Effects of High Intensity Interval Training and Combined Training in Type 2 Diabetic (T2D) Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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Type 2 diabetes (T2D) is a significant health problem worldwide due to its high prevalence and mortality. It is chronic metabolic disorder characterized by hyperglycemia resulting from a relative deficiency in insulin through either reduced insulin secretion or reduced insulin action or both. The subsequent chronic hyperglycaemia causes glycation of tissues, which almost inevitably leads to acute disturbances in metabolism and long term end organ damage, especially the blood vessels, heart, and nerves, and severe health complications. Individuals with T2D have reduced aerobic fitness characterized by lower peak pulmonary oxygen uptake. Many potential mechanisms could explain this impaired response, for example, reduced muscle blood flow and capillary density, defects in muscular oxygen diffusion, and lower mitochondrial oxygen utilization and function. T2D is also associated with lower baroreflex sensitivity and abnormal chronotropic response, altering heart rate regulation. In addition, prolonged hyperglycemia in T2D causes a number of pathological changes in vascular endothelial cells, increasing the production of reactive oxygen species and inflammatory cytokines that cause mitochondrial dysfunction and oxidative damage.

Official Title
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Effects of High Intensity Interval Training and Combined Training Associated With Photobiomodulation in Type 2 Diabetic (T2D) Patients: a Randomized Controlled Clinical Trial

Conditions
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Diabetes Mellitus, Type 2, High-Intensity Interval Training, Exercise Training, Hyperglycaemia Due to Type 2 Diabetes Mellitus

Intervention / Treatment
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* Other: Physical training
* Other: Light-Emitting Diode (LED) therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HIIT and LED therapy<br>Light-Emitting Diode (LED) therapy followed by physical training with high intensity interval training (HIIT) | Other: Physical training<br>* Type 2 diabetic patients will be subjected to different types of physical training (high intensity interval training or combined training).<br>Other: Light-Emitting Diode (LED) therapy<br>* Type 2 diabetic patients will be subjected to Light-Emitting Diode (LED) therapy (active or sham).<br>|
| Sham Comparator: High intensity interval training (HIIT)<br>Light-Emitting Diode (LED) therapy simulation followed by physical training with high intensity interval training (HIIT) | Other: Physical training<br>* Type 2 diabetic patients will be subjected to different types of physical training (high intensity interval training or combined training).<br>Other: Light-Emitting Diode (LED) therapy<br>* Type 2 diabetic patients will be subjected to Light-Emitting Diode (LED) therapy (active or sham).<br>|
| Experimental: Combined training and LED therapy<br>Light-Emitting Diode (LED) therapy followed by physical training with combined training | Other: Physical training<br>* Type 2 diabetic patients will be subjected to different types of physical training (high intensity interval training or combined training).<br>Other: Light-Emitting Diode (LED) therapy<br>* Type 2 diabetic patients will be subjected to Light-Emitting Diode (LED) therapy (active or sham).<br>|
| Sham Comparator: Combined training<br>Light-Emitting Diode (LED) therapy simulation followed by physical training with combined training. | Other: Physical training<br>* Type 2 diabetic patients will be subjected to different types of physical training (high intensity interval training or combined training).<br>Other: Light-Emitting Diode (LED) therapy<br>* Type 2 diabetic patients will be subjected to Light-Emitting Diode (LED) therapy (active or sham).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional exercise capacity | Oxygen consumption measurement during cardiopulmonary test | Change from Baseline to 12 weeks | 
| Incremental shuttle walking test | Distance in meters | Change from Baseline to 12 weeks | 
| Glycemic control | Evaluated by the percentage of glycated hemoglobin | Change from Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autonomic Nervous System | Assesment by Heat Rate Variability analysis | Change from Baseline to 12 weeks | 
| Musculoskeletal Function | Muscular strength and endurance will be evaluated by Isokinetic Dynamometry | Change from Baseline to 12 weeks | 
| 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 | 
| Endothelial Function | Endothelial function will be assessed by arterial flow-mediated dilation (FMD) | Change from Baseline to 12 weeks | 
| 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 | 
| Body mass index (BMI) | Weight and height will be combined to report BMI (kg/m2) | Change from Baseline to 12 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiopulmonary Exercise Test, Rehabilitation, Diabetes Mellitus, Type 2, Functional Capacity, Photobiomodulation Therapy