Protocol summary

Study aim
Investigation of the effect of low-level laser on muscle performance in people 20 to 35 years old
Design
A double-blinded, placebo-controlled, randomized clinical trial
Settings and conduct
Place of study performance: Sports medicine ward, Taleghani Hospital, Shahid Beheshti University of Medical Sciences Study protocol: 50 patients referring to the sports medicine ward from April 2018 to March 2019 who met the inclusion criteria, were included after explaining the study protocol and signing informed consent. The study was double-blinded. The participant didn’t know in which group is settled and the operator couldn't differentiate between active and placebo laser.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20-35, No history of regular exercise during the past 3 months, No history of professional exercise throughout life Exclusion criteria: musculoskeletal disorders prohibiting the use of a treadmill or weight, Consuming any drug or supplements, History of Quadriceps femoris or Hamstring muscles injury
Intervention groups
Treatment group: The participants that in the second session, before the exercise, received one session of the active laser at 810 nm wavelength and 60Hz frequency on 3 points of rectus femoris muscle, 30 seconds on each point (the laser device brand MPTC, model LMPT2000, made in Iran). The distance between the Anterior Superior Iliac Spine 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 that in the second session, before the exercise, received a laser with the probe off with the same protocol
Main outcome variables
Number of weight repetitions, the blood level of lactate, Fatigue(measured subjectively by the Rating of Perceived Scale from 6 to 20), Muscle pain (measured subjectively by scoring from 1 to 10)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200415047097N1
Registration date: 2020-06-08, 1399/03/19
Registration timing: retrospective

Last update: 2020-06-08, 1399/03/19
Update count: 0
Registration date
2020-06-08, 1399/03/19
Registrant information
Name
Nina Hazegh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3263 4143
Email address
h.anahita64@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-02, 1397/01/13
Expected recruitment end date
2019-03-16, 1397/12/25
Actual recruitment start date
2018-04-07, 1397/01/18
Actual recruitment end date
2018-12-17, 1397/09/26
Trial completion date
2018-12-17, 1397/09/26
Scientific title
Effect of low-level laser therapy on muscle performance of young adults
Public title
Effect of low-level laser therapy on muscle performance of young adults
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 20 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 50
Actual sample size reached: 50
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Third floor, Medicine faculty, Kudakyar St., Shahid Shahriary Sq., Shahid Chamran highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985717434
Approval date
2018-07-17, 1397/04/26
Ethics committee reference number
IR.SBMU.MSP.REC.1397.459

Health conditions studied

1

Description of health condition studied
Rehabilitation
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
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).

2

Description
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

Secondary outcomes

1

Description
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)

2

Description
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)

Intervention groups

1

Description
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.
Category
Rehabilitation

2

Description
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.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Taleghani hospital
Full name of responsible person
Nina Hazegh
Street address
Ayatollah Taleghni hospital, Shahid Arabi st., Yaman st., Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 23031
Email
taleghani@sbmu.ac.ir
Web page address
https://taleghani.sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Beside Ayatollah Taleghani hospital, Shahid Arabi st., Yaman st., Shahid Chamran highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Web page address
http://sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti university of medical sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nina Hazegh
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
No7., Masud deadend, Golestan deadend, Jeishir St., 3rd Moshtagh St.
City
Isfahan
Province
Isfehan
Postal code
8158161543
Phone
098 31 32634143
Email
h.anahita64@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nina Hazegh
Position
Specialist physician
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
No 7 masud dead end, Golestan avenue, Sarvestan street, Jeishir street, 3rd Moshtagh street
City
Isfahan
Province
Isfehan
Postal code
8158161543
Phone
+98 31 3263 4143
Fax
Email
h.anahita64@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nina Hazegh
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
No7., Masud deadend, Golestan deadend, Jeishir St., 3rd Moshtagh St.
City
Isfahan
Province
Isfehan
Postal code
8158161543
Phone
0098 31 2634143
Email
h.anahita64@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Using the data is allowed after the participants are non-recognizable
When the data will become available and for how long
Beginning the data access 6 months after the results are published
To whom data/document is available
All researchers in university associations
Under which criteria data/document could be used
Data analysis is allowed for use in meta-analyses and clinical review studies
From where data/document is obtainable
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.
What processes are involved for a request to access data/document
after receiving the request and recognizing the identity of the person who has sent the request, the data will be sent in a week
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