Effects of Hypoxic Environment on Exercise-Induced Bronchoconstriction and Competitive Performance in Race Walkers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Incidence of Exercise-Induced Bronchoconstriction
研究概览
简要总结
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.
详细描述
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. 2. What will you need to do in this study?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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 test instructions or unwilling to cooperate fully with the testing procedures, as determined by the research staff.
研究组 & 干预措施
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
干预措施: High-Altitude Training & Hypoxic Environment Exposure (Other)
结局指标
主要结局
Incidence of Exercise-Induced Bronchoconstriction
时间窗: Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training)
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.
Maximum Percentage Fall in FEV1 (FEV1 Decline Rate)
时间窗: Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training)
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.
次要结局
- 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))
- 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))
- Forced Vital Capacity (FVC)(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))
- Peak expiratory flow (PEF)(Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training))
- Serum Levels of Clara Cell Protein 16(Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training))
- Serum Interleukin-6 (IL-6) Concentration(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))
- Vital Capacity (VC)(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(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(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(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))
- Resting heart rate(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.)
- Hematocrit (Hct)(Week 3 (baseline), Week 5 (initial altitude training), and Week 12 (final altitude training))
- Average heart rate during exercise(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(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(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.)
- Hemoglobin (Hb)(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(Baseline (Week 3 competition), Week 5 (competition), Week 12 (competition))
- Competition completion time(Baseline (Week 3 competition), Week 5 (competition), Week 12 (competition))
- Pace variability (coefficient of variation)(Baseline (Week 3 competition), Week 5 (competition), Week 12 (competition))
- Number of fouls committed(Baseline (Week 3 competition), Week 5 (competition), Week 12 (competition))
研究者
Zhi, Cao
Principal Investigator
Shanghai University of Sport