Cardiometabolic HIIT-RT Study

Not Applicable

Completed

• Conditions: Metabolic Diseases; Overweight; Motor Activity

• Registration Number: NCT02715063
• Lead Sponsor: Universidad Santo Tomas

Brief Summary

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

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).

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-03-08
• Study First Submitted QC: 2016-03-16
• Study First Posted: 2016-03-22
• Primary Completion: 2016-12
• Study Completion: 2017-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD)	Baseline and 12 weeks immediately after the interventions ends	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.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in muscular fitness	Baseline and 12 weeks immediately after the interventions ends	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®
Change from Baseline in peak uptake of volume of oxygen	Baseline and 12 weeks immediately after the interventions ends	It will be determined using a maximum treadmill exercise test (Precor TRM 885, Italy) following the modified Balke protocol
Change from Baseline in Triglycerides	Baseline and 12 weeks immediately after the interventions ends
Change from Baseline in Heart rate variability	Baseline and 12 weeks immediately after the interventions ends	HRV will be performed according to current recommendations by European Society of Cardiology using an evaluated share-ware
Change from Baseline in body Composition as measured by Dual Energy X-ray Absorptiometry	Baseline and 12 weeks immediately after the interventions ends	Changes in abdominal and total adiposity (DEXA), lean tissue mass and bone mass (DEXA) the 12 weeks intervention program
Blood Pressure	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
Body Mass Index	Baseline and 12 weeks immediately after the interventions ends	BMI will be calculated as the body weight in kilograms divided by the square of the height in meters.
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 Hemoglobin A1c	Baseline and 12 weeks immediately after the interventions ends
Body Weight	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 Glucose	Baseline and 12 weeks immediately after the interventions ends
24-hour dietary recall	Baseline and 12 weeks immediately after the interventions ends	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.
Aortic pulse wave velocity (PWVao) and augmentation index (AIx)	Baseline and 12 weeks immediately after the interventions ends	PWVao and AIx will be measured with oscillometric method using the occlusion technique.

Trial Locations

Locations (1)

Robinson Ramírez Vélez Ph.D; 🇨🇴 Bogotá, Cundinamarca, Colombia