Ultramarathons and Impact of Phased Electromagnetic Field Therapy (PEMF)
- Conditions
- Healthy
- Interventions
- Procedure: Pulsed Electromagnetic Field therapy (PEMF)Procedure: Pulsed Electromagnetic Field Sham therapy
- Registration Number
- NCT03333135
- Lead Sponsor
- Mayo Clinic
- Brief Summary
This research is being done to better understand the pulmonary consequences of completing an ultra marathon at altitude and a sea level city.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Healthy endurance trained individuals participating in the Ultra Trail du Mont Blanc (UTMB) and/or Hong Kong 100 ultramarathons
> 65 years age
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HK100 Pulsed Electromagnetic Field Pulsed Electromagnetic Field therapy (PEMF) 20 athletes (ideally a mix of elite and amateur level athletes and veteran (40-65y) and young (20-39y). Athletes will be recruited at the 2018 and 2019 Hong Kong 100 races. In addition, these athletes will use the pulsed electromagnetic field (PEMF) for the two weeks prior to the race. UTMB Pulsed Electromagnetic Field Pulsed Electromagnetic Field therapy (PEMF) 20 athletes (ideally a mix of elite and amateur level athletes and veteran (40-65y) and young (20-39y). Athletes will be recruited at the 2018 and 2019 Ultra Trail du Mont Blanc (UTMB) races. In addition, these athletes will use the pulsed electromagnetic field (PEMF) for the two weeks prior to the race. HK100 Pulsed Electromagnetic Field Sham Pulsed Electromagnetic Field Sham therapy 20 athletes (ideally a mix of elite and amateur level athletes and veteran (40-65y) and young (20-39y). Athletes will be recruited at the 2018 and 2019 Hong Kong 100 races. In addition, these athletes will use a PEMF device that doesn't produce electromagnetic fields (sham) for the two weeks prior to the race. UTMB Pulsed Electromagnetic Field Sham Pulsed Electromagnetic Field Sham therapy 20 athletes (ideally a mix of elite and amateur level athletes and veteran (40-65y) and young (20-39y). Athletes will be recruited at the 2018 and 2019 Ultra Trail du Mont Blanc (UTMB) races. In addition, these athletes will use a PEMF device that doesn't produce electromagnetic fields (sham) for the two weeks prior to the race.
- Primary Outcome Measures
Name Time Method Change in tricuspid annular plane systolic excursion (TAPSE) 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 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) 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) 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') 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 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.
- Secondary Outcome Measures
Name Time Method Change in cortisol baseline, within 2 hours of race completion, 24-48 hours post race Saliva levels of cortisol will be measured as a metric of stress. Cortisol levels increase when you body is under stress.
Change in hemoglobin baseline, within 2 hours of race completion, 24-48 hours post race A blood sample will be taken and analyzed to determine the amount of red blood cells and and hemoglobin in the blood. For males normal range for hemoglobin is 13.5-17.5 grams per deciliter and for females normal range for hemoglobin is 12.0-15.5 grams per deciliter. Low values means anemia is present and higher levels is a normal response to altitude.
Change in hematocrit baseline, within 2 hours of race completion, 24-48 hours post race A blood sample will be taken and analyzed to determine the amount of red blood cells and and hemoglobin in the blood. For males normal range for hematocrit is 38.8-50% and for females normal range for hematocrit is 34.9-44.5% Low values means anemia is present and higher levels is a normal response to altitude.
Change in exhaled nitric oxide baseline, within 2 hours of race completion, 24-48 hours post race The amount of nitric oxide in ones exhaled air will be measured by a handheld device. Levels under 25 parts per billion are normal, more than 35 parts per billion would be a sign of airway inflammation.
Change in cardiac troponin I baseline, within 2 hours of race completion, 24-48 hours post race To determine if signs of cardiac damage, as its presence in the blood is a potential sign of damage to the heart muscle
Change in B-type natriuretic peptide baseline, within 2 hours of race completion, 24-48 hours post race To determine if signs of cardiac damage, as its presence in the blood is a potential sign of damage to the heart muscle
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Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States