Clinical trial NCT03333135: Ultramarathons and Impact of Phased Electromagnetic Field Therapy (PEMF)
Official title: The Pulmonary Consequences of Participating in the UTMB and Hong Kong 100 Ultramarathons and Impact of Phased Electromagnetic Field Therapy (PEMF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Ultramarathons
Electromagnetic field therapy
Endurance
Exercise
Environmental conditions
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: Inclusion Criteria:

Healthy endurance trained individuals participating in the Ultra Trail du Mont Blanc (UTMB) and/or Hong Kong 100 ultramarathons

Exclusion Criteria:

\> 65 years age

Primary outcomes:
measure: Change in right ventricle end diastolic area (EDA)
timeFrame: baseline, within 2 hours of race completion, 24-48 hours post race
measure: Change in tricuspid annular plane systolic excursion (TAPSE)
timeFrame: baseline, within 2 hours of race completion, 24-48 hours post race
measure: Change in ratio between early mitral inflow velocity and mitral annular early diastolic velocity (E/e')
timeFrame: baseline, within 2 hours of race completion, 24-48 hours post race
measure: 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)
timeFrame: baseline, within 2 hours of race completion, 24-48 hours post race
measure: Change in lung fluid assessed through ultrasound incidence of comet tails
timeFrame: baseline, within 2 hours of race completion, 24-48 hours post race
measure: Change in lung fluid assessed through diffusion capacity of the lungs for carbon monoxide and nitric oxide
timeFrame: baseline, within 2 hours of race completion, 24-48 hours post race
Secondary outcomes:
measure: Change in exhaled nitric oxide
timeFrame: baseline, within 2 hours of race completion, 24-48 hours post race
measure: Change in hemoglobin
timeFrame: baseline, within 2 hours of race completion, 24-48 hours post race
measure: Change in hematocrit
timeFrame: baseline, within 2 hours of race completion, 24-48 hours post race
measure: Change in cardiac troponin I
timeFrame: baseline, within 2 hours of race completion, 24-48 hours post race
measure: Change in B-type natriuretic peptide
timeFrame: baseline, within 2 hours of race completion, 24-48 hours post race
measure: Change in cortisol
timeFrame: baseline, within 2 hours of race completion, 24-48 hours post race
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Bruce D Johnson
role: PRINCIPAL_INVESTIGATOR
References: