Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Effects of High Intensity Interval Training and Combined Training Associated With Photobiomodulation in Type 2 Diabetic (T2D) Patients: a Randomized Controlled Clinical Trial
Diabetes has become a widespread epidemic, primarily because of the increasing prevalence and incidence of type 2 diabetes (T2D). T2D is a significant cause of premature mortality and morbidity related to cardiovascular disease, blindness, kidney and nerve disease, and amputation. Physical activity improves blood glucose control and can prevent or delay T2D, along with positively affecting lipids, blood pressure, cardiovascular events, mortality, and quality of life. At present, although physical activity is a key element in the prevention and management of T2D, the most effective exercise strategy (intensity, duration, and type of exercise) for improving glucose control and reducing cardiometabolic risk in type 2 diabetes has not been defined. Studies with Light-Emitting Diode (LED) therapy have demonstrated its ability to promote pain relief, improve muscle and cardiopulmonary performance, minimize muscle fatigue, and stimulate wound healing. In relation to patients with T2D, who have prolonged conditions of hyperglycemia, studies to investigate the impact of photobiomodulation associated with physical training have not been found so far. The objective of this study is to investigate the effects of different types of physical training associated with Light-Emitting Diode (LED) therapy on cardiometabolic status and quality of life in patients with T2D.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | December 2022 |
Est. primary completion date | October 1, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - Age = 18 years; - Confirmed diagnosis of type 2 diabetes; - Sedentary lifestyle in the last six months, according to the criteria established by the American Heart Association (AHA). Exclusion Criteria: - Confirmed diagnosis of any (1) heart disease; (2) musculoskeletal disorder; (3) respiratory disease; (4) uncontrolled arterial hypertension; (5) peripheral neuropathy or (6) factors that limit the performance of any of the study evaluations and/or training. - During the study, individuals with a presence of less than 80% in the training sessions will be excluded. |
Country | Name | City | State |
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Brazil | UNINOVE | Sao Paulo | SP |
Lead Sponsor | Collaborator |
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University of Nove de Julho |
Brazil,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional exercise capacity | Oxygen consumption measurement during cardiopulmonary test | Change from Baseline to 12 weeks | |
Primary | Incremental shuttle walking test | Distance in meters | Change from Baseline to 12 weeks | |
Primary | Glycemic control | Evaluated by the percentage of glycated hemoglobin | Change from Baseline to 12 weeks | |
Secondary | Autonomic Nervous System | Assesment by Heat Rate Variability analysis | Change from Baseline to 12 weeks | |
Secondary | Musculoskeletal Function | Muscular strength and endurance will be evaluated by Isokinetic Dynamometry | Change from Baseline to 12 weeks | |
Secondary | Physical Activity Questionnaire | The level of physical activity will be assessed using the international questionnaire short version physical activity (IPAQ). The continuous score allows assessing energy expenditure expressed in MET minutes/week. The IPAQ categories include: Insufficiently active (does not perform any physical activity); Sufficiently active (conducts vigorous activity at least three days a week >600 MET - 1400 MET); Very active (performs more than three days per week of vigorous activity 1500 MET - 3000 MET). | Change from Baseline to 12 weeks | |
Secondary | Endothelial Function | Endothelial function will be assessed by arterial flow-mediated dilation (FMD) | Change from Baseline to 12 weeks | |
Secondary | Quality of Life Questionary | Assesment by using the questionnaire Medical Outcomes Study 36 - Item Short - Form Health Survey (SF36). The SF-36 has eight sections (Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning and Mental health). The scores are weighted sums of the questions in each section. Scores range from 0 - 100. Lower scores = more disability and higher scores = less disability. | Change from Baseline to 12 weeks | |
Secondary | Body mass index (BMI) | Weight and height will be combined to report BMI (kg/m2) | Change from Baseline to 12 weeks | |
Secondary | Other Biochemical Analyzes | Total cholesterol (Total-C) (mg/dl), low-density lipoprotein cholesterol (LDL-C) (mg/dl), high-density lipoprotein cholesterol (HDL-C) (mg/dl) and triglycerides (mg/dl) | Change from Baseline to 12 weeks |
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