Skeletal Muscle PerformanceNCT04934709
Photobiomodulation Therapy Combined With Static Magnetic Field on the Subsequent Performance
A study testing Active PBMT-sMF in people with Skeletal Muscle Performance, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
There is evidence about the effects of photobiomodulation therapy (PBMT) alone and combined with static magnetic field (PBMT-sMF) on skeletal muscle fatigue, physical performance and post-exercise recovery in different types of exercise protocols and sports activity. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Skeletal Muscle Performance
- What is being tested?
- Active PBMT-sMF
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- May 2015to Sep 2015
- 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 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male healthy volunteers;
- Non-athletes or those who practiced physical activity up to once a week;
- Aged 18-35 years.
Who cannot join
- History of musculoskeletal injuries in the hip and knee regions in the two months prior to the study;
- Use of pharmacological agents and nutritional supplements;
- Chronic joint disease in the non-dominant lower limb.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Laboratory of Phototherapy and Innovative Technologies in Health
São Paulo
About this study
Official title: Immediate Effects of Photobiomodulation Therapy Combined With Static Magnetic Field on the Subsequent Performance: a Randomized Crossover Triple-blinded Placebo-controlled Trial
There is evidence about the effects of photobiomodulation therapy (PBMT) alone and combined with static magnetic field (PBMT-sMF) on skeletal muscle fatigue, physical performance and post-exercise recovery in different types of exercise protocols and sports activity. However, it is unknown the effects of PBMT-sMF to improve the subsequent performance after a first set of exercise. Therefore, the aim of this study was to investigate the effects of PBMT-sMF, applied between two sets of exercises, on the subsequent physical performance.
Read the detailed description
A randomized, crossover, triple-blinded (assessors, therapist and volunteers), placebo-controlled trial was carried out. Healthy non-athletes' male volunteers were randomized and treated with a single application of PBMT-sMF and placebo between two sets of an exercise protocol performed on isokinetic dynamometer.
The order of interventions was randomized.
The primary outcome was fatigue index, measured by isokinetic dynamometer during the exercise protocol. The secondary outcomes were total work and peak torque measured by isokinetic dynamometer during the exercise protocol; and blood lactate, measured by blood samples collected before, 3 minutes after the first set of the exercise protocol, 3 minutes after the application of the intervention and 3 minutes after the second set of the exercise protocol.
Statistical analysis:
The findings were tested for normality using the Kolmogorov-Smirnov test and were determined to have a normal distribution. Data were expressed as the mean and standard deviation, and a two-way repeated measures ANOVA was performed to test between-group differences at each timepoint (treatment effects), mean difference (MD) and 95% confidence intervals (CI), followed by the Bonferroni post hoc test. The significance level was set at p < 0.05.
- Conditions
- Skeletal Muscle Performance
- Being tested
- Active PBMT-sMF, Placebo PBMT-sMF
- Keywords
- Photobiomodulation Therapy, Static Magnetic Field, Subsequent performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active PBMT-sMFDevice
PBMT-sMF was applied employing the Multi Radiance Medical Super Pulsed Laser MR4 console (Solon, Ohio, USA) with a LaserShower cluster probe as emitter. Six different sites of the knee extensor muscles (two medial, two lateral and two central points) were irradiated at the same time.
Placebo PBMT-sMFDevice
Placebo PBMT-sMF was applied employing the Multi Radiance Medical Super Pulsed Laser MR4 console (Solon, Ohio, USA) with a LaserShower cluster probe as emitter, but without any emission of therapeutic dose. Placebo PBMT-sMF was applied at six different sites of the knee extensor muscles (two medial, two lateral and two central points).
| Study group | Role | What they receive |
|---|---|---|
| PBMT-sMF | Experimental | Volunteers underwent intervention (active PBMT-sMF) in the non-dominant lower limb. A single application was performed at each phase of the trial, between the first and second set of the exercise protocol. Receives: Device: Active PBMT-sMF |
| Placebo | Placebo comparator | Volunteers underwent intervention (placebo PBMT-sMF) in the non-dominant lower limb. A single application was performed at each phase of the trial, between the first and second set of the exercise protocol. Receives: Device: Placebo PBMT-sMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue index
Variable provided directly by the isokinetic dynamometer during the exercise protocol.
Measured: 1 minute after the end of exercise protocol.
Secondary outcomes (3)
Total work
Variable provided directly by the isokinetic dynamometer during the exercise protocol.
Measured: 1 minute after the end of exercise protocol.
Peak torque
Variable provided directly by the isokinetic dynamometer during the exercise protocol.
Measured: 1 minute after the end of exercise protocol.
Blood lactate
Measured by blood samples.
Measured: 3 minutes after the first set of the exercise protocol, 3 minutes after the application of the intervention and 3 minutes after the second set of the exercise protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study startMay 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal Muscle PerformanceStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ernesto Cesar Pinto Leal Junior, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934709
- Sponsor's protocol ID
- 665332
- Status last verified
- Jun 2021
- First submitted
- 10 Jun 2021
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data will be shared upon request addressed to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of Photobiomodulation Therapy Combined With Static Magnetic Field on the Subsequent Performance: a Randomized Crossover Triple-blinded Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04934709
- Acronym / sponsor ID
- 665332
- Conditions
- Skeletal Muscle Performance
- Keywords
- Photobiomodulation Therapy, Static Magnetic Field, Subsequent performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 22 Jun 2021 (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.
There is evidence about the effects of photobiomodulation therapy (PBMT) alone and combined with static magnetic field (PBMT-sMF) on skeletal muscle fatigue, physical performance and post-exercise recovery in different types of exercise protocols and sports activity. However, it is unknown the effects of PBMT-sMF to improve the subsequent performance after a first set of exercise. Therefore, the aim of this study was to investigate the effects of PBMT-sMF, applied between two sets of exercises, on the subsequent physical performance.
Detailed description
A randomized, crossover, triple-blinded (assessors, therapist and volunteers), placebo-controlled trial was carried out. Healthy non-athletes' male volunteers were randomized and treated with a single application of PBMT-sMF and placebo between two sets of an exercise protocol performed on isokinetic dynamometer.
The order of interventions was randomized.
The primary outcome was fatigue index, measured by isokinetic dynamometer during the exercise protocol. The secondary outcomes were total work and peak torque measured by isokinetic dynamometer during the exercise protocol; and blood lactate, measured by blood samples collected before, 3 minutes after the first set of the exercise protocol, 3 minutes after the application of the intervention and 3 minutes after the second set of the exercise protocol.
Statistical analysis:
The findings were tested for normality using the Kolmogorov-Smirnov test and were determined to have a normal distribution. Data were expressed as the mean and standard deviation, and a two-way repeated measures ANOVA was performed to test between-group differences at each timepoint (treatment effects), mean difference (MD) and 95% confidence intervals (CI), followed by the Bonferroni post hoc test. The significance level was set at p < 0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PBMT-sMF | Experimental | Device: Active PBMT-sMFVolunteers underwent intervention (active PBMT-sMF) in the non-dominant lower limb. A single application was performed at each phase of the trial, between the first and second set of the exercise protocol. |
| Placebo | Placebo comparator | Device: Placebo PBMT-sMFVolunteers underwent intervention (placebo PBMT-sMF) in the non-dominant lower limb. A single application was performed at each phase of the trial, between the first and second set of the exercise protocol. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male healthy volunteers;
- Non-athletes or those who practiced physical activity up to once a week;
- Aged 18-35 years.
Key exclusion criteria (3 listed)
- History of musculoskeletal injuries in the hip and knee regions in the two months prior to the study;
- Use of pharmacological agents and nutritional supplements;
- Chronic joint disease in the non-dominant lower limb.
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 |
|---|---|---|
| Active PBMT-sMFPBMT-sMF was applied employing the Multi Radiance Medical Super Pulsed Laser MR4 console (Solon, Ohio, USA) with a LaserShower cluster probe as emitter. Six different sites of the knee extensor muscles (two medial, two lateral and two central points) were irradiated at the same time. | Device | PBMT-sMF |
| Placebo PBMT-sMFPlacebo PBMT-sMF was applied employing the Multi Radiance Medical Super Pulsed Laser MR4 console (Solon, Ohio, USA) with a LaserShower cluster probe as emitter, but without any emission of therapeutic dose. Placebo PBMT-sMF was applied at six different sites of the knee extensor muscles (two medial, two lateral and two central points). | Device | Placebo |
Primary outcome
Fatigue index
Time frame: 1 minute after the end of exercise protocol.
Variable provided directly by the isokinetic dynamometer during the exercise protocol.
3 secondary outcomes
Total work
Time frame: 1 minute after the end of exercise protocol.
Peak torque
Time frame: 1 minute after the end of exercise protocol.
Blood lactate
Time frame: 3 minutes after the first set of the exercise protocol, 3 minutes after the application of the intervention and 3 minutes after the second set of the exercise protocol.
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 22 Jun 2021.
- Individual participant dataSharing planned: Yes. Data will be shared upon request addressed to the principal investigator.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active PBMT-sMF in people with Skeletal Muscle Performance, run by University of Nove de Julho at 1 site in Brazil.
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 3 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 22 Jun 2021. 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 Brazil. 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?
Fatigue index (time frame: 1 minute after the end of exercise protocol.). 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 22 Jun 2021.