PEMF EffectNCT06446466
PEMF Stimulation on Physical Exercise in Sedentary People
A study testing PEMF ON-OFF and PEMF OFF-ON in people with PEMF Effect, run by University of Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 23 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- PEMF Effect
- What is being tested?
- PEMF ON-OFF and PEMF OFF-ON
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteItaly
- Study dates
- 12 Nov 2023to 3 Feb 2024
- 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 23 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy sedentary volunteers
Who cannot join
- smokers
- muscular injury or physical deficit at the time of the experiment
- use of supplements or medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Pulsed Electromagnetic Fields (PEMFs) Stimulation on Physical Exercise in Sedentary People
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).
Read the detailed description
The study design is single-blind with randomized controlled condition. Nine male sedentary young people will participate at this study. G∗power software version 3.1.9.2 (Kiel, Germany) predicted that a total sample size of 8 would give sufficient power (0.80) to detect a significant difference at alpha level of 0.05. 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 22°C. Recordings will be performed at the same time of the day (9:00-12:00 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 (41,5×24,8x14mm) 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 27.12 Mega-Hertz (MHz) sinusoidal carrier, with 2ms burst width repeated at 2 Hertz, with peak magnetic field at the center of the loop 5±1 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 manufacturer's 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 (16.00% O2, 5.00% CO2) and ambient air (20.93% O2 and 0.03% 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.
- Conditions
- PEMF Effect
- Being tested
- PEMF ON-OFF, PEMF OFF-ON
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEMF ON-OFFDevice
In the experimental condition PEMF ON-OFF, the participants will start the exercise session with PEMF in ON modality. The PEMF device will be kept ON for 17 minutes. Then, it will be turned OFF while the participant will keep going cycling until the end of the trial.
This condition is used to investigate the effect on PEMF at the onset of the exercise. Data acquired in the first 17 minutes (PEMF ON) will be compared with those recorded in the last 17 minutes (PEMF OFF) of the exercise session.
PEMF OFF-ONDevice
In the experimental condition PEMF OFF-ON, the participants will start the exercise session with PEMF in OFF modality. The PEMF device will be kept OFF for 17 minutes. Then, it will be turned ON and the participant will keep going cycling until the end of the trial.
This condition is used to investigate the effect of PEMF during the exercise, when the muscle will have worked for 17 minutes. Data acquired in the first 17 minutes (PEMF OFF) will be compared with those recorded in the last 17 minutes (PEMF ON) of the exercise session.
| Study group | Role | What they receive |
|---|---|---|
| Participants group | Experimental | Two interventions will be performed on the same group of subjects. Participants will be healthy volunteers with sedentary habits.
The experiments will be performed on the cycle-ergometer (H-300-R Lode, Exere Air Machine, Italy). 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.). 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 27.12 Mega-Hertz (MHz) sinusoidal carrier, with 2ms burst width repeated at 2 Hertz, with peak magnetic field at the center of the loop 5±1 microTesla. Receives: Device: PEMF ON-OFF; Device: PEMF OFF-ON |
What is being measured
The primary outcome is the main question the study is designed to answer.
PEMF effect on amplitude of muscle contraction
The aim is to verify if PEMF stimulation can enhance muscle activity during cycling. Electromyographic recordings on both vastus Medialis (RVM) and Biceps Femoris (RBF) of the right leg will be performed. To verify the effect, the amplitude (in mV) of the muscle response will be analyzed.
Measured: Two weeks recordings
PEMF effect on duration of muscle contraction
The aim is to verify if PEMF stimulation can enhance muscle activity during cycling. Electromyographic recordings on both vastus Medialis (RVM) and Biceps Femoris (RBF) of the right leg will be performed. To verify the effect, the duration (in msec) of the muscle response will by analyzed.
Measured: Two weeks recordings
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start12 Nov 2023
- Primary completion9 Jan 2024
- Study completion3 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PEMF EffectStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Milena Raffi, University of Bologna
- Investigators
- Milena Raffi, PhD, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446466
- Sponsor's protocol ID
- PEMF on sedentary
- Status last verified
- Jun 2024
- First submitted
- 3 May 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Trofe A, Piras A, Muehsam D, Meoni A, Campa F, Toselli S, Raffi M. Effect of Pulsed Electromagnetic Fields (PEMFs) on Muscular Activation during Cycling: A Single-Blind Controlled Pilot Study. Healthcare (Basel). 2023 Mar 22;11(6):922. doi: 10.3390/healthcare11060922.
PubMed 36981580Raffi M, Piras A, Persiani M, Perazzolo M, Squatrito S. Angle of gaze and optic flow direction modulate body sway. J Electromyogr Kinesiol. 2017 Aug;35:61-68. doi: 10.1016/j.jelekin.2017.05.008. Epub 2017 May 31.
PubMed 28601564
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Pulsed Electromagnetic Fields (PEMFs) Stimulation on Physical Exercise in Sedentary People
- ClinicalTrials.gov ID
- NCT06446466
- Acronym / sponsor ID
- PEMF on sedentary
- Conditions
- PEMF Effect
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 12 Nov 2023 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 3 Feb 2024 (actual)
- First posted
- 6 Jun 2024 (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.
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. G∗power software version 3.1.9.2 (Kiel, Germany) predicted that a total sample size of 8 would give sufficient power (0.80) to detect a significant difference at alpha level of 0.05. 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 22°C. Recordings will be performed at the same time of the day (9:00-12:00 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 (41,5×24,8x14mm) 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 27.12 Mega-Hertz (MHz) sinusoidal carrier, with 2ms burst width repeated at 2 Hertz, with peak magnetic field at the center of the loop 5±1 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 manufacturer's 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 (16.00% O2, 5.00% CO2) and ambient air (20.93% O2 and 0.03% 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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants group | Experimental | Device: PEMF ON-OFF, Device: PEMF OFF-ONTwo interventions will be performed on the same group of subjects. Participants will be healthy volunteers with sedentary habits. The experiments will be performed on the cycle-ergometer (H-300-R Lode, Exere Air Machine, Italy). 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.). 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 27.12 Mega-Hertz (MHz) sinusoidal carrier, with 2ms burst width repeated at 2 Hertz, with peak magnetic field at the center of the loop 5±1 microTesla. |
Who may qualify
- Ages
- 23 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy sedentary volunteers
Key exclusion criteria (3 listed)
- smokers
- muscular injury or physical deficit at the time of the experiment
- use of supplements or medications
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 |
|---|---|---|
| PEMF ON-OFFIn the experimental condition PEMF ON-OFF, the participants will start the exercise session with PEMF in ON modality. The PEMF device will be kept ON for 17 minutes. Then, it will be turned OFF while the participant will keep going cycling until the end of the trial. This condition is used to investigate the effect on PEMF at the onset of the exercise. Data acquired in the first 17 minutes (PEMF ON) will be compared with those recorded in the last 17 minutes (PEMF OFF) of the exercise session. | Device | Participants group |
| PEMF OFF-ONIn the experimental condition PEMF OFF-ON, the participants will start the exercise session with PEMF in OFF modality. The PEMF device will be kept OFF for 17 minutes. Then, it will be turned ON and the participant will keep going cycling until the end of the trial. This condition is used to investigate the effect of PEMF during the exercise, when the muscle will have worked for 17 minutes. Data acquired in the first 17 minutes (PEMF OFF) will be compared with those recorded in the last 17 minutes (PEMF ON) of the exercise session. | Device | Participants group |
Primary outcome
PEMF effect on amplitude of muscle contraction
Time frame: Two weeks recordings
The aim is to verify if PEMF stimulation can enhance muscle activity during cycling. Electromyographic recordings on both vastus Medialis (RVM) and Biceps Femoris (RBF) of the right leg will be performed. To verify the effect, the amplitude (in mV) of the muscle response will be analyzed.
PEMF effect on duration of muscle contraction
Time frame: Two weeks recordings
The aim is to verify if PEMF stimulation can enhance muscle activity during cycling. Electromyographic recordings on both vastus Medialis (RVM) and Biceps Femoris (RBF) of the right leg will be performed. To verify the effect, the duration (in msec) of the muscle response will by analyzed.
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 7 Jun 2024.
- Background: PubMed 36981580Trofe A, Piras A, Muehsam D, Meoni A, Campa F, Toselli S, Raffi M. Effect of Pulsed Electromagnetic Fields (PEMFs) on Muscular Activation during Cycling: A Single-Blind Controlled Pilot Study. Healthcare (Basel). 2023 Mar 22;11(6):922. doi: 10.3390/healthcare11060922.
- Background: PubMed 28601564Raffi M, Piras A, Persiani M, Perazzolo M, Squatrito S. Angle of gaze and optic flow direction modulate body sway. J Electromyogr Kinesiol. 2017 Aug;35:61-68. doi: 10.1016/j.jelekin.2017.05.008. Epub 2017 May 31.
- Individual participant dataSharing planned: No
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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.
Milena Raffi, PhD principal investigator
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEMF ON-OFF and PEMF OFF-ON in people with PEMF Effect, run by University of Bologna at 1 site in Italy.
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 3 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 7 Jun 2024. 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 Italy. 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. 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?
PEMF effect on amplitude of muscle contraction (time frame: Two weeks recordings). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06446466, which also lists 2 linked publications.
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 7 Jun 2024.