Muscle Development in Association to PhototherapyNCT02474602
Phototherapy Applied in Association With Strength Training
A study of Muscle Development in Association to Phototherapy, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
The effects of phototherapy has been widely studied by some research groups. The investigators know that there are positive results with light application to improve muscle performance and delay fatigue. However, there are few studies showing its´ effects on muscular training. 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
- Muscle Development in Association to Phototherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- Jun 2014to Aug 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
- There were included in the study
- healthy individuals,
- active,
- aged between 18 and 35 years old,
- male,
- presenting no history of musculoskeletal injury in the regions of the hip and knee in the two months prior to the study.
- that are not making use of pharmacological agents and / or nutritional supplements, and
- that have at least 80% of attendance to training.
Who cannot join
- The participants were excluded if they
- present some musculoskeletal injury during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phototherapy Applied in Association of Muscle Training: Evaluation of Different Irradiation Protocols
The effects of phototherapy has been widely studied by some research groups. The investigators know that there are positive results with light application to improve muscle performance and delay fatigue. However, there are few studies showing its´ effects on muscular training. Therefore, the aim of this study was to assess the effects of phototherapy applied at different times during 12 weeks of strength training. For such, 48 volunteers, healthy male, from 18 to 35 years old were recruited to perform a strength training protocol for the anterior muscle of the thigh development. Volunteers performed the training protocol twice a week for 12 weeks. There were assessed isometric peak torque in isokinetic dynamometer, 1-repetition maximum test in the leg extension and leg press machines and bilateral thigh perimetry.
Read the detailed description
This is a clinical, randomized, controlled placebo and double-blind study. Forty-eight participants performed strength training protocol. Subjects practiced a protocol training with 80% of the load, measured through 1-repetition maximum test. The training protocol consisted in performing 5 sets of 10 repetitions, twice a week, employing leg extension and leg press machines.
Phototherapy, active or placebo, were applied in 6 different points of anterior muscle of the thigh before and after each training session. Only one investigator, that did not participate in any phase of the assessments and trainings sessions, knew about what program is active or placebo in phototherapy device. Randomisation carried out by a simple drawing of lots (A, B, C, or D) in the first visit. The phototherapy unit emitted the same sound regardless of the program used, active or placebo. Either strength training lasted 12 weeks and assessments were performed at baseline, 4, 8 and 12 weeks. There were evaluated maximal voluntary contraction (MVC), bilateral thigh perimetry and 1-repetition maximum test (1-RM).
- Being tested
- Active or Placebo Phototherapy (MR4)
- Keywords
- phototherapy, strength training, photobiostimulation, muscle development
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active or Placebo Phototherapy (MR4)Device
Also called MR4 device - device that combines super-pulsed lasers, and red and infrared LEDs (Multi Radiance Medical, Solon, OH, USA)
Participants performed a strength training. Forty-eight subjects practiced a training protocol with 80% of the load, measured through 1-repetition maximum test. The strength training lasted 12 weeks and the evaluations were done monthly. Phototherapy, active or placebo, were applied in 6 different points of quadriceps muscle depending the group randomized, before and after each training session.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Active or Placebo Phototherapy | Experimental | The phototherapy was divided in program 1 and program 2. One of these programs consisted in active phototherapy and the other placebo.
The subjects allocated in group A, received program 1 before strength training, and the same program 1 after training. Receives: Device: Active or Placebo Phototherapy (MR4) |
| Group B - Active or Placebo Phototherapy | Experimental | The phototherapy was divided in program 1 and program 2. One of these programs consisted in active phototherapy and the other placebo.
The subjects allocated in group B, received program 1 before strength training, and program 2 after training. Receives: Device: Active or Placebo Phototherapy (MR4) |
| Group C - Active or Placebo Phototherapy | Experimental | The phototherapy was divided in program 1 and program 2. One of these programs consisted in active phototherapy and the other placebo.
The subjects allocated in group C, received program 2 before strength training, and program 1 after training. Receives: Device: Active or Placebo Phototherapy (MR4) |
| Group D - Active or Placebo Phototherapy' | Experimental | The phototherapy was divided in program 1 and program 2. One of these programs consisted in active phototherapy and the other placebo.
The subjects allocated in group B, received program 2 before strength training, and the same program 2 after training. Receives: Device: Active or Placebo Phototherapy (MR4) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum voluntary contraction in the isokinetic dynamometer (MVC)
Functional performance measure
Measured: 12 weeks
Secondary outcomes (2)
1-Repetition Maximum test in the leg press and leg extension machines (1-RM)
Functional performance measure
Measured: 12 weeks
Thigh perimetry
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startJun 2014
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Muscle Development in Association to PhototherapyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Adriane Aver Vanin, University of Nove de Julho
- Investigators
- Ernesto Cesar P Leal Junior, PhD, Study director, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474602
- Sponsor's protocol ID
- Nove de Julho University
- Other IDs
- 2013/19355-3
- Status last verified
- Feb 2016
- First submitted
- 11 Jun 2015
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Leal-Junior EC, Vanin AA, Miranda EF, de Carvalho Pde T, Dal Corso S, Bjordal JM. Effect of phototherapy (low-level laser therapy and light-emitting diode therapy) on exercise performance and markers of exercise recovery: a systematic review with meta-analysis. Lasers Med Sci. 2015 Feb;30(2):925-39. doi: 10.1007/s10103-013-1465-4. Epub 2013 Nov 19.
PubMed 24249354Seynnes OR, de Boer M, Narici MV. Early skeletal muscle hypertrophy and architectural changes in response to high-intensity resistance training. J Appl Physiol (1985). 2007 Jan;102(1):368-73. doi: 10.1152/japplphysiol.00789.2006. Epub 2006 Oct 19.
PubMed 17053104Antonialli FC, De Marchi T, Tomazoni SS, Vanin AA, dos Santos Grandinetti V, de Paiva PR, Pinto HD, Miranda EF, de Tarso Camillo de Carvalho P, Leal-Junior EC. Phototherapy in skeletal muscle performance and recovery after exercise: effect of combination of super-pulsed laser and light-emitting diodes. Lasers Med Sci. 2014 Nov;29(6):1967-76. doi: 10.1007/s10103-014-1611-7. Epub 2014 Jun 19.
PubMed 24942380
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phototherapy Applied in Association of Muscle Training: Evaluation of Different Irradiation Protocols
- ClinicalTrials.gov ID
- NCT02474602
- Acronym / sponsor ID
- Nove de Julho University
- Keywords
- phototherapy, strength training, photobiostimulation, muscle development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jun 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 18 Jun 2015 (estimated)
- 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 effects of phototherapy has been widely studied by some research groups. The investigators know that there are positive results with light application to improve muscle performance and delay fatigue. However, there are few studies showing its´ effects on muscular training. Therefore, the aim of this study was to assess the effects of phototherapy applied at different times during 12 weeks of strength training. For such, 48 volunteers, healthy male, from 18 to 35 years old were recruited to perform a strength training protocol for the anterior muscle of the thigh development. Volunteers performed the training protocol twice a week for 12 weeks. There were assessed isometric peak torque in isokinetic dynamometer, 1-repetition maximum test in the leg extension and leg press machines and bilateral thigh perimetry.
Detailed description
This is a clinical, randomized, controlled placebo and double-blind study. Forty-eight participants performed strength training protocol. Subjects practiced a protocol training with 80% of the load, measured through 1-repetition maximum test. The training protocol consisted in performing 5 sets of 10 repetitions, twice a week, employing leg extension and leg press machines.
Phototherapy, active or placebo, were applied in 6 different points of anterior muscle of the thigh before and after each training session. Only one investigator, that did not participate in any phase of the assessments and trainings sessions, knew about what program is active or placebo in phototherapy device. Randomisation carried out by a simple drawing of lots (A, B, C, or D) in the first visit. The phototherapy unit emitted the same sound regardless of the program used, active or placebo. Either strength training lasted 12 weeks and assessments were performed at baseline, 4, 8 and 12 weeks. There were evaluated maximal voluntary contraction (MVC), bilateral thigh perimetry and 1-repetition maximum test (1-RM).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A - Active or Placebo Phototherapy | Experimental | Device: Active or Placebo Phototherapy (MR4)The phototherapy was divided in program 1 and program 2. One of these programs consisted in active phototherapy and the other placebo. The subjects allocated in group A, received program 1 before strength training, and the same program 1 after training. |
| Group B - Active or Placebo Phototherapy | Experimental | Device: Active or Placebo Phototherapy (MR4)The phototherapy was divided in program 1 and program 2. One of these programs consisted in active phototherapy and the other placebo. The subjects allocated in group B, received program 1 before strength training, and program 2 after training. |
| Group C - Active or Placebo Phototherapy | Experimental | Device: Active or Placebo Phototherapy (MR4)The phototherapy was divided in program 1 and program 2. One of these programs consisted in active phototherapy and the other placebo. The subjects allocated in group C, received program 2 before strength training, and program 1 after training. |
| Group D - Active or Placebo Phototherapy' | Experimental | Device: Active or Placebo Phototherapy (MR4)The phototherapy was divided in program 1 and program 2. One of these programs consisted in active phototherapy and the other placebo. The subjects allocated in group B, received program 2 before strength training, and the same program 2 after training. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- There were included in the study
- healthy individuals,
- active,
- aged between 18 and 35 years old,
- male,
Key exclusion criteria (2 listed)
- The participants were excluded if they
- present some musculoskeletal injury during the study
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 or Placebo Phototherapy (MR4)Also: MR4 device - device that combines super-pulsed lasers, and red and infrared LEDs (Multi Radiance Medical, Solon, OH, USA)Participants performed a strength training. Forty-eight subjects practiced a training protocol with 80% of the load, measured through 1-repetition maximum test. The strength training lasted 12 weeks and the evaluations were done monthly. Phototherapy, active or placebo, were applied in 6 different points of quadriceps muscle depending the group randomized, before and after each training session. | Device | Group A - Active or Placebo Phototherapy, Group B - Active or Placebo Phototherapy, Group C - Active or Placebo Phototherapy, Group D - Active or Placebo Phototherapy' |
Primary outcome
Maximum voluntary contraction in the isokinetic dynamometer (MVC)
Time frame: 12 weeks
Functional performance measure
2 secondary outcomes
1-Repetition Maximum test in the leg press and leg extension machines (1-RM)
Time frame: 12 weeks
Thigh perimetry
Time frame: 12 weeks
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 4 Feb 2016.
- Background: PubMed 24249354Leal-Junior EC, Vanin AA, Miranda EF, de Carvalho Pde T, Dal Corso S, Bjordal JM. Effect of phototherapy (low-level laser therapy and light-emitting diode therapy) on exercise performance and markers of exercise recovery: a systematic review with meta-analysis. Lasers Med Sci. 2015 Feb;30(2):925-39. doi: 10.1007/s10103-013-1465-4. Epub 2013 Nov 19.
- Results publication: PubMed 17053104Seynnes OR, de Boer M, Narici MV. Early skeletal muscle hypertrophy and architectural changes in response to high-intensity resistance training. J Appl Physiol (1985). 2007 Jan;102(1):368-73. doi: 10.1152/japplphysiol.00789.2006. Epub 2006 Oct 19.
- Results publication: PubMed 24942380Antonialli FC, De Marchi T, Tomazoni SS, Vanin AA, dos Santos Grandinetti V, de Paiva PR, Pinto HD, Miranda EF, de Tarso Camillo de Carvalho P, Leal-Junior EC. Phototherapy in skeletal muscle performance and recovery after exercise: effect of combination of super-pulsed laser and light-emitting diodes. Lasers Med Sci. 2014 Nov;29(6):1967-76. doi: 10.1007/s10103-014-1611-7. Epub 2014 Jun 19.
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.
Ernesto Cesar P Leal Junior, PhD study director
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Muscle Development in Association to Phototherapy, 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 8 inclusion and 2 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 4 Feb 2016. 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. 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?
Maximum voluntary contraction in the isokinetic dynamometer (MVC) (time frame: 12 weeks). 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 NCT02474602, which also lists 3 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 4 Feb 2016.