CompletedNot Applicable

Hypoxic Environment on EIB and Performance in Race Walkers

China64 participantsStarted 2025-07-16

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Only athletes who meet the following conditions simultaneously can be included in this study: * Engaged in race walking specialized training; * The athlete's technical grade reaches the national first-class standard or above (the athlete's level level is ≥ Tier 3); * Regular professional training is still maintained at present. Exclusion Criteria: * Presence of chronic cardiopulmonary diseases (e.g., chronic obstructive pulmonary disease, pulmonary heart disease, known structural heart disease) or other significant medical conditions (e.g., uncontrolled hypertension, depression) that could confound respiratory test results or pose a risk during intense exercise; * Known hypersensitivity to hypoxia or history of severe altitude sickness (e.g., high-altitude pulmonary edema \[HAPE\], high-altitude cerebral edema \[HACE\]); * Sickle cell trait or disease; * History of chest surgery within the preceding 6 months; * Any active lung infection (e.g., pneumonia, bronchitis) or systemic infection within 3 weeks before the examination; * Cessation of regular training for 2 or more weeks immediately before the examination, to ensure participants were in their typical training state; * Experience of a moderate or severe upper respiratory tract infection (e.g., common cold) within the week preceding the examination; * Individuals who reported chest pain or experienced syncope (fainting) during the spirometry maneuver; * Individuals who were unable to understand the…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of Exercise-Induced Bronchoconstriction

Timeframe: Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training)

Maximum Percentage Fall in FEV1 (FEV1 Decline Rate)

Timeframe: Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training)

Trial details

NCT IDNCT07466849

SponsorShanghai University of Sport

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-10-16

View on ClinicalTrials.gov More Exercise-induced Bronchoconstriction (EIB) trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Incidence of Exercise-Induced Bronchoconstriction

Timeframe: Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training)

Maximum Percentage Fall in FEV1 (FEV1 Decline Rate)

Timeframe: Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training)