Intensity Training and Cardiovascular Health in Colombian Adults (HIIT-Heart)

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Diseases
• Intervention / Treatment: Behavioral: High Intensity Interval Training; Behavioral: Moderate Intensity Interval Training

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Bogotá, Colombia
    • Robinson Ramírez Vélez Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High Intensity Interval Training; 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; Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
Active Comparator: Moderate Intensity Interval Training; 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; Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Universidad Santo Tomas
• Investigators: Study Director: Robinson Ramírez Vélez, Ph.D, Universidad del Rosario

Publications and helpful links

General Publications

• Ramirez-Velez R, Tordecilla-Sanders A, Tellez-T LA, Camelo-Prieto D, Hernandez-Quinonez PA, Correa-Bautista JE, Garcia-Hermoso A, Ramirez-Campillo R, Izquierdo M. Effect of Moderate- Versus High-Intensity Interval Exercise Training on Heart Rate Variability Parameters in Inactive Latin-American Adults: A Randomized Clinical Trial. J Strength Cond Res. 2020 Dec;34(12):3403-3415. doi: 10.1519/JSC.0000000000001833.
• Ramirez-Velez R, Hernandez-Quinones PA, Tordecilla-Sanders A, Alvarez C, Ramirez-Campillo R, Izquierdo M, Correa-Bautista JE, Garcia-Hermoso A, Garcia RG. Effectiveness of HIIT compared to moderate continuous training in improving vascular parameters in inactive adults. Lipids Health Dis. 2019 Feb 4;18(1):42. doi: 10.1186/s12944-019-0981-z.
• Ramirez-Velez R, Correa-Rodriguez M, Tordecilla-Sanders A, Aya-Aldana V, Izquierdo M, Correa-Bautista JE, Alvarez C, Garcia-Hermoso A. Exercise and postprandial lipemia: effects on vascular health in inactive adults. Lipids Health Dis. 2018 Apr 3;17(1):69. doi: 10.1186/s12944-018-0719-3.
• Ramirez-Velez R, Tordecilla-Sanders A, Tellez-T LA, Camelo-Prieto D, Hernandez-Quinonez PA, Correa-Bautista JE, Garcia-Hermoso A, Ramirez-Campillo R, Izquierdo M. Similar cardiometabolic effects of high- and moderate-intensity training among apparently healthy inactive adults: a randomized clinical trial. J Transl Med. 2017 May 30;15(1):118. doi: 10.1186/s12967-017-1216-6. Erratum In: J Transl Med. 2017 Jun 13;15(1):136.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: April 8, 2016
• First Posted (Estimate): April 14, 2016

Study Record Updates

• Last Update Posted (Estimate): October 25, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases
• Other Study ID Numbers: 01-1802-2013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO