Muscle AdaptationNCT02715050
Phototherapy Applied in Association With Muscular Training
A study of Muscle Adaptation, 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 Adaptation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2016to Oct 2016
- Phase
- Interventional
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
- healthy individuals,
- active, that performed less than two exercise sessions per week
- when they presented musculoskeletal injury to the hips or knees in the previous 2 months,
- used pharmacological agents or nutritional supplements regularly, and
- Subjects that did not attend a minimum rate of 80% of all strength training sessions
- Suffered musculoskeletal injury during the ongoing of the study were also excluded.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phototherapy Applied in Association With Muscular Training: Evaluation of Different Moments of Applications
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 three times a week for 12 weeks. There were assessed isometric peak torque in isokinetic dynamometer, concentric peak torque, 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 muscular training protocol. Subjects practiced a protocol training with 60% of the load followed by 80% of the load, measured through 1-repetition maximum test, in all sessions of the training protocol. The training protocol consisted in performing 3 sets of 7 repetitions with 60% of 1-RM, and 4 set of 7 repetitions with 80% of 1-RM. This protocol was performed in every sessions, three times a week, employing leg press and leg extension 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), concentric torque, bilateral thigh perimetry and 1-repetition maximum test (1-RM).
- Conditions
- Muscle Adaptation
- Being tested
- Active or Placebo Phototherapy (MR4)
- Keywords
- phototherapy, photobiostimulation, muscle training, muscular adaptation
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)
| Study group | Role | What they receive |
|---|---|---|
| Group A - Active or Placebo Phototherapy | Experimental | Participants enrolled in this group performed a training protocol for 12 weeks with light application before and after the exercise protocol. The phototherapy device 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 | Participants enrolled in this group performed a training protocol for 12 weeks with light application before and after the exercise protocol. The phototherapy device 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 | Participants enrolled in this group performed a training protocol for 12 weeks with light application before and after the exercise protocol. The phototherapy device 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 | Participants enrolled in this group performed a training protocol for 12 weeks with light application before and after the exercise protocol. The phototherapy device 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 D, received program 2 before strength training, and 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.
Change from baseline Maximum voluntary contraction in the isokinetic dynamometer (MVC) at 12 weeks
Functional performance measure - performed in baseline, 4 weeks, 8 weeks and 12 weeks after the beginning of the muscular training
Measured: 12 weeks
Change from baseline Concentric Torque at 12 weeks
Functional performance measure - performed in baseline, 4 weeks, 8 weeks and 12 weeks after the beginning of the muscular training
Measured: 12 weeks
Secondary outcomes (1)
1-RM test
Functional performance measure - performed in baseline, 4 weeks, 8 weeks and 12 weeks after the beginning of the muscular training. This test estimated the load of the exercises.
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 posted22 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2016
- Study completionOct 2016
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 AdaptationStudies 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
- Parallel groups
- 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 Leal-Junior, PhD, Study director, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02715050
- Sponsor's protocol ID
- PhD437.894
- Status last verified
- Oct 2016
- First submitted
- 11 Mar 2016
- Last updated
- 20 Oct 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