Comparative Study of the Use of Phototherapy and Ultrasound to Reduce Localized Fat
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 2
- 主要终点
- Abdominal skinfold change
研究概览
简要总结
Light and ultrasound can be interesting alternatives to reduce abdominal fat. Thus, the main objective of this study will be to evaluate the effects of these isolated techniques and their association in subcutaneous abdominal localized fat. These techniques will be used adding muscle electrostimulation in all groups. A total of 40 female participants will be recruited at the university outpatient, which will be distributed among four experimental groups: light + sham ultrasound + electrostimulation; light sham + ultrasound + electrostimulation; combined treatment (light + ultrasound) + electrostimulation; sham combined treatment + electrostimulation. The treatments will consist of eight sessions, twice a week for a month, being 90 minutes per session.
详细描述
The search for the ideal shape and the lifestyle that favours the increase of adipose depots are some factors responsible for the increasing demand for procedures to reduce localized fat. It has been shown that photobiomodulation (PBM) and low-frequency ultrasound (LOFU) can be interesting alternatives to treat this aesthetic dysfunction. However, there is no consensus about the best parameters for the application of these therapeutic resources. Thus, the main objective of this study will be to evaluate the effects of these isolated techniques and their association in subcutaneous abdominal localized fat.This will be a controlled, randomised, double-blind, single-centred clinical trial. Infrared light emitting diode - LED - (830±20 nm, 71 milliwatt per square centimeter mW/cm², 127.8 J/cm²), low-frequency ultrasound (30 kilohertz (kHz), 3 W/cm²) and combination of techniques will be used, adding muscle electrostimulation in all groups (2500 Hz, 30 bps, 50%). A total of 40 female participants will be recruited at the university outpatient, which will be distributed among four experimental groups that will compose the pilot study: PBM + sham ultrasound + electromyostimulation; PBM sham + LOFU + electromyostimulation; combined treatment (PBM + LOFU) + electromyostimulation; sham combined treatment + electromyostimulation. At each session, the participants will receive 30 minutes PBM with an abdominal strap, subsequent demarcation on the target area to be treated with LOFU for 30 minutes and completion with 20 minutes of electrically induced muscle contraction. The treatments will consist of eight sessions, twice a week for a month. The main outcome of this study will be abdominal skinfold reduction and the secondary variables will be including anthropometric data, local temperature, nutritional routine and physical activity data, quality of life, self-esteem, satisfaction grade with the treatment and visual changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Neither the participants involved in the study, nor the outcomes assessor will be aware of the groups formed, as well as the treatments received.
入排标准
- 年龄范围
- 25 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI of between 18.5 and 27.5 kg/m² (normotrophic or overweight body mass);
- •Fitzpatrick phototype from I to IV;
- •Who have fat located in the abdominal region characterized by abdominal skinfold higher than 20 mm;
- •Who are sedentary of perform physical activity whose intensity is equal to or less than 450 METs/minutes/week (metabolic equivalents = METs);
- •Who have stabilized weight, that is, who have not acquired or eliminated more than 2.5 kg in the 6 months preceding the screening;
- •Absence of signs/symptoms of disease.
排除标准
- •Women who have used drugs that alter body composition in the last 3 months prior to starting treatments; who use sensitizing agents, diuretics or are undergoing photodynamic therapy;
- •Participants who are undergoing aesthetic treatments to reduce abdominal/waist circumferences; those who have been previously submitted to abdominoplasty or liposuction surgeries; those who are on a diet therapy monitoring to reduce their measurements; those who are using or have taken drugs or food supplements in last 90 days, in order to reduce their measurements and their weight, which may affect their lipid metabolism, appetite or nutrients absorption; those who have been submitted previously to oophorectomy; those with signs and/or symptoms of climacteric at the menopause; pregnant or lactating women or who are planning a pregnancy before the end of treatment participation.
- •Participants who have abdominal hernia; osteoporosis; phlebitis and thrombophlebitis; autoimmune diseases; cardiovascular problems (hypertension, cardiac insufficiency, arrhythmia, thrombosis); metabolic dysfunctions (diabetes and thyroid disorders); hepatitis or other liver diseases (non-alcoholic fatty liver disease, cirrhosis); respiratory issues (asthma, chronic obstructive pulmonary disease); haematological disturbances (anaemia); renal; dermatological (reduced sensitivity); digestive disorders (gastritis, ulcers); neurological (dementia or schizophrenia), or who have cognitive impairment that may compromise the proper understanding of informed consent; who have already been affected by important inflammatory processes and/or who have a history of cancer;
- •Participants who present tattoos and/or piercings in the region to be treated, who use intrauterine devices, pacemakers, or other electromagnetic implants, as well as joint prostheses.
结局指标
主要结局
Abdominal skinfold change
时间窗: Before the start (Day 0), after the fourth session (Day 15) and after the treatments (Day 30).
This outcome will be measured in millimeters (mm) by direct reading using adipometer (Sanny, American Medical do Brasil Ltda., São Bernardo do Campo, Brazil).
次要结局
- Anthropometric data (height)(Day 0.)
- Anthropometric data (skinfold measures)(Day 0, Day 15 (abdominal and suprailiac skinfolds only), and Day 30.)
- Local temperature(Day 0 and Day 30.)
- Anthropometric data (body mass index)(Day 0, Day 15 and Day 30.)
- Bioimpedance analysis (fat mass percentage)(Day 0 and Day 30.)
- Physical activity assessment(Day 0, Day 15 and Day 30.)
- Anthropometric data (body weight)(Day 0, Day 15 and Day 30.)
- Anthropometric data (hip circumference)(Day 0, Day 15 and Day 30.)
- Nutritional assessment(Day 0, during the study period (3 times per week) and Day 30.)
- Self-esteem scale(Day 0 and Day 30.)
- Visual change assessment(Day 0 and Day 30.)
- Bioimpedance analysis (weight)(Day 0 and Day 30.)
- Anthropometric data (waist circumference)(Day 0, Day 15 (body weight, BMI, waist and hip circumferences, abdominal and suprailiac skinfold only), and Day 30.)
- Anthropometric data (waist/hip circumference ratio)(Day 0, Day 15 and Day 30.)
- Bioimpedance analysis (lean mass percentage)(Day 0 and Day 30.)
- Quality of life scale(Day 0 and Day 30.)
- Satisfaction degree with treatment(Day 30.)
研究者
Christiane Pavani
Clinical Professor
University of Nove de Julho