A Phase 1 interventional study of Phototherapy in Obesity;, sponsored by Universidade Federal de Sao Carlos. Status unknown at 1 site in Brazil. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2014-06-02.
Sponsored by Universidade Federal de Sao Carlos · Phase 1, Interventional, and Treatment
Obesity is a chronic disease of increasing prevalence, being currently considered a global epidemic, including children, adolescents, adults and the elderly of different nationalities and ethnicities, socioeconomic levels, education levels. Non-pharmacological therapeutic interventions, such as physical exercise and fitness healthy eating strategies seem to be increasingly studied and recommended for healthy weight loss. In addition, therapies that can complement the effect of exercise and diet for reducing body weight are considerate important strategies. Thus, experimental evidence shows that the use of laser therapy combined with exercise swimming was effective in controlling the lipid profile, reducing the mass of adipose tissue, suggesting increased metabolic activity and changes in lipid metabolism.
To investigate the effect of the use of therapeutic laser when associated to exercise like response to new therapy for weight loss and decrease of dyslipidemias levels.
Methods:
During 20 weeks, each patients will receive 3 session of exercise with duration of 1 hour. Each session of exercise will composed of aerobic exercise and resistence exercise. After training session, each patient will receive application of phototherapy during 16 minutes. The protocol of phototherapy appplication is described in link "interventions"
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 64 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Universidade Federal de Sao Carlos is the lead sponsor of 85 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
After the pre-selection in the initial interview, the volunteers who contemplate all the inclusion criteria will be referred for clinical evaluation with an interdisciplinary health team and the electrocardiogram stress test to verify the release of the practice of physical exercises proposed by the project .
alimentation information: a nutritionist provides nutritional orientation; exercise training: 3 days by week the patients will have specific sessions of resistance training (30 minutes) and aerobic training (30 minutes); phototherapy: all patients will received application of phototherapy after exercise session. The phototherapy will be applicated in abdominal and dorsal circumference/ quadriceps and biceps femoral. In Sham group,the equipment will be off.
phototherapy: all patientes will received application of phototherapy after exercise session. The phototherapy will be applicated in abdominal and dorsal circumference/ quadriceps and biceps femoral. Type Ga-Al-As Wavelength 808nm Frenquency Continue wave Optical output 100mW Spot diameter 0.6mm Power density 60W/cm2 Energy per minute 6J/point Number of Points 64points Total energy delivered 48J
Radiation: Phototherapy
phototherapy: all patientes will received application of phototherapy after exercise session. The phototherapy will be applicated in abdominal and dorsal circumference/ quadriceps and biceps femoral. Type Ga-Al-As Wavelength 808nm Frenquency Continue wave Optical output 100mW Spot diameter 0.6mm Power density 60W/cm2 Energy per minute 6J/point Number of Points 64points Total energy delivered 48J
Also known as: laser, lasertherapy, low-level laser therapy
Anthropometric measure
Weight body: this measure would occurs during each week.
Time frame: the measure occur up to 20 weeks
anthropometric parameter
total body fat: this measure would occurs during each week
Time frame: the measure occur up to 20 weeks
anthropometric parameter
visceral body fat: this measure would occurs during each week
Time frame: the measure occur up to 20 weeks
anthropometric parameter
total muscle
Time frame: the measure occur up to 20 weeks
Primary biochemical analyzes
The primary biochemical: glicemic variables (glucose and insulin)
Time frame: the measures occur up to 20 weeks
Primary biochemical analyzes
the lipids variables (total cholesterol; triglycerides; low density lipoprotein; very low density lipoprotein; high density lipoprotein)
Time frame: the measure occur up to 20 weeks
measure of neuropeptide
neuropeptides variables: neuropeptide Y (NPY); agouti-related peptide (agRP); melanotropic hormone (MCH); Leptine; alpha melanocyte stimulating (alpha MSH); Pro-opiomelanocortin (POMC); Cocaine-Amphetamine-Regulated Transcript (CART);
Time frame: measures up to 20 weeks
measure of interleukines and citokines
interleukines and citokines variables: iL-1; iL-4; iL-6; iL-10; c reactive protein.
Time frame: the measure occur up to 20 weeks
This study is status unknown, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Universidade Federal de Sao Carlos