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IRCT20200415047097N1 IRCT 2020-06-08 Shahid Beheshti University of Medical Sciences Effect of low-level laser therapy on muscle performance of young adults Effect of low-level laser therapy on muscle performance of young adults 2018-04-02 anticipated 50 Complete https://irct.ir/trial/47250 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: To minimize the risk of selection bias, block randomization was performed. The participants, according to their Body Mass Index or BMI, were divided into two subgroups of BMI less than 25 (22 participants) and BMI equal to 25 or more (28 participants). Randomization was carried out in each subgroup separately, with a block size of 4. 2 cards of A and 2 cards of B were shuffled and randomly put together and the operator of the randomization, according to the order that the cards were arranged, assigned the participants to groups A or B. The participant who had received card A, was placed in group A and received a real laser, whereas the participant who had received card B, was placed in group B and received a placebo. All of the randomization steps were carried out by the trial operators. The participants and the operators of randomization didn't know to which group A and B cards belong, Blinding description: To avoid performance bias, double-blinding was done; meaning that the participants didn’t know whether they were in the real laser or the placebo group and the laser therapy operator was unable to differentiate between active and placebo laser. The laser device was programmed by a nurse who was not in contact with the participants. Then a second operator who was blinded to the allocation of the subjects applied the phototherapy. The signals and sounds of the device in on and off mode were completely similar and the operator couldn’t differentiate whether it is on or off. So, both participants and operators were blinded to the type of treatment. N/A Rehabilitation. Intervention 1: Intervention group: The participants settled in group A due to the block randomization and in the second session, before the exercise, receive one session of the real laser at 810 nm wavelength, 60mW power, and 60Hz frequency for 30 seconds on 3 points of rectus femoris muscle, 30 seconds on each point. (Laser device brand MPTC, model LMPT2000, made in Iran). To find the points, the distance between the Anterior Superior Iliac Spine (ASIS) to the upper border of the patella was divided into 3 equal regions and the middle point of every region was considered as an irradiation point. Intervention 2: Control group: The participants settled in group B due to the block randomization and in the second session, before the exercise, received the placebo laser (with probe off) on 3 points of rectus femoris muscle, 30 seconds on each point. (Laser device brand MPTC, model LMPT2000, made in Iran). To find the points, the distance between the Anterior Superior Iliac Spine (ASIS) to the upper border of the patella was divided into 3 equal regions and the middle point of every region was considered as an irradiation point. Yes - There is a plan to make this available What will be shared: Using the data is allowed after the participants are non-recognizable When: Beginning the data access 6 months after the results are published To whom: All researchers in university associations Conditions: Data analysis is allowed for use in meta-analyses and clinical review studies Where to obtain: for accessing the data please send an e-mail to the address h.anahita64@yahoo.com Dr. Nina Hazegh. Name and the telephone number, the association, posting address, e-mail of the person who has requested for the data is necessary. How to obtain: after receiving the request and recognizing the identity of the person who has sent the request, the data will be sent in a week Comments:
public Nina Hazegh
No7., Masud deadend, Golestan deadend, Jeishir St., 3rd Moshtagh St.
Isfahan Iran (Islamic Republic of) 8158161543 098 31 32634143 h.anahita64@yahoo.com Shahid Beheshti University of Medical Sciences scientific Nina Hazegh
No 7 masud dead end, Golestan avenue, Sarvestan street, Jeishir street, 3rd Moshtagh street
Isfahan Iran (Islamic Republic of) 8158161543 +98 31 3263 4143 h.anahita64@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age in the range of 20-35 Being sedentary (no history of regular exercise during the past 3 months) No history of professional sport during the lifetime 20 years 35 years Both Any musculoskeletal disorder prohibiting the use of a treadmill or weight Consuming any drug or supplements Previous history of injury to Quadriceps femoris or Hamstring muscles Rehabilitation Rehabilitation Intervention group: The participants settled in group A due to the block randomization and in the second session, before the exercise, receive one session of the real laser at 810 nm wavelength, 60mW power, and 60Hz frequency for 30 seconds on 3 points of rectus femoris muscle, 30 seconds on each point. (Laser device brand MPTC, model LMPT2000, made in Iran). To find the points, the distance between the Anterior Superior Iliac Spine (ASIS) to the upper border of the patella was divided into 3 equal regions and the middle point of every region was considered as an irradiation point. Control group: The participants settled in group B due to the block randomization and in the second session, before the exercise, received the placebo laser (with probe off) on 3 points of rectus femoris muscle, 30 seconds on each point. (Laser device brand MPTC, model LMPT2000, made in Iran). To find the points, the distance between the Anterior Superior Iliac Spine (ASIS) to the upper border of the patella was divided into 3 equal regions and the middle point of every region was considered as an irradiation point. Level of the blood lactate. Timepoint: At the beginning of the study 3 days before the intervention and in the second session 20 minutes after the intervention. Method of measurement: Lactometer brand ECF (made in Italy) and brand Sensal No 74 lactometer kit (made in China), using a fingertip blood sample. The blood sample was collected by puncturing the fingertip using a lancet brand Ava (made in Iran). Number of knee extensions with a 10 kg weight. Timepoint: At the beginning of the study 3 days before the intervention and in the second session 5 minutes after the intervention. Method of measurement: Counting the number of complete knee extensions. Fatigue. Timepoint: At the beginning of the study 3 days before the intervention and 20 minutes after the intervention in the second session. Method of measurement: Scoring subjectively by the RPE (Rating of Perceived Exertion) scale, from 6 (minimum fatigue) to 20 (exhaustion). Muscle soreness. Timepoint: 2 days before the intervention (24 hours after the first session exercise) and 24 hours after the intervention. Method of measurement: Scoring subjectively from 1 (the least pain) to 10 (the maximum pain). Shahid Beheshti university of medical sciences Approved 2018-07-17 Ethics committee of Shahid Beheshti University of Medical Sciences Third floor, Medicine faculty, Kudakyar St., Shahid Shahriary Sq., Shahid Chamran highway, Tehran Tehran Tehran Iran (Islamic Republic of)