Intensity Training and Cardiovascular Health in Colombian Adults

Study Overview
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Brief Summary
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Several studies have shown relationship between exercise intensity and improvement cardiometabolic health. It has been suggested that high intensity interval training and also moderate training generate positive effects on metabolic risk factors. For these reasons, it is necessary to clarify which type of training, is more effective to improve cardiometabolic health in latinamerican population.

Official Title
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High Intensity Interval- vs Moderate Training on Biomarkers of Endothelial and Cardiovascular Health in Adults: Effect of Postprandial Period

Conditions
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Metabolic Diseases

Intervention / Treatment
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* Behavioral: High Intensity Interval Training
* Behavioral: Moderate Intensity Interval Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent. Interested in improving health and fitness. Exclusion Criteria: Systemic infections. Weight loss or gain of >10% of body weight in the past 6 months for any reason. Currently taking medication that suppresses or stimulates appetite. Uncontrolled hypertension: systolic blood pressure 160 mm Hg or diastolic blood pressure 95 mm Hg on treatment. Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy). Asthma. Diagnosed diabetes (type 1 or 2), fasting impaired glucose tolerance (blood glucose 118 mg/dL), or use of any anti-diabetic medications. Currently taking antidepressant, steroid, or thyroid medication, unless dosage is stable (no change for 6 months). Any active use of illegal or illicit drugs. Current exerciser (>30 min organized exercise per week). Indication of unsuitability of current health for exercise protocol (PARQ). Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Intensity Interval Training<br>Walking on a treadmill 4min at 80-90% peak heart rate and recovery 4 min at 65% peak heart rate until expenditure of 300 kcal until the end of training. | Behavioral: High Intensity Interval Training<br>* Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.<br>|
| Active Comparator: Moderate Intensity Interval Training<br>Walking on a treadmill at 60-80% peak heart rate until expenditure of 300 kcal until the end of training. | Behavioral: Moderate Intensity Interval Training<br>* Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD) | FMD will be measured using the guidelines reported by Corretti et al. The diameter of the brachial artery will be assessed using a high-resolution ultrasound device (Siemens SG-60, USA), equipped with a 7.5 MHz linear array transducer | Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in LDL Cholesterol |  | Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. | 
| Change from Baseline in HDL Cholesterol |  | Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. | 
| Change from Baseline in Triglycerides |  | Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. | 
| Change from Baseline in Glucose |  | Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. | 
| Change from Baseline in Heart rate variability | HRV will be performed according to current recommendations by European Society of Cardiology using an evaluated share-ware | Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. | 
| Aortic pulse wave velocity (PWVao) | PWVao (m s-1) will be performed within 3 to 4 minutes with the oscillometric, occlusive device, the Arteriograph. The measurement will be taken in a supine position and were accepted if the quality indicator of the recordings was within the acceptable range (i.e., if the standard deviation [SD] of the beat-to-beat measured PWVao values was less than 1.1 m/sec). | Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. | 
| Change from Baseline in muscular fitness | Muscular fitness (MF) will be assessed using handgrip test (maximum handgrip strength assessment) using a standard adjustable handle analogue handgrip dynamometer T-18 TKK SMEDLY III® | Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. | 
| Change from Baseline in Flexibility using the sit and reach test | It will be determined using a maximum treadmill exercise test (Precor TRM 885, Italy) following the modified Balke protocol | Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. | 
| Change from Baseline in peak uptake of volume of oxygen |  | Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. | 
| Change from Baseline in Blood Pressure |  | Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. | 
| Change from Baseline in Body Mass Index | BMI will be calculated as the body weight in kilograms divided by the square of the height in meters. | Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. | 
| Change from Baseline in Body Mass |  | Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. | 
| Change from Baseline in Quality & satisfaction with life by SF Community - short-form survey (SF-12™) Colombian version |  | Baseline and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. | 
| Augmentation index (AIx) | AIx (%) will be performed within 3 to 4 minutes with the oscillometric, occlusive device, the Arteriograph. The measurement will be taken in a supine position and were accepted if the quality indicator of the recordings was within the acceptable range (i.e., if the standard deviation [SD] of the beat-to-beat measured AIx values was less than 1.1 m/sec). | Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal. |