ClinicalTrials.gg
CompletedNCT03333135Updated Apr 11, 2022

Ultramarathons and Impact of Phased Electromagnetic Field Therapy (PEMF)

An interventional study of Pulsed Electromagnetic Field therapy (PEMF) and Pulsed Electromagnetic Field Sham therapy in Healthy, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-11.

Sponsored by Mayo Clinic · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 10 months after the study started (first participant enrolled Dec 2016, registered Oct 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 42 studies in Motor Activity by Mayo Clinic — 4 open to participants now, 5 under way, none of them phase 3. Motor Activity · Mayo Clinic.

Enrollment
11th of 36
72 · median 53
Started
2016
with 5 others
No phase
28 of 42
3 open now
Registered
25th of 42
by date

Among the 42 studies in Motor Activity by Mayo Clinic, this one is the 11th largest by enrollment of the 36 interventional ones that give a count, is one of 6 that started in 2016, is one of 28 with no phase, and was the 25th registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

4 of the 42 studies in Motor Activity by Mayo Clinic are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 4 open studies →

Where they have run

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 42 studies in Motor Activity by Mayo Clinic, or all of them as a file.
02

Study summary

This research is being done to better understand the pulmonary consequences of completing an ultra marathon at altitude and a sea level city.

Read the 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.

03

Conditions studied

  • Healthy

Browse trials for

Keywords

  • Ultramarathons
  • Electromagnetic field therapy
  • Endurance
  • Exercise
  • Environmental conditions
04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

> 65 years age

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    HK100 Pulsed Electromagnetic Field

    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.

    Procedure: Pulsed Electromagnetic Field therapy (PEMF)

  • Sham comparator
    HK100 Pulsed Electromagnetic Field Sham

    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.

    Procedure: Pulsed Electromagnetic Field Sham therapy

  • Experimental
    UTMB Pulsed Electromagnetic Field

    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.

    Procedure: Pulsed Electromagnetic Field therapy (PEMF)

  • Sham comparator
    UTMB Pulsed Electromagnetic Field Sham

    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.

    Procedure: Pulsed Electromagnetic Field Sham therapy

Interventions

  • ProcedurePulsed Electromagnetic Field therapy (PEMF)

    PEMF Therapy based on Biological Electromagnetic (BEM) microbial wave technology provides micro-magnetic emissions to the center of the palm (Laogong acupoint). While participating in the study, the subjects will undertake 2 sessions of therapy every day (1 session in the morning and evening). Each session will last for 16-min (8-min for left and 8-min for right hand).

    Also known as: Bioboosti

  • ProcedurePulsed Electromagnetic Field Sham therapy

    PEMF therapy will be administered however it will not produce micro-magnetic emissions. The therapy will be used on the center of the palm (Laogong acupoint) of each hand. While participating in the study, the subjects will undertake 2 sessions of therapy every day (1 session in the morning and evening). Each session will last for 16-min (8-min for left and 8-min for right hand).

    Also known as: Bioboosti Sham

06

What researchers measure

Primary outcomes

  1. Change in right ventricle end diastolic area (EDA)

    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 .

    Time frame: baseline, within 2 hours of race completion, 24-48 hours post race

  2. Change in tricuspid annular plane systolic excursion (TAPSE)

    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.

    Time frame: baseline, within 2 hours of race completion, 24-48 hours post race

  3. Change in ratio between early mitral inflow velocity and mitral annular early diastolic velocity (E/e')

    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.

    Time frame: baseline, within 2 hours of race completion, 24-48 hours post race

  4. 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)

    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.

    Time frame: baseline, within 2 hours of race completion, 24-48 hours post race

  5. Change in lung fluid assessed through ultrasound incidence of comet tails

    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.

    Time frame: baseline, within 2 hours of race completion, 24-48 hours post race

  6. Change in lung fluid assessed through diffusion capacity of the lungs for carbon monoxide and nitric oxide

    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.

    Time frame: baseline, within 2 hours of race completion, 24-48 hours post race

Secondary outcomes

  1. Change in exhaled nitric oxide

    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.

    Time frame: baseline, within 2 hours of race completion, 24-48 hours post race

  2. Change in hemoglobin

    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.

    Time frame: baseline, within 2 hours of race completion, 24-48 hours post race

  3. Change in hematocrit

    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.

    Time frame: baseline, within 2 hours of race completion, 24-48 hours post race

  4. Change in cardiac troponin I

    To determine if signs of cardiac damage, as its presence in the blood is a potential sign of damage to the heart muscle

    Time frame: baseline, within 2 hours of race completion, 24-48 hours post race

  5. Change in B-type natriuretic peptide

    To determine if signs of cardiac damage, as its presence in the blood is a potential sign of damage to the heart muscle

    Time frame: baseline, within 2 hours of race completion, 24-48 hours post race

  6. Change in cortisol

    Saliva levels of cortisol will be measured as a metric of stress. Cortisol levels increase when you body is under stress.

    Time frame: baseline, within 2 hours of race completion, 24-48 hours post race

07

Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2016 to primary completion in Jun 2021, 54 months.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's 54 months is above that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 27, 2017
First posted
Nov 6, 2017
StartActual
Dec 12, 2016
Primary completionActual
Jun 15, 2021
CompletionActual
Jun 15, 2021
Last update
Apr 11, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03333135
Lead sponsor
Mayo Clinic
Responsible party
Bruce Johnson (Principal Investigator, Mayo Clinic) — Principal investigator
First posted
Nov 6, 2017
Start date
Dec 12, 2016
Primary completion
Jun 15, 2021
Completion
Jun 15, 2021
Last update
Apr 11, 2022

Study contacts

Bruce D Johnson
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion