to 1 minute after each test. There is a very low probability of experiencing chest pain. If this occurs, you must inform the researcher immediately and indicate your willingness and ability to continue with the test.
Laboratory exercise-induced bronchoconstriction test and VO2max test: These may result in exercise-induced fatigue (100% likelihood) and delayed onset muscle soreness (moderate likelihood). If you have EIB, you may experience respiratory discomfort during the test, such as difficulty breathing, excessive wheezing, or chest tightness. In principle, to ensure the accuracy of the study, we hope you will persist as much as possible. However, if you feel you cannot continue, please signal to us immediately, and we will terminate the test promptly. If necessary, we may provide 400 µg of salbutamol aerosol (200 µg × 2 puffs) to alleviate your symptoms.
Note: Salbutamol is a standard medication (bronchodilator) used to treat acute EIB episodes. According to the latest policies of the IOC Medical Committee and the World Anti-Doping Agency (2024), inhaled salbutamol in aerosol form, with a single dose ≤400 µg and a cumulative dose over 24 hours ≤800 µg, falls within the therapeutic use exemption range and does not constitute a doping violation. Therefore, in the event of such a situation, the decision to use it will be made jointly based on the opinions of you, your head coach, and the medical officer responsible.
5. What are the potential benefits of participating in this study? If you do not have EIB: You will receive a simplified version of the "EIB Prevention and Management Handbook" compiled by us, which will help you properly understand the mechanisms, hazards, and protective measures related to EIB, and prevent the occurrence of EIB.
If you have EIB: After the experiment concludes, we will provide the coaching staff with a detailed report on your specific condition and work together with them to develop intervention strategies and conduct periodic evaluations. You will be added to our EIB athlete registry, and we will provide follow-up (1-2 times per year) as well as EIB consultation services to help you mitigate the negative effects of EIB.
6. Will you receive compensation for participating in this study? Upon completing the entire experiment, you will receive a reward: one commemorative gift.
If you withdraw from the study, whether voluntarily or involuntarily, you will not receive the reward.
7. What if you get injured while participating in this research? For any organic injuries you may suffer as a result of participating in this research, Shanghai Sports University will not cover your medical expenses or provide any other form of financial compensation. You will not waive any of your legal rights by signing this consent form.
8. Can one leave the study halfway? You can withdraw at any time without any penalty.
9. How will this research protect your personal privacy? The experimental data and informed consent forms will be encrypted using codes and pseudonyms, ensuring that your personal information is not disclosed or directly identifiable from the relevant data.
10. The Research Ethics Committee of Shanghai University of Sport and how it protects you? This committee will review all studies involving human subjects, such as the study you are considering participating in. The committee is responsible for protecting the rights and welfare of research participants. The committee complies with national laws and guidelines, reviews each study to ensure that the risks of all research projects are minimized as much as possible.
If you have any doubts about the rights of the subjects, or if you think you have been treated unfairly, or if you have any questions about this study, you can contact the committee. The contact information is provided below.
11. Who can you contact if you have any questions? If you have any questions, confusion, complaints regarding participation in this research, or any doubts about your rights as a research subject, you can contact the main researcher and contact person listed on the first page of this consent form. You can also directly contact the Shanghai Sports University Research Ethics Committee at the email address lunli@sus.edu.cn.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Race Walking Athletes | A single cohort of 64 provincial-level race walking athletes (35 males, 29 females). The cohort undergoes baseline and follow-up testing at sea level (0-153m), followed by an 8-week high-altitude training program (1880-2030m). They are assessed for lung function and risk of exercise-induced bronchoconstriction (EIB) across several distinct testing stages |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Altitude Training & Hypoxic Environment Exposure | Other | Athletes underwent an 8-week race walking training program in a high-altitude environment (1880-2030m). This exposure is compared to a baseline period at sea level (0-153m) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Exercise-Induced Bronchoconstriction | The incidence of EIB is defined as the percentage of athletes diagnosed with a positive EIB status. A positive diagnosis is confirmed if there is a fall in Forced Expiratory Volume in 1 second (FEV1) of ≥10% from the pre-exercise baseline value, following a standardized laboratory bronchial provocation test. Lung function is measured pre-exercise and at 1, 3, 5, 7, 10, and 15 minutes post-exercise. | Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training) |
| Maximum Percentage Fall in FEV1 (FEV1 Decline Rate) | The maximum percentage decrease in FEV1 following the laboratory bronchial provocation test, compared to the pre-exercise baseline value. The decline rate is calculated to assess the severity of exercise-induced airway narrowing. | Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training) |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Levels of Clara Cell Protein 16 | CC16 is measured via Enzyme-Linked Immunosorbent Assay (ELISA) from fasting venous blood samples. It serves as a biomarker for airway epithelial damage and increased barrier permeability due to high-altitude hypoxic and dry environmental exposure. | Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training) |
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Inclusion Criteria:
Only athletes who meet the following conditions simultaneously can be included in this study:
Exclusion Criteria:
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This study aims to enroll active race walking athletes with a minimum technical grade of National First-Class (≥ Tier 3). The target population represents well-trained endurance athletes currently preparing for or competing in national-level events. Participants are expected to be free from injury and in a consistent training macrocycle to ensure the validity of the physiological assessments.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing Institute of Sports Science | Chongqing | China |
The data collected in this study involve sensitive physiological and health information of elite athletes exposed to hypoxic conditions. Due to the following reasons, individual participant data will not be shared:
Privacy concerns: The data contain identifiable information about athletes' health status and training responses, which could potentially be traced back to individuals given the small sample size of elite athlete populations.
Ethical restrictions: The informed consent form signed by participants explicitly limits data usage to this specific study and does not include permission for broad public data sharing.
Competitive sensitivity: Data on athletes' responses to hypoxia could be considered performance-sensitive information.
Aggregated, de-identified data will be presented in the published manuscript and supplementary materials.
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| D000532 | Altitude Sickness |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
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| Serum Interleukin-6 (IL-6) Concentration | Fasting serum IL-6 levels are quantified using ELISA to evaluate the systemic inflammatory response induced by intensive exercise in a high-altitude environment. | Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training) |
| Serum level of Immunoglobulin E | Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training) |
| White blood cell count | Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training) |
| Neutrophil count | Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training) |
| Eosinophil count | Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training) |
| Vital Capacity (VC) | Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training) |
| Forced Vital Capacity (FVC) | Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training) |
| Peak expiratory flow (PEF) | Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training) |
| Maximal oxygen consumption (VO2max) | Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training) |
| Minute ventilation volume (Ve) | Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training) |
| Tidal volume (Tv) | Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training) |
| Resiratory frequency (Rf) | Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training) |
| Total distance covered per training session | Total distance covered during each training session, measured using a Garmin watch (GPS). Reported in kilometers (km). For each time point, the average distance per session over a [e.g., 1-week] period will be calculated and reported as mean ± standard deviation. | Through study completion, an average of 12 weeks. Daily training data are collected continuously and summarized as total/weekly averages at the end of the study. |
| Exercise Time / Duration | Total duration of each training session, measured using a Garmin watch. Reported in minutes (min). For each time point, the average duration per session over a [e.g., 1-week] period will be calculated and reported as mean ± standard deviation. | Through study completion, an average of 12 weeks. Daily training data are collected continuously and summarized as total/weekly averages at the end of the study. |
| Average speed per training session | Average speed during each training session, calculated from total distance and duration, measured using a Garmin watch. Reported in km/h. For each time point, the average speed per session over a 1-week period will be calculated and reported as mean ± SD. | Through study completion, an average of 12 weeks. Daily training data are collected continuously and summarized as total/weekly averages at the end of the study. |
| Resting heart rate | Resting heart rate measured using Polar heart rate monitor. Participants were instructed to rest in a supine position for 10 minutes before measurement. Heart rate was recorded in beats per minute (bpm). Reported as mean ± standard deviation for each time point. | Through study completion, an average of 12 weeks. Daily training data are collected continuously and summarized as total/weekly averages at the end of the study. |
| Average heart rate during exercise | Continuous heart rate monitoring during each training session using Polar heart rate monitor. Average heart rate for each session was calculated and reported in beats per minute (bpm). At each study time point, the average of all sessions in that week was calculated and reported as mean ± standard deviation. | Through study completion, an average of 12 weeks. Daily training data are collected continuously and summarized as total/weekly averages at the end of the study. |
| Maximum heart rate during exercise | Maximum heart rate measured immediately during training, using Polar heart rate monitor. Heart rate recovery was reported in beats per minute (bpm). Reported as mean ± standard deviation. | Through study completion, an average of 12 weeks. Daily training data are collected continuously and summarized as total/weekly averages at the end of the study. |
| Rate of Perceived Exertion (RPE) Score | Perceived exertion assessed using the Borg CR10 scale. Participants rate their overall exertion on a scale from 1 (very light) to 10 (maximal exertion), with higher scores indicating greater perceived fatigue. Assessed immediately after each exercise test. Reported as mean ± standard deviation for each time point. | Through study completion, an average of 12 weeks. Daily training data are collected continuously and summarized as total/weekly averages at the end of the study. |
| Red blood cell count (RBC) | Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training) |
| Hemoglobin (Hb) | Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training) |
| Hematocrit (Hct) | Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training) |
| Red blood cell distribution width (RDW) | Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training) |
| Serum hormone (Testosterone/Cortisol) | Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training) |
| Blood Glucose | Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training) |
| Blood urea | Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training) |
| Blood creatinine | Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training) |
| Blood creatine kinase (CK) | Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training) |
| Blood lactate dehydrogenase (LDH) | Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training) |
| Incidence of acute altitude sickness (assessed by Lake Louise Score) | Through study completion, an average of 3 months |
| Adverse events related to hypoxic exposure | Through study completion, an average of 3 months |
| Competition ranking | Official final ranking position achieved in each competition. Data obtained from official competition results. Rankings are reported as the best, worst, and average ranking across all competitions during each study period (or as median [range]). | Baseline (Week 3 competition), Week 5 (competition), Week 12 (competition) |
| Competition completion time | Total time taken to complete each official competition, obtained from official timing data. Reported in minutes and seconds (mm:ss) or in seconds. For each study time point, the average completion time of all competitions in that period is calculated and reported as mean ± standard deviation (or median [IQR] if not normally distributed). | Baseline (Week 3 competition), Week 5 (competition), Week 12 (competition) |
| Pace variability (coefficient of variation) | Within-competition pace stability calculated as the coefficient of variation (CV) of split times or lap paces. CV = (standard deviation of pace / mean pace) × 100%. Lower values indicate more consistent pacing. Calculated from official competition data. Reported as mean ± standard deviation for each study time point. | Baseline (Week 3 competition), Week 5 (competition), Week 12 (competition) |
| Number of fouls committed | Total number of fouls committed by the athlete during each official competition, obtained from official competition records. For each study time point, the total number of fouls across all competitions in that period is reported. | Baseline (Week 3 competition), Week 5 (competition), Week 12 (competition) |
| D012140 | Respiratory Tract Diseases |