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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01391195
Other study ID # CAAE - 0100.0.135.000-05
Secondary ID
Status Completed
Phase Phase 1
First received July 7, 2011
Last updated July 12, 2011
Start date January 2006
Est. completion date October 2007

Study information

Verified date December 2005
Source Universidade Federal de Sao Carlos
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial Summary

The study hypothesis is an increase in muscle performance and a higher aerobic adaptation of young women submitted to chronic endurance training program associated to low level laser therapy when compared to chronic aerobic training alone.


Description:

The study assessed women muscle performance in isokinetic dynamometry, ventilatory parameters such as ventilatory threshold, VO2Peak, VO2Max, Ventilation. Maximal load in cycle ergometer test (Balke's protocol), Borg Scale and Heart rate were assessed too.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date October 2007
Est. primary completion date April 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 28 Years
Eligibility Inclusion Criteria:

- healthy young women volunteers

- women with a beginner or moderately trained pattern of physical activity

- body Mass Index (BMI) between 18 and 25kg/m2

Exclusion Criteria:

- previous injury to the femoral quadriceps or hamstrings muscles (within 6 months prior to study)

- osseous or articular disorder in the lower limbs

- cardiovascular system disorders or systemic disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Phototherapy by low level laser therapy
Phototherapy by low level laser therapy during 9 weeks

Locations

Country Name City State
Brazil Universidade Federal de Sao Carlos São Carlos São Paulo

Sponsors (2)

Lead Sponsor Collaborator
Universidade Federal de Sao Carlos Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

Baroni BM, Leal Junior EC, De Marchi T, Lopes AL, Salvador M, Vaz MA. Low level laser therapy before eccentric exercise reduces muscle damage markers in humans. Eur J Appl Physiol. 2010 Nov;110(4):789-96. doi: 10.1007/s00421-010-1562-z. Epub 2010 Jul 3. — View Citation

Baroni BM, Leal Junior EC, Geremia JM, Diefenthaeler F, Vaz MA. Effect of light-emitting diodes therapy (LEDT) on knee extensor muscle fatigue. Photomed Laser Surg. 2010 Oct;28(5):653-8. doi: 10.1089/pho.2009.2688. Epub 2010 Jul 13. — View Citation

Ferraresi C, de Brito Oliveira T, de Oliveira Zafalon L, de Menezes Reiff RB, Baldissera V, de Andrade Perez SE, Matheucci Júnior E, Parizotto NA. Effects of low level laser therapy (808 nm) on physical strength training in humans. Lasers Med Sci. 2011 May;26(3):349-58. doi: 10.1007/s10103-010-0855-0. Epub 2010 Nov 18. — View Citation

Leal Junior EC, Lopes-Martins RA, Baroni BM, De Marchi T, Taufer D, Manfro DS, Rech M, Danna V, Grosselli D, Generosi RA, Marcos RL, Ramos L, Bjordal JM. Effect of 830 nm low-level laser therapy applied before high-intensity exercises on skeletal muscle recovery in athletes. Lasers Med Sci. 2009 Nov;24(6):857-63. doi: 10.1007/s10103-008-0633-4. Epub 2008 Dec 5. — View Citation

Leal Junior EC, Lopes-Martins RA, Dalan F, Ferrari M, Sbabo FM, Generosi RA, Baroni BM, Penna SC, Iversen VV, Bjordal JM. Effect of 655-nm low-level laser therapy on exercise-induced skeletal muscle fatigue in humans. Photomed Laser Surg. 2008 Oct;26(5):419-24. doi: 10.1089/pho.2007.2160. — View Citation

Leal Junior EC, Lopes-Martins RA, de Almeida P, Ramos L, Iversen VV, Bjordal JM. Effect of low-level laser therapy (GaAs 904 nm) in skeletal muscle fatigue and biochemical markers of muscle damage in rats. Eur J Appl Physiol. 2010 Apr;108(6):1083-8. doi: 10.1007/s00421-009-1321-1. Epub 2009 Dec 19. — View Citation

Leal Junior EC, Lopes-Martins RA, Vanin AA, Baroni BM, Grosselli D, De Marchi T, Iversen VV, Bjordal JM. Effect of 830 nm low-level laser therapy in exercise-induced skeletal muscle fatigue in humans. Lasers Med Sci. 2009 May;24(3):425-31. doi: 10.1007/s10103-008-0592-9. Epub 2008 Jul 23. — View Citation

Lopes-Martins RA, Marcos RL, Leonardo PS, Prianti AC Jr, Muscará MN, Aimbire F, Frigo L, Iversen VV, Bjordal JM. Effect of low-level laser (Ga-Al-As 655 nm) on skeletal muscle fatigue induced by electrical stimulation in rats. J Appl Physiol (1985). 2006 Jul;101(1):283-8. Epub 2006 Apr 20. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Fatigue Index of knee extensor muscles Fatigue Index of knee extensor muscles assessed in isokinetic dynamometry. nine weeks No
Primary Ventilatory threshold Ventilatory threshold quantified by a gas analyzer. nine weeks No
Primary VO2max VO2max quantified by a gas analyzer. nine weeks No
Primary VO2peak VO2peak quantified by a gas analyzer. nine weeks No
Primary Maximum load of effort on cycle ergometer (Balke's protocol). Maximum load of effort on cycle ergometer quantified in Watts. nine weeks No
Secondary Total work of knee extensor muscles Total work of knee extensor muscles assessed in isokinetic dynamometry nine weeks No
Secondary Peak torque of knee extensor muscles Peak torque of knee extensor muscles assessed in isokinetic dynamometry nine weeks No
Secondary Borg scale Subjective effort perception assessed by Borg scale nine weeks No
Secondary Heart rate Heart Rate assessed by cardiac frequency meter nine weeks No
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