Muscle DevelopmentNCT03416998
Photobiomodulation On Muscle Recovery In Professional Soccer Players
A study testing phototherapy in people with Muscle Development, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
Background: Photobiomodulation with low-level laser therapy (LLLT) has been widely used in clinical practice for diverse purposes, such as modulation of the inflammatory process, acceleration of the tissue repair process, pain relief and the enhancement of post-exercise recovery. Read more about this study
- Who is it for?
- Ages 15 to 20 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Development
- What is being tested?
- phototherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Mar 2016to 10 Feb 2018
- 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 15 to 20 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy professional soccer players aged 15 to 20 years from the same team with a body mass index in the ideal range (20 to 25 kg/m2) will be included in the study.
Who cannot join
- A history of musculoskeletal injuries and/or surgeries in the lower limbs or back surgery in the previous six months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect Of Pre-Game Photobiomodulation On Muscle Recovery In Professional Soccer Players: Randomized, Cross-Over, Sham-Controlled, Triple-Blind, Clinical Trial
Background: Photobiomodulation with low-level laser therapy (LLLT) has been widely used in clinical practice for diverse purposes, such as modulation of the inflammatory process, acceleration of the tissue repair process, pain relief and the enhancement of post-exercise recovery. Studies have demonstrated a beneficial interaction between photobiomodulation and the production of creatine kinase, with a reduction in the release of this marker of muscle damage when laser and/or LEDs is administered prior to high-intensity physical activity. The aim of the proposed study is to determine the influence of pre-exercise phototherapy on post-exercise muscle recovery.
Methods: A randomized, cross-over, sham-controlled, double-blind, clinical trial is proposed. The participants will be healthy professional soccer players aged 15 to 20 years from the same team with a body mass index within the ideal range (20 to 25 kg/m2) and no history of lower limb musculoskeletal injuries or surgery or back surgery in the previous six months. The athletes will be allocated to two groups based on the previously calculated sample size and will be blinded to allocation. Creatine kinase will be measured and the subjective perception of fatigue will be determined for each participant. The volunteers will then be randomly allocated to Group A, which will receive active phototherapy, and Group B, which will receive sham phototherapy. The athletes will undergo reevaluations immediately after as well as 48 hours after a football match. The data will be submitted to statistical analysis and the level of significance will be set to 5%.
- Conditions
- Muscle Development
- Being tested
- phototherapy
- Keywords
- Photherapy, Photobiomodulation, Creatine Kinase, Soccer, Muscle Recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phototherapyOther
Phototherapy will be performed using clusters of 12 diodes (Table 1); four 905 nm diodes (mean power of 0.3125 mW and peak power of 12.5 W for each diode; 250 Hz), four 875 nm diodes (mean power of 17.5 mW for each diode) and four 640 nm diodes (mean power of 15 mW for each diode). The device manufactured by Multi Radiance Medical® (Solon, OH, USA) will be used due to its high quality, ample use in clinical practice and due to the fact that no national companies manufacture diode clusters with the characteristics required for the proposed project.
| Study group | Role | What they receive |
|---|---|---|
| Phototherapy Active | Active comparator | Phototherapy active group will be administered 30 minutes prior to the soccer match as well as 48 h after the match in direct contact with the skin with light pressure at predetermined sites: nine on the knee extensor muscles, six on the knee flexor muscles and two on the gastrocnemius muscle on both lower limbs. Receives: Other: phototherapy |
| Placebo Phototherapy | Placebo comparator | Phototherapy placebo group will be administered 30 minutes prior to the soccer match as well as 48 h after the match in direct contact with the skin with light pressure at predetermined sites: nine on the knee extensor muscles, six on the knee flexor muscles and two on the gastrocnemius muscle on both lower limbs.
For placebo treatment, the same procedures and treatment times will be employed, but the equipment will be set in placebo mode. Only the researcher in charge of programming the device will have knowledge regarding which treatment is being used. However, the programmer will not participate in the execution of the treatment, evaluations or data analysis Receives: Other: phototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle recovery
Analysis of creatine kinase
Measured: 30 Minutes
Secondary outcomes (1)
Subjective muscle recovery
Analysis of subjective fatigue scale
Measured: 30 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start3 Mar 2016
- Primary completion10 Nov 2017
- Study completion10 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle DevelopmentStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Ap. Biasotto-Gonzalez, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03416998
- Sponsor's protocol ID
- PHOTOBIOMODULATION
- Status last verified
- Feb 2022
- First submitted
- 26 Nov 2017
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Pre-Game Photobiomodulation On Muscle Recovery In Professional Soccer Players: Randomized, Cross-Over, Sham-Controlled, Triple-Blind, Clinical Trial
- ClinicalTrials.gov ID
- NCT03416998
- Acronym / sponsor ID
- PHOTOBIOMODULATION
- Conditions
- Muscle Development
- Keywords
- Photherapy, Photobiomodulation, Creatine Kinase, Soccer, Muscle Recovery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 3 Mar 2016 (actual)
- Primary completion
- 10 Nov 2017 (actual)
- Study completion
- 10 Feb 2018 (actual)
- First posted
- 31 Jan 2018 (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.
Background: Photobiomodulation with low-level laser therapy (LLLT) has been widely used in clinical practice for diverse purposes, such as modulation of the inflammatory process, acceleration of the tissue repair process, pain relief and the enhancement of post-exercise recovery. Studies have demonstrated a beneficial interaction between photobiomodulation and the production of creatine kinase, with a reduction in the release of this marker of muscle damage when laser and/or LEDs is administered prior to high-intensity physical activity. The aim of the proposed study is to determine the influence of pre-exercise phototherapy on post-exercise muscle recovery.
Methods: A randomized, cross-over, sham-controlled, double-blind, clinical trial is proposed. The participants will be healthy professional soccer players aged 15 to 20 years from the same team with a body mass index within the ideal range (20 to 25 kg/m2) and no history of lower limb musculoskeletal injuries or surgery or back surgery in the previous six months. The athletes will be allocated to two groups based on the previously calculated sample size and will be blinded to allocation. Creatine kinase will be measured and the subjective perception of fatigue will be determined for each participant. The volunteers will then be randomly allocated to Group A, which will receive active phototherapy, and Group B, which will receive sham phototherapy. The athletes will undergo reevaluations immediately after as well as 48 hours after a football match. The data will be submitted to statistical analysis and the level of significance will be set to 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phototherapy Active | Active comparator | Other: phototherapyPhototherapy active group will be administered 30 minutes prior to the soccer match as well as 48 h after the match in direct contact with the skin with light pressure at predetermined sites: nine on the knee extensor muscles, six on the knee flexor muscles and two on the gastrocnemius muscle on both lower limbs. |
| Placebo Phototherapy | Placebo comparator | Other: phototherapyPhototherapy placebo group will be administered 30 minutes prior to the soccer match as well as 48 h after the match in direct contact with the skin with light pressure at predetermined sites: nine on the knee extensor muscles, six on the knee flexor muscles and two on the gastrocnemius muscle on both lower limbs. For placebo treatment, the same procedures and treatment times will be employed, but the equipment will be set in placebo mode. Only the researcher in charge of programming the device will have knowledge regarding which treatment is being used. However, the programmer will not participate in the execution of the treatment, evaluations or data analysis |
Who may qualify
- Ages
- 15 to 20 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Healthy professional soccer players aged 15 to 20 years from the same team with a body mass index in the ideal range (20 to 25 kg/m2) will be included in the study.
Key exclusion criteria (1 listed)
- A history of musculoskeletal injuries and/or surgeries in the lower limbs or back surgery in the previous six months
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 |
|---|---|---|
| phototherapyPhototherapy will be performed using clusters of 12 diodes (Table 1); four 905 nm diodes (mean power of 0.3125 mW and peak power of 12.5 W for each diode; 250 Hz), four 875 nm diodes (mean power of 17.5 mW for each diode) and four 640 nm diodes (mean power of 15 mW for each diode). The device manufactured by Multi Radiance Medical® (Solon, OH, USA) will be used due to its high quality, ample use in clinical practice and due to the fact that no national companies manufacture diode clusters with the characteristics required for the proposed project. | Other | Phototherapy Active, Placebo Phototherapy |
Primary outcome
Muscle recovery
Time frame: 30 Minutes
Analysis of creatine kinase
1 secondary outcome
Subjective muscle recovery
Time frame: 30 Minutes
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 21 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Muscle Development
Recruiting
Development of a Real-time Controller to Estimate Walking Performance Using a Bilateral Ankle Exoskeleton
Healthy Young Adults
Recruiting
Development of Magnetic Resonance Spectroscopic Imaging Techniques for Imaging Metabolites in Human Brain and Muscle
Brain Mapping, Healthy Volunteer
RecruitingObservational study
Study of the Disease Process of Lymphangioleiomyomatosis
Lung Disease, Pneumothorax
RecruitingEarly Phase 1
Aprepitant for the Treatment of CLIFAHDD
CLIFAHDD, Congenital Contractures of the Limbs and Face, Hypotonia, and Developmental Delay
RecruitingPhase 3
A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)
Metastatic Castration Resistant Prostate Cancer
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 phototherapy in people with Muscle Development, 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 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 21 Feb 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 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?
Muscle recovery (time frame: 30 Minutes). 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 21 Feb 2022.