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Intensity Training and Cardiovascular Health in Colombian Adults

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02738385
Acronym
HIIT-Heart
Enrollment
30
Registered
2016-04-14
Start date
2015-06-30
Completion date
2016-10-31
Last updated
2016-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Diseases

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.

Interventions

BEHAVIORALHigh Intensity Interval Training

Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.

Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.

Sponsors

Universidad Santo Tomas
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD)Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.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

MeasureTime frameDescription
Change from Baseline in HDL CholesterolBaseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in TriglyceridesBaseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in GlucoseBaseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Heart rate variabilityBaseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.HRV will be performed according to current recommendations by European Society of Cardiology using an evaluated share-ware
Aortic pulse wave velocity (PWVao)Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.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).
Change from Baseline in muscular fitnessBaseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.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 LDL CholesterolBaseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in peak uptake of volume of oxygenBaseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Blood PressureBaseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Change from Baseline in Body Mass IndexBaseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.BMI will be calculated as the body weight in kilograms divided by the square of the height in meters.
Change from Baseline in Body MassBaseline, 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 versionBaseline and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
Augmentation index (AIx)Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.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).
Change from Baseline in Flexibility using the sit and reach testBaseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.It will be determined using a maximum treadmill exercise test (Precor TRM 885, Italy) following the modified Balke protocol

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026