Clinical trial NCT02738385: Intensity Training and Cardiovascular Health in Colombian Adults
Official title: High Intensity Interval- vs Moderate Training on Biomarkers of Endothelial and Cardiovascular Health in Adults: Effect of Postprandial Period
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Diseases
Lead sponsor: Universidad Santo Tomas
Sponsor class: OTHER
First posted: 2016-04-14
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD)
timeFrame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Secondary outcomes:
measure: Change from Baseline in LDL Cholesterol
timeFrame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
measure: Change from Baseline in HDL Cholesterol
timeFrame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
measure: Change from Baseline in Triglycerides
timeFrame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
measure: Change from Baseline in Glucose
timeFrame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
measure: Change from Baseline in Heart rate variability
timeFrame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
measure: Aortic pulse wave velocity (PWVao)
timeFrame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
measure: Change from Baseline in muscular fitness
timeFrame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
measure: Change from Baseline in Flexibility using the sit and reach test
timeFrame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
measure: Change from Baseline in peak uptake of volume of oxygen
timeFrame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
measure: Change from Baseline in Blood Pressure
timeFrame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
measure: Change from Baseline in Body Mass Index
timeFrame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
measure: Change from Baseline in Body Mass
timeFrame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
measure: Change from Baseline in Quality & satisfaction with life by SF Community - short-form survey (SF-12™) Colombian version
timeFrame: Baseline and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
measure: Augmentation index (AIx)
timeFrame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Robinson Ramírez Vélez Ph.D
Study officials:
affiliation: Universidad del Rosario
name: Robinson Ramírez Vélez, Ph.D
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.