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OpenTrials
Completed

NCT Number: NCT02738385

Intensity Training and Cardiovascular Health in Colombian Adults

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.

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Key information

Conditions

Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Robinson Ramírez Vélez Ph.D

Bogotá, Colombia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Intensity Interval Training

Behavioral

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

Moderate Intensity Interval Training

Behavioral

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

Primary outcomes

  1. Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD)

    Time frame: 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 outcomes

  1. Change from Baseline in LDL Cholesterol

    Time frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.

  2. Change from Baseline in HDL Cholesterol

    Time frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.

  3. Change from Baseline in Triglycerides

    Time frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.

  4. Change from Baseline in Glucose

    Time frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.

  5. Change from Baseline in Heart rate variability

    Time frame: Baseline, 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

  6. Aortic pulse wave velocity (PWVao)

    Time frame: 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).

  7. Change from Baseline in muscular fitness

    Time frame: Baseline, 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®

  8. Change from Baseline in Flexibility using the sit and reach test

    Time frame: Baseline, 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

  9. Change from Baseline in peak uptake of volume of oxygen

    Time frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.

  10. Change from Baseline in Blood Pressure

    Time frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.

  11. Change from Baseline in Body Mass Index

    Time frame: Baseline, 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.

  12. Change from Baseline in Body Mass

    Time frame: Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.

  13. Change from Baseline in Quality & satisfaction with life by SF Community - short-form survey (SF-12™) Colombian version

    Time frame: Baseline and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.

  14. Augmentation index (AIx)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Universidad Santo Tomas

Other

Registry information

Official study title

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

Acronym: HIIT-Heart

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 14, 2016
Registry last updated
Oct 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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