Ultramarathons and Impact of Phased Electromagnetic Field Therapy (PEMF)

NCT03333135 | Completed

• 1 other identifier: 17-003843
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Ultramarathons; Electromagnetic field therapy; Endurance; Exercise; Environmental conditions

Outcome Measures

Primary Outcomes (6)

• 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 .

  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.

  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.

  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.

  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.

  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.

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

Secondary Outcomes (6)

• Change in exhaled nitric oxide

  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 B-type natriuretic peptide

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

Study Arms (4)

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.

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.

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.

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.

Procedure: Pulsed Electromagnetic Field Sham therapy

Interventions

Pulsed Electromagnetic Field therapy (PEMF) PROCEDURE

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

HK100 Pulsed Electromagnetic Field; UTMB Pulsed Electromagnetic Field

Pulsed Electromagnetic Field Sham therapy PROCEDURE

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

HK100 Pulsed Electromagnetic Field Sham; UTMB Pulsed Electromagnetic Field Sham

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \> 65 years age

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Bruce D Johnson

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Study team and participants will not know if they have received the PEMF therapy or the sham
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 27, 2017
• First Posted: November 6, 2017
• Study Start: December 12, 2016
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: April 11, 2022

Record last verified: 2022-04

Locations

US (1)