Cardiometabolic HIIT-RT Study

Study Overview
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Brief Summary
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Several studies have shown relationship between exercise intensity and improvement cardiometabolic health such as body composition, endothelial function, blood pressure and blood lipids. It has been suggested that high intensity interval training and also strength or resistance training generate positive effects on metabolic risk factors, nevertheless the comparison between both types of training and their combination has not yet provided conclusive evidence. Also, it has been shown that dietary restriction has similar or more positive effects that exercise alone and the effect is greater when it is combined with exercise. For these reasons, it is necessary to clarify which type of training, in combination with a dietary restriction, is more effective to improve cardiometabolic health

Detailed Description
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The investigators hypothesized that high intensity interval, resistance training or combined training would result in similar improvements in cardiometabolic health as compared to the usual clinical care in a cohort of sedentary overweight (age 30-50 years old).

Official Title
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High Intensity Interval- vs Resistance or Combined- Training for Improving Cardiometabolic Health in Overweight Adults (Cardiometabolic HIIT-RT Study): Study Protocol for a Factorial Randomised Controlled Trial

Conditions
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Metabolic Diseases, Overweight, Motor Activity

Intervention / Treatment
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* Behavioral: High Intensity Interval
* Behavioral: Resistance training
* Behavioral: Plus: High Intensity Interval + Resistance Training
* Other: Usual clinical care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets at least one criteria for metabolic Syndrome (IDF 2006): Central obesity: waist circumference ≥90cm (men) ≥80cm (women); triglycerides ≥ 150mg/dl; HDL-c <40mg/dl (men) <50 (women); Blood pressure ≥130/85mmHg and fasting plasma glucose ≥ 100mg/dL. 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: 30 Years
Maximum Age: 50 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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Intensity Interval<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 during adaptation (first 4 weeks) and 500 kcal after week number 4 until the end of training. | Behavioral: High Intensity Interval<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: Resistance training<br>Completing a resistance circuit (including upper and lower muscle groups) as many times as needed according to subject weight until expenditure of 300 kcal during adaptation (first 4 weeks) at 20-30% of 1 one-rep max and 500 kcal after week number 4 until the end of training, at 40-60% of one-rep max. | Behavioral: Resistance 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: Plus: High Intensity Interval + Resistance Training<br>Walking on a treadmill as intervention 1 until 50% the energy expenditure prescribed is reached, then completing a resistance circuit until 100% energy expenditure is reached. Exercise will be performed at three sessions per week. | Behavioral: Plus: High Intensity Interval + Resistance Training<br>* Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.<br>|
| Placebo Comparator: Usual clinical care<br>This group will receive the usual clinical care according to the consensus recommendations of the national goals for cardiovascular health promotion and disease reduction of the American Heart Association and Colombian guidelines COLDEPORTES. | Other: Usual clinical care<br>* Dietary restriction (1300-1500kcal) 50-52% carbohydrates, 33-35% fat, 15-20% protein<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 and 12 weeks immediately after the interventions ends | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in body Composition as measured by Dual Energy X-ray Absorptiometry | Changes in abdominal and total adiposity (DEXA), lean tissue mass and bone mass (DEXA) the 12 weeks intervention program | Baseline and 12 weeks immediately after the interventions ends | 
| Body Weight |  | Baseline and 12 weeks immediately after the interventions ends | 
| Body Mass Index | BMI will be calculated as the body weight in kilograms divided by the square of the height in meters. | Baseline and 12 weeks immediately after the interventions ends | 
| Blood Pressure |  | Baseline and 12 weeks immediately after the interventions ends | 
| Change from Baseline in peak uptake of volume of oxygen | It will be determined using a maximum treadmill exercise test (Precor TRM 885, Italy) following the modified Balke protocol | Baseline and 12 weeks immediately after the interventions ends | 
| 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 and 12 weeks immediately after the interventions ends | 
| Change from Baseline in Flexibility using the sit and reach test |  | Baseline and 12 weeks immediately after the interventions ends | 
| Change from Baseline in LDL Cholesterol |  | Baseline and 12 weeks immediately after the interventions ends | 
| Change from Baseline in HDL Cholesterol |  | Baseline and 12 weeks immediately after the interventions ends | 
| Change from Baseline in Triglycerides |  | Baseline and 12 weeks immediately after the interventions ends | 
| Change from Baseline in Glucose |  | Baseline and 12 weeks immediately after the interventions ends | 
| Change from Baseline in Hemoglobin A1c |  | Baseline and 12 weeks immediately after the interventions ends | 
| 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 | 
| 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 and 12 weeks immediately after the interventions ends | 
| 24-hour dietary recall | Dietary data will be collected from participants on 24h of their study enrollment. Prior to administration of the 24HR, each subject received two-dimensional food models with depiction of foods and serving sizes in order to assist in reporting portion sizes of food intake. | Baseline and 12 weeks immediately after the interventions ends | 
| Aortic pulse wave velocity (PWVao) and augmentation index (AIx) | PWVao and AIx will be measured with oscillometric method using the occlusion technique. | Baseline and 12 weeks immediately after the interventions ends |