- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02474602
Phototherapy Applied in Association With Strength Training
Phototherapy Applied in Association of Muscle Training: Evaluation of Different Irradiation Protocols
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
SP
-
São Paulo, SP, Brazil, 01504-001
- Nove de Julho University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
The participants were excluded if they
- present some musculoskeletal injury during the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A - Active or Placebo Phototherapy
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. |
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.
Other Names:
|
|
Experimental: Group B - Active or Placebo Phototherapy
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. |
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.
Other Names:
|
|
Experimental: Group C - Active or Placebo Phototherapy
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. |
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.
Other Names:
|
|
Experimental: Group D - Active or Placebo Phototherapy'
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. |
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximum voluntary contraction in the isokinetic dynamometer (MVC)
Time Frame: 12 weeks
|
Functional performance measure
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
1-Repetition Maximum test in the leg press and leg extension machines (1-RM)
Time Frame: 12 weeks
|
Functional performance measure
|
12 weeks
|
|
Thigh perimetry
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Ernesto Cesar P Leal Junior, PhD, University of Nove de Julho
Publications and helpful links
General Publications
- Antonialli 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.
- 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.
- Seynnes 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Nove de Julho University
- 2013/19355-3 (Other Grant/Funding Number: FAPESP-Brazil)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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