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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: REBEC
Last refreshed on: 29 May 2023
Main ID:  RBR-28mjwb
Date of registration: 11/03/2015
Prospective Registration: No
Primary sponsor: Universidade Federal de São Paulo - UNIFESP/EPM
Public title: Effects lasertherapy on physical exercise in elderly women.
Scientific title: Effects of low-level laser therapy on isokinetic muscle performance in elderly women.
Date of first enrolment: 01/03/2013
Target sample size:
Recruitment status: Recruitment completed
URL:  http://ensaiosclinicos.gov.br/rg/RBR-28mjwb
Study type:  Intervention
Study design:  Clinical trial of treatment, randomized, controlled, parallel, double-blind, three-arm.  
Phase:  N/A
Countries of recruitment
Brazil
Contacts
Name: Patrícia Gabrielli Vassão   Alves
Address:  Rua Silva Jardim 11015-020 Santos Brazil
Telephone: +55(13)38783823
Email: patriciavassao@gmail.com
Affiliation:  Universidade Federal de São Paulo - UNIFESP/EPM
Name: Patrícia Gabrielli Vassão   Alves
Address:  Rua Silva Jardim 11015-020 Santos Brazil
Telephone: +55(13)38783823
Email: patriciavassao@gmail.com
Affiliation:  Universidade Federal de São Paulo - UNIFESP/EPM
Key inclusion & exclusion criteria
Inclusion criteria: Females; age between 60 to 70 years old; full active range of motion and no pain in the hip, knee and ankle; body mass index between 18 to 27kg/cm ², taking into account height and weight; active or irregularly active, second International Physical Activity Questionnaire short version.
Exclusion criteria: Pain in the spine or lower limbs; history of trauma or previous surgery in the lower limbs or spine; history of muscle injury the femoral quadriceps, coxofemoral subluxation of the joint; osteoarthritis of the hip and or knee; rheumatic, degenerative or neurological diseases; fibromyalgia; hypertension and uncontrolled diabetes mellitus.

Age minimum: 60Y
Age maximum: 70Y
Gender: F
Health Condition(s) or Problem(s) studied
Muscle fatigue, aged
G11.427.550
M01.060.116.100
Intervention(s)
Other
Volunteers will be randomly allocated to Control Group: 26 women no submitted to muscle strength and laser, Active Laser Group: 26 women to muscle strength associated with active laser in final session and Placebo Laser Group: 26 women to muscle strength associated with placebo laser in final session. All participants, except those included in the control group, will be submitted to the strength muscle program and active laser therapy or placebo interventions for 8 weeks. The training program will consist of 2 sets of 15 repetitions knee flexion-extension performed with a load corresponding to 60% of 1- Maximum Repetition during the first two weeks and 3 sets of 15 repetitions with 80% of 1- Maximum Repetition during six weeks. The Laser will be applied on the quadriceps femoris of dominant lower limb immediately after each training session. Active Laser (808 nm wavelength, 100 mW, energy 7.0 J per point, energy density 250J/cm ², the total energy of 56 J and time per point 1 minute and 10 seconds) or an identical Placebo Laser (without irradiation) will be used in Active Laser Group and Placebo Laser Group respectively. Irradiation will be applied in direct contact with the skin.
E02.594.540
E02.779.483.875
Primary Outcome(s)
Increased muscle strength in both trained groups, by increasing the load values, based on the value of 1 repetition maximum, after the training program. Being statistical significance in the group irradiated with active laser.
Secondary Outcome(s)
Increased muscle performance by reducing fatigue index and increased torque, total work and power variables of the extensor muscles of the dominant member knee in groups submitted to muscle strengthening. Being statistically lower for the index of fatigue and increased paw torque, total work and average power in the group irradiated with active laser.
Decreased peripheral muscle fatigue in both groups submitted to muscle strengthening through the electromyographic signal obtained during submaximal contractions 60 before and after strength training program. Being statistical increased in the group irradiated with active laser.
Decreased peripheral muscle fatigue in both groups submitted to muscle strengthening, through blood samples obtained previously and after submaximal contractions 60 before and after strength training program. Being statistical lower in the group irradiated with active laser.
Secondary ID(s)
Source(s) of Monetary Support
Fundação de Amparo a Pesquisa do Estado de São Paulo
Secondary Sponsor(s)
Universidade Federal de São Paulo - UNIFESP/EPM
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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