The Pulmonary Consequences of Participating in the UTMB and Hong Kong 100 Ultramarathons and Impact of Phased Electromagnetic Field Therapy (PEMF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change in tricuspid annular plane systolic excursion (TAPSE)
研究概览
简要总结
This research is being done to better understand the pulmonary consequences of completing an ultra marathon at altitude and a sea level city.
详细描述
Subjects will be asked to undertake three (3) sets of assessments at prescribed time intervals: Baseline (at 72-24h prior to each event), immediately post (within 2h of race completion) and during recovery (within 24-48h of race completion). Each assessment will consist of 1)lung function tests; 2) a saliva and blood sample; 3) a lung and cardiac ultrasound. Subjects will be recruited from a range of age groups and fitness levels, before being divided into a sham or therapy group. Groups will use Pulsed Electromagnetic Field (PEMF) therapy or related sham before the event and during recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Study team and participants will not know if they have received the PEMF therapy or the sham
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy endurance trained individuals participating in the Ultra Trail du Mont Blanc (UTMB) and/or Hong Kong 100 ultramarathons
排除标准
- •> 65 years age
结局指标
主要结局
Change in tricuspid annular plane systolic excursion (TAPSE)
时间窗: baseline, within 2 hours of race completion, 24-48 hours post race
Another ultrasound metric that will be evaluated is tricuspid annular plane systolic excursion (TAPSE) which is used a parameter of global RV function which describes apex-to-base shortening. Normal value for TAPSE is above 16 mm.
Change in lung fluid assessed through ultrasound incidence of comet tails
时间窗: baseline, within 2 hours of race completion, 24-48 hours post race
Ultrasound will be used to image 28 "windows" covering the 2nd through the 5th intercostal/rib space on the right and left sides of the chest. The number of comet tails observed over these 28 locations will be documented and the change in this number over the course of the study will be evaluated.
Change in right ventricle end diastolic area (EDA)
时间窗: baseline, within 2 hours of race completion, 24-48 hours post race
Cardiac ultrasound (Philips CX50) will be performed to determine left and right ventricular morphology and function. Ultrasound will be performed in accordance with the recommendations of the American Society of Echocardiography guidelines (ASE). Imaging of the ventricles and the diameter during relaxation (diastole) will be captured and evaluated. Normal value for right ventricle EDA indexed to body surface area ranges between 5-12.6 cm\^2/m\^2 for males and 4.5-11.5 cm\^2/m\^2 for females .
Change in the ratio of peak velocity flow in early diastole (the E wave) to peak velocity flow in late diastole caused by atrial contraction (the A wave)
时间窗: baseline, within 2 hours of race completion, 24-48 hours post race
Another ultrasound metric that will be evaluated is he ratio of peak velocity flow in early diastole (the E wave) to peak velocity flow in late diastole caused by atrial contraction (the A wave) (E/A) which is used to evaluate the diastolic filling of the left ventricle. Normal value for E/A is between 0.8 and 2.
Change in ratio between early mitral inflow velocity and mitral annular early diastolic velocity (E/e')
时间窗: baseline, within 2 hours of race completion, 24-48 hours post race
Another ultrasound metric that will be evaluated is early mitral inflow velocity and mitral annular early diastolic velocity (E/e') which is used to evaluate the diastolic or relaxation function of the left ventricle. Normal value for E/e' is \<6.
Change in lung fluid assessed through diffusion capacity of the lungs for carbon monoxide and nitric oxide
时间窗: baseline, within 2 hours of race completion, 24-48 hours post race
Subjects will take a maximal breath of a test gas mixture, hold that inhalation for 4 seconds and then exhale and the exhaled gas will be analyze to determine the change in gas concentrations between what was inhaled and exhaled. Comparison will be made between the change over time in this ability of gas to move from the lungs to the blood stream.
次要结局
- Change in cortisol(baseline, within 2 hours of race completion, 24-48 hours post race)
- Change in hemoglobin(baseline, within 2 hours of race completion, 24-48 hours post race)
- Change in hematocrit(baseline, within 2 hours of race completion, 24-48 hours post race)
- Change in cardiac troponin I(baseline, within 2 hours of race completion, 24-48 hours post race)
- Change in exhaled nitric oxide(baseline, within 2 hours of race completion, 24-48 hours post race)
- Change in B-type natriuretic peptide(baseline, within 2 hours of race completion, 24-48 hours post race)
研究者
Bruce Johnson
Principal Investigator
Mayo Clinic