HealthyNCT03333135
Ultramarathons and Impact of Phased Electromagnetic Field Therapy (PEMF)
A study testing Pulsed Electromagnetic Field therapy (PEMF) in people with Healthy, run by Mayo Clinic at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pulsed Electromagnetic Field therapy (PEMF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2016to 15 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy endurance trained individuals participating in the Ultra Trail du Mont Blanc (UTMB) and/or Hong Kong 100 ultramarathons
Who cannot join
- > 65 years age
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: The Pulmonary Consequences of Participating in the UTMB and Hong Kong 100 Ultramarathons and Impact of Phased Electromagnetic Field Therapy (PEMF)
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.
- Conditions
- Healthy
- Being tested
- Pulsed Electromagnetic Field therapy (PEMF), Pulsed Electromagnetic Field Sham therapy
- Keywords
- Ultramarathons, Electromagnetic field therapy, Endurance, Exercise, Environmental conditions
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Electromagnetic Field therapy (PEMF)Procedure or surgery
Also called Bioboosti
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).
Pulsed Electromagnetic Field Sham therapyProcedure or surgery
Also called Bioboosti Sham
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).
| Study group | Role | What they receive |
|---|---|---|
| HK100 Pulsed Electromagnetic Field | Experimental | 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. Receives: Procedure: Pulsed Electromagnetic Field therapy (PEMF) |
| HK100 Pulsed Electromagnetic Field Sham | Sham comparator | 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. Receives: Procedure: Pulsed Electromagnetic Field Sham therapy |
| UTMB Pulsed Electromagnetic Field | Experimental | 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. Receives: Procedure: Pulsed Electromagnetic Field therapy (PEMF) |
| UTMB Pulsed Electromagnetic Field Sham | Sham comparator | 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. Receives: Procedure: Pulsed Electromagnetic Field Sham therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: baseline, within 2 hours of race completion, 24-48 hours post race
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.
Measured: baseline, within 2 hours of race completion, 24-48 hours post race
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.
Measured: baseline, within 2 hours of race completion, 24-48 hours post race
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.
Measured: baseline, within 2 hours of race completion, 24-48 hours post race
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.
Measured: baseline, within 2 hours of race completion, 24-48 hours post race
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.
Measured: baseline, within 2 hours of race completion, 24-48 hours post race
Secondary outcomes (6)
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.
Measured: baseline, within 2 hours of race completion, 24-48 hours post race
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.
Measured: baseline, within 2 hours of race completion, 24-48 hours post race
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.
Measured: baseline, within 2 hours of race completion, 24-48 hours post race
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
Measured: baseline, within 2 hours of race completion, 24-48 hours post race
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
Measured: baseline, within 2 hours of race completion, 24-48 hours post race
Change in cortisol
Saliva levels of cortisol will be measured as a metric of stress. Cortisol levels increase when you body is under stress.
Measured: baseline, within 2 hours of race completion, 24-48 hours post race
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start12 Dec 2016
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruce Johnson, Mayo Clinic
- Investigators
- Bruce D Johnson, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03333135
- Sponsor's protocol ID
- 17-003843
- Status last verified
- Apr 2022
- First submitted
- 27 Oct 2017
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pulmonary Consequences of Participating in the UTMB and Hong Kong 100 Ultramarathons and Impact of Phased Electromagnetic Field Therapy (PEMF)
- ClinicalTrials.gov ID
- NCT03333135
- Acronym / sponsor ID
- 17-003843
- Conditions
- Healthy
- Keywords
- Ultramarathons, Electromagnetic field therapy, Endurance, Exercise, Environmental conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HK100 Pulsed Electromagnetic Field | Experimental | Procedure: 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. |
| HK100 Pulsed Electromagnetic Field Sham | Sham comparator | Procedure: Pulsed Electromagnetic Field Sham therapy20 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 | Experimental | Procedure: 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. |
| UTMB Pulsed Electromagnetic Field Sham | Sham comparator | Procedure: Pulsed Electromagnetic Field Sham therapy20 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy endurance trained individuals participating in the Ultra Trail du Mont Blanc (UTMB) and/or Hong Kong 100 ultramarathons
Key exclusion criteria (1 listed)
- > 65 years age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed Electromagnetic Field therapy (PEMF)Also: BioboostiPEMF 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). | Procedure or surgery | HK100 Pulsed Electromagnetic Field, UTMB Pulsed Electromagnetic Field |
| Pulsed Electromagnetic Field Sham therapyAlso: Bioboosti ShamPEMF 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). | Procedure or surgery | HK100 Pulsed Electromagnetic Field Sham, UTMB Pulsed Electromagnetic Field Sham |
Primary outcome
Change in right ventricle end diastolic area (EDA)
Time frame: 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 tricuspid annular plane systolic excursion (TAPSE)
Time frame: 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 ratio between early mitral inflow velocity and mitral annular early diastolic velocity (E/e')
Time frame: 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 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)
Time frame: 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 lung fluid assessed through ultrasound incidence of comet tails
Time frame: 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 lung fluid assessed through diffusion capacity of the lungs for carbon monoxide and nitric oxide
Time frame: 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.
6 secondary outcomes
Change in exhaled nitric oxide
Time frame: baseline, within 2 hours of race completion, 24-48 hours post race
Change in hemoglobin
Time frame: baseline, within 2 hours of race completion, 24-48 hours post race
Change in hematocrit
Time frame: baseline, within 2 hours of race completion, 24-48 hours post race
Change in cardiac troponin I
Time frame: baseline, within 2 hours of race completion, 24-48 hours post race
Change in B-type natriuretic peptide
Time frame: baseline, within 2 hours of race completion, 24-48 hours post race
Change in cortisol
Time frame: baseline, within 2 hours of race completion, 24-48 hours post race
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruce D Johnson principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Electromagnetic Field therapy (PEMF) in people with Healthy, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in right ventricle end diastolic area (EDA) (time frame: baseline, within 2 hours of race completion, 24-48 hours post race). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.