Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446466
Status:
COMPLETED
Last Update Posted:
2024-06-07
First Post:
2024-05-03
Brief Title:
PEMF Stimulation on Physical Exercise in Sedentary People
Sponsor:
University of Bologna
Organization:
University of Bologna
Study Overview
Official Title:
Influence of Pulsed Electromagnetic Fields PEMFs Stimulation on Physical Exercise in Sedentary People
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The pulsed electromagnetic fields PEMF are a non-invasive therapy used for clinical treatments Recent publications in exercise physiology showed that PEMF enhanced the velocity and the quantity of available muscle O2 and the rate of muscle oxygen extraction and utilization in semi-professional cyclists during a heavy constant-load exercise This study investigates the effect of stimulation on muscular activation in sedentary young people who perform a constant-load exercise at moderate intensity The protocols foresees the enrollment of nine male sedentary young people The response of the muscle activity will be recorded by surface electromyography EMG and assessed by measuring the root mean square normalized to the peak of the maximum voluntary contraction Data will be collected in the vastus Medialis RVM and Biceps Femoris RBF of the right leg at the baseline standstill sitting on warm-up unloaded cy-cling and during 30 minutes of constant-load exercise in two experimental conditions PEMF ON vs PEMF OFF
Detailed Description:
The study design is single-blind with randomized controlled condition Nine male sedentary young people will participate at this study Gpower software version 3192 Kiel Germany predicted that a total sample size of 8 would give sufficient power 080 to detect a significant difference at alpha level of 005 One additional participant will be included to ensure the availability of data in case of missing or corrupted data All participants will be volunteers healthy non-smokers without muscular injury or physical deficit at the time of the experiment Exclusion criteria are the use of supplements or medications All participants will receive both a written and verbal explanation of the experimental procedure The informed consent will be obtained before the beginning of recordings
The experiments will be performed on the cycle-ergometer H-300-R Lode Exere Air Machine Italy under a standardized procedure in a quiet room with a temperature of 22C Recordings will be performed at the same time of the day 900-1200 AM to avoid circadian influence Subjects will be instructed to avoid caffeine alcohol and heavy physical activity in the 12h preceding the experiment The surface EMG activity will be recorded from the right Vastus Medialis and right Biceps Femoris caput longum at a sampling rate of 1000 Hz by a Free-EMG 1000 BTS Bioengineering Inc Free-EMG is a device with wireless miniaturized probes for the dynamic analysis of muscle activity For signal acquisition the probes 415248x14mm are directly attached to the electrodes and signals are detected and captured Each probe is equipped with internal memory to ensure uninterrupted recording in case of temporary connection loss To stimulate the entire right thigh 2 circular 20 cm PEMF loop-antenna devices Torino II Rio Grande Neurosciences USA will be placed at the beginning and at the end of the right leg The PEMF waveform consists of a pulse-burst modulated 2712 Mega-Hertz MHz sinusoidal carrier with 2ms burst width repeated at 2 Hertz with peak magnetic field at the center of the loop 51 microTesla
Participants will come to the laboratory 5 times with an interval of 3 days between each time In each of these visits few recordings will be performed
The first day foresees the recording of the maximum voluntary contraction MVC and an incremental test until exhaustion to find the individual maximum oxygen consumption VO2max Regarding MVC recording each participant will perform for five seconds an isometric contraction against a maximum load using isotonic machines Exere Air Machine Italy The participants will repeat the same procedure 3 times separated by 2 minutes of rest The MVC peak value of each investigated muscle will be used to normalize electromyographic data procedure already used in previous studies Regarding VO2max recording each subject will perform an incremental test on a cycle-ergometer H-300-R Lode to find the maximum oxygen consumption VO2max in order to individualize the correct workload to be used for the exercise sessions Gases will be analyzed using a Quark b2 breath-by-breath metabolic system Cosmed Italy The system will be calibrated immediately before each test in accordance with the manufacturers guidelines volume calibration will be performed at different flow rates with a 3- L calibration syringe and calibration of gas analyzers will be performed with a tank of reference gas mixture 1600 O2 500 CO2 and ambient air 2093 O2 and 003 CO2
From day two to four participants will come to the laboratory for the exercise sessions The experimental conditions will be PEMF ON and PEMF OFF in which the PEMF will be turned on and off respectively When the trial will start with the PEMF in ON modality the device will be turned off after 17 minutes and the participant will keep going cycling until the end of the trial Otherwise when the trial will start with the PEMF in OFF modality the device will be turned on after 17 minutes and the participant will keep going cycling until the end of the trial Each condition will be repeated twice in different days for a total of four recordings per subject The two PEMF loops will be positioned on the right leg in both experimental conditions in order to avoid stimulation being perceived by the subjects at the skin level
Data will be recorded in three epochs 1 baseline 2 warm-up 3 constant-load exercise To record the baseline values the participants will sit for 1-minute with the right leg extended The warm-up involves an unloaded cycling for 1-minute Then an instantaneous increase of the workload which will be attained in 3s will be the onset for the constant-load exercise physical effort Participants will be instructed to keep cycling at a cadence of 70 revolutions per minute for the entire duration of the trial Each trial will be ended after 30 minutes of exercise
The experiments will be performed on the cycle-ergometer H-300-R Lode Exere Air Machine Italy under a standardized procedure in a quiet room with a temperature of 22C Recordings will be performed at the same time of the day 900-1200 AM to avoid circadian influence Subjects will be instructed to avoid caffeine alcohol and heavy physical activity in the 12h preceding the experiment The surface EMG activity will be recorded from the right Vastus Medialis and right Biceps Femoris caput longum at a sampling rate of 1000 Hz by a Free-EMG 1000 BTS Bioengineering Inc Free-EMG is a device with wireless miniaturized probes for the dynamic analysis of muscle activity For signal acquisition the probes 415248x14mm are directly attached to the electrodes and signals are detected and captured Each probe is equipped with internal memory to ensure uninterrupted recording in case of temporary connection loss To stimulate the entire right thigh 2 circular 20 cm PEMF loop-antenna devices Torino II Rio Grande Neurosciences USA will be placed at the beginning and at the end of the right leg The PEMF waveform consists of a pulse-burst modulated 2712 Mega-Hertz MHz sinusoidal carrier with 2ms burst width repeated at 2 Hertz with peak magnetic field at the center of the loop 51 microTesla
Participants will come to the laboratory 5 times with an interval of 3 days between each time In each of these visits few recordings will be performed
The first day foresees the recording of the maximum voluntary contraction MVC and an incremental test until exhaustion to find the individual maximum oxygen consumption VO2max Regarding MVC recording each participant will perform for five seconds an isometric contraction against a maximum load using isotonic machines Exere Air Machine Italy The participants will repeat the same procedure 3 times separated by 2 minutes of rest The MVC peak value of each investigated muscle will be used to normalize electromyographic data procedure already used in previous studies Regarding VO2max recording each subject will perform an incremental test on a cycle-ergometer H-300-R Lode to find the maximum oxygen consumption VO2max in order to individualize the correct workload to be used for the exercise sessions Gases will be analyzed using a Quark b2 breath-by-breath metabolic system Cosmed Italy The system will be calibrated immediately before each test in accordance with the manufacturers guidelines volume calibration will be performed at different flow rates with a 3- L calibration syringe and calibration of gas analyzers will be performed with a tank of reference gas mixture 1600 O2 500 CO2 and ambient air 2093 O2 and 003 CO2
From day two to four participants will come to the laboratory for the exercise sessions The experimental conditions will be PEMF ON and PEMF OFF in which the PEMF will be turned on and off respectively When the trial will start with the PEMF in ON modality the device will be turned off after 17 minutes and the participant will keep going cycling until the end of the trial Otherwise when the trial will start with the PEMF in OFF modality the device will be turned on after 17 minutes and the participant will keep going cycling until the end of the trial Each condition will be repeated twice in different days for a total of four recordings per subject The two PEMF loops will be positioned on the right leg in both experimental conditions in order to avoid stimulation being perceived by the subjects at the skin level
Data will be recorded in three epochs 1 baseline 2 warm-up 3 constant-load exercise To record the baseline values the participants will sit for 1-minute with the right leg extended The warm-up involves an unloaded cycling for 1-minute Then an instantaneous increase of the workload which will be attained in 3s will be the onset for the constant-load exercise physical effort Participants will be instructed to keep cycling at a cadence of 70 revolutions per minute for the entire duration of the trial Each trial will be ended after 30 minutes of exercise
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None