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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03420391
Other study ID # 113553
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 20, 2019
Est. completion date July 19, 2019

Study information

Verified date April 2020
Source University of Nove de Julho
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Recent studies with photobiomodulation therapy (PBMT) have shown positive results delaying skeletal muscle fatigue and improving the status of biochemical markers related to skeletal muscle damage when these therapies were applied before exercise. The aim of this project is to verify the effects of PBMT in improvement of skeletal muscle performance and skeletal muscle recovery in healthy male subjects. This project aim also to validate the concept that simultaneous use of three wavelengths and light sources lead to optimized action independently of time-window between irradiation and the exercise.


Description:

This is a randomized, triple-blinded, placebo-controlled trial. Sixty healthy untrained male subjects will be randomly allocated to six experimental groups: Placebo, Control, PBMT 5 mins, PBMT 3h, PBMT 6h and PBMT 24 hours. PBMT will be applied precisely two minutes after baseline MVC test. Then, after five minutes, 3, 6 hours or 1 day (24 hours) of PBMT the eccentric exercise protocol will be performed. We will analyze maximum voluntary contraction (MVC), creatine kinase (CK) activity and delayed onset muscle soreness (DOMS). Assessments will be performed at baseline, immediately after (1 minute), 1 hour, 24 and 48 hours after the eccentric exercise protocol.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 19, 2019
Est. primary completion date July 19, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria:

- Healthy

- not athletes or who engage in physical activity at most once a week

- Individuals should not present a history of musculoskeletal injury in the hip and knee regions in the two months prior to the studies

- they should not be using pharmacological agents and / or nutritional supplements

- They must attend 100% of the data collections.

Exclusion Criteria:

- Individuals who do not meet the criteria mentioned above or who present musculoskeletal damage during collection were excluded from the study.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Photobiomodulation Therapy (PBMT)
Phototherapy device - Multi Radiance Medical® (Solon, OH, EUA)

Locations

Country Name City State
Brazil Universidade Nove de Julho São Paulo

Sponsors (3)

Lead Sponsor Collaborator
University of Nove de Julho Fundação de Amparo à Pesquisa do Estado de São Paulo, University of Bergen

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Torque peak / maximum voluntary contraction - MVC Assessment was performed in the isokinetic dynamometer (System 4, Biodex®, USA) 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.
Secondary Delayed onset muscle soreness (DOMS) Assessment was performed through visual analogue scale (VAS). A visual analogue scale (VAS) of 100 mm was used as a self-rating of volunteers DOMS intensity, with assistance of a blinded researcher, where "0" corresponds to no pain and 100mm corresponds to the worst pain possible. 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.
Secondary Biochemical marker of muscle damage Analysis of Creatine Kinase (CK) levels 1 minute, 1 hour, 24 and 48 hours after the end of exercise protocol.
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